PharmaShots Weekly Snapshots (Jan 11 – 15, 2021)

Novartis’ Ligelizumab (QGE031) Receives the US FDA’s Breakthrough Designation for Patients with Chronic Spontaneous Urticaria

Published: Jan 15, 2020 | Tags: Novartis’, Ligelizumab (QGE031), Receives ,US FDA’s, Breakthrough Designation for Patients , Chronic Spontaneous Urticaria

Philips Collaborates with Merck KGaA to Advance Personalized Fertility Treatment

Published: Jan 15, 2020 | Tags: Philips, Collaborates, Merck KGaA, Advance Personalized Fertility Treatment

Henlius’ HLX15 (biosimilar, daratumumab) Receives IND Approval for Multiple Myeloma in China

Published: Jan 15, 2020 | Tags: Henlius’, HLX15 (biosimilar, daratumumab), Receives, IND, Approval, Multiple Myeloma in China

Abbott to Launch NeuroSphere myPath App to Record Pain Relief in Chronic Pain Patients

Published: Jan 15, 2020 | Tags: Abbott, Launch, NeuroSphere myPath App, to Record Pain Relief in Chronic Pain Patients

Pfizer’s Xalkori (crizotinib) Receives the US FDA’s Approval for ALK-Positive Anaplastic Large Cell Lymphoma in Children And Young Adult

Published: Jan 15, 2020 | Tags: Pfizer’s, Xalkori (crizotinib), Receives, US FDA’s, Approval, ALK-Positive Anaplastic Large Cell Lymphoma In Children And Young Adult

 Takeda and KSQ Collaborate to Develop and Commercialize Novel Immuno-Oncology Therapies

Published: Jan 15, 2020 | Tags: Takeda, KSQ, Collaborate, Develop, Commercialize, Novel Immuno-Oncology Therapies

BeiGene’s Tislelizumab (BGB-A317) + CT Receive NMPA’s Approval as 1L Therapy for Advanced Squamous NSCLC

Published: Jan 14, 2020 | Tags: BeiGene, Tislelizumab, (BGB-A317), CT, Receive ,NMPA, Approval ,1L Therapy, Advanced Squamous NSCLC

Sanofi Signs a License Agreement with Biond for BND-22

Published: Jan 14, 2020 | Tags: Sanofi, Signs, License Agreement, Biond, BND-22

Celltrion Report Results of CT-P59 in P-II/III Study for COVID-19

Published: Jan 14, 2020 | Tags: Celltrion, Report, Results, CT-P59, P-II/III, Study, COVID-19

ViiV Healthcare’s Tivicay (dolutegravir, dispersible tablets) Receives the EMA’s Approval for Children with HIV

Published: Jan 14, 2020 | Tags: ViiV Healthcare, Tivicay, dolutegravir, dispersible tablets, Receives, EMA, Approval, Children, HIV

Amgen Collaborates with Evoq to Develop Novel Therapies for Autoimmune Disorders

Published: Jan 14, 2020 | Tags: Amgen, Collaborates, Evoq, Develop, Novel Therapies, Autoimmune Disorders

Kamada to Commercialize Three Biosimilar Products in Israel

Published: Jan 14, 2020 | Tags: Kamada, Commercialize, Three Biosimilar, Israel

The US Government to Purchase Additional Doses of Regeneron’s Casirivimab and Imdevimab to Combat COVID-19

Published: Jan 13, 2020 | Tags: US, Government, Purchase, Additional Doses, Regeneron, Casirivimab, Imdevimab, COVID-19

Teladoc Health and Dexcom Offers CGM-Powered Insight for T2D

Published: Jan 13, 2020 | Tags: Teladoc Health, Dexcom, Offers, CGM-Powered, T2D

UCB Launches Nile AI as a Digital Health Company to Transform the Course of Epilepsy

Published: Jan 13, 2020 | Tags: UCB, Launches, Nile AI, Digital Health Company, Transform, Course of Epilepsy

Bayer Reports the US FDA’s Acceptance of NDA and Grants Priority Review for Finerenone (BAY 94-8862) to Treat CKD and T2D
Published: Jan 13, 2020 | Tags: Bayer, Reports, US, FDA, Acceptance, NDA, Priority Review , Finerenone, (BAY 94-8862), CKD, T2D

Gilead Collaborates with VIR to Evaluate Combination Therapy for Chronic Hepatitis B Virus

Published: Jan 13, 2020 | Tags: Gilead, Collaborates, VIR, Evaluate, Combination Therapy, Chronic Hepatitis B Virus

GSK and VIR Biotechnology to Evaluate VIR-7832 in the Early Treatment of COVID-19

Published: Jan 12, 2020 | Tags: GSK and VIR, Biotechnology, Evaluate, VIR-7832, Early Treatment, COVID-19

Roche Reports Updated OS Data of Tecentriq + Avastin in P-III IMbrave150 Study for Unresectable HCC

Published: Jan 12, 2020 | Tags: Roche, Reports, Updated OS Data, Tecentriq, Avastin, P-III, IMbrave150 Study, Unresectable HCC

AstraZeneca Collaborates with Adaptive on Mapping Immune Response in Cancer

Published: Jan 12, 2020 | Tags: AstraZeneca, Collaborates, Adaptive, Mapping, Immune Response, Cancer

Bluebird bio to Spin Off its Oncology Business into Independent Company

Published: Jan 12, 2020 | Tags: Bluebird bio, Spin Off, Oncology Business, Independent Company

Novartis In-Licenses BieGene’s Tislelizumab to Expand its Oncology Portfolio

Published: Jan 12, 2020 | Tags: Novartis, In-Licenses, BieGene, Tislelizumab, Oncology Portfolio

 Biogen and Apple Collaborate to Launch Virtual Study on Cognitive Decline

Published: Jan 12, 2020 | Tags: Biogen, Apple, Collaborate, Launch, Virtual Study, Cognitive Decline

BMS Collaborates with ArsenalBio to Advance Next-Generation T cell Therapies for Solid Tumors

Published: Jan 11, 2020 | Tags: BMS, Collaborates, ArsenalBio, Advance, Next-Generation, T cell Therapies,  Solid Tumors

Chi-Med and Inmagene Collaborate to Develop Therapies for Immunological Diseases

Published: Jan 11, 2020 | Tags: Chi-Med, Inmagene, Collaborate, Immunological Diseases

Sanofi to Acquire Kymab for ~$1.45B

Published: Jan 11, 2020 | Tags: Sanofi, Acquire, Kymab, ~$1.45B

BioMarin Reports Results of Valoctocogene Roxaparvovec in P-III GENEr8-1 Study for Hemophilia A

Published: Jan 11, 2020 | Tags: BioMarin, Reports, Results, Valoctocogene Roxaparvovec, P-III, GENEr8-1 Study, Hemophilia A

Roche’s Xofluza Receives the EC’s Approval for the Treatment of Influenza

Published: Jan 11, 2020 | Tags: Roche, Xofluza, Receives, EC, Approval, Treatment, Influenza

AbbVie Reports Results of Skyrizi (risankizumab) in P-III Induction Studies for Crohn’s Disease

Published: Jan 11, 2020 | Tags: AbbVie, Reports, Results, Skyrizi, (risankizumab), P-III, Induction Studies, Crohn’s Disease

Related Post: PharmaShots Weekly Snapshot (Jan 4-8, 2020)

The post PharmaShots Weekly Snapshots (Jan 11 – 15, 2021) first appeared on PharmaShots.

Novartis’ Ligelizumab (QGE031) Receives the US FDA’s Breakthrough Designation for Patients with Chronic Spontaneous Urticaria

Shots:

  • The US FDA has granted BTD for Ligelizumab for the treatment of CSU in patients with an inadequate response to H1-antihistamine treatment
  • The therapy is currently being evaluated in ongoing P-III program including PEARL 1 & -2 that assess Ligelizumab vs Xolair (omalizumab) in ~2000 patients across the globe with its anticipated results in H2’21
  • Ligelizumab is a next generation monoclonal anti-IgE Ab, that demonstrated more patients experienced complete resolution of wheals (hives) in a P-IIb dose-finding trial. The company is anticipating the US regulatory submission in 2022

Click here ­to­ read full press release/ article | Ref: Novartis | Image: Medical, Marketing and Media

The post Novartis’ Ligelizumab (QGE031) Receives the US FDA’s Breakthrough Designation for Patients with Chronic Spontaneous Urticaria first appeared on PharmaShots.

PharmaShots’ Key Highlights of Fourth Quarter 2020

  • The fourth quarter of 2020 contains multiple initiations of clinical trials, big approvals, and numerous deals. COVID-19 related news remains at the peak in this quarter
  • Multiple companies received regulatory bodies’ EUA for their vaccines and treatments for COVID-19. Initiating with, Regeneron sought the US FDA’s EUA for REGN-COV2 Ab combination while Health Canada accelerated the review for AZ’s COVID-19 vaccine. Meanwhile, AZ’s AZD1222 met its primary endpoint in preventing COVID-19
  • Our team at PharmaShots has summarized and complied with the insights of Q4’20

Sanofi Launches Tetraxim (DTaP-IPV) for Preschoolers in India

Date – Oct 01, 2020

Product – Tetraxim

  • Sanofi’s Tetraxim combines four vaccines into one and provides protection against four diseases – Diphtheria, Pertussis, Tetanus and Polio. The launch reduces the number of injections, increases comfort, and improves vaccination compliance for children
  • Booster vaccines are designed to boost the immunity acquired during prior vaccination. With the launch, Sanofi currently protects school children in 100+ countries, with 63M doses distributed globally
  • Tetraxim (DTaP-IPV) is a 4-in-1 booster vaccine and the only inactivated poliomyelitis containing combination vaccine in India that has full-dose antigenic strength of Diphtheria, Tetanus and acellular Pertussis (whooping cough) for preschoolers

BioMarin Receives the US FDA’s Approval Allowing Maximum Dose of 60mg with Palynziq (pegvaliase-pqpz) for PKU

Date – Oct 08, 2020

Product – Palynziq (pegvaliase-pqpz)

  • The US FDA has approved the sBLA to increase the maximum allowable dose of 60mg with Palynziq for PKU. Previously, the maximum dose was 40mg
  • The label expansion is based on OLE study out to 3yrs. demonstrating that 66% had a blood Phe level ≤360 μmol/L consistent with the Phe target ACMG recommended guidelines @2yrs. of treatment and 50% had blood Phe levels ≤120 μmol/L @2yrs. 75%, 66% & 48% had a blood Phe ≤600, 360, and 120 μmol /L, respectively @3yrs. of treatment
  • Additional, safety data with over 6yrs. of follow up remains consistent with the previous safety profile of Palynziq irrespective of dose. Moreover, BioMarin has dosed the first participant in the global Phearless P-I/II study of BMN 307 for PKU

AbbVie Reports Results of Skyrizi (risankizumab) in P-III LIMMitless Study in Patients with Moderate to Severe Plaque Psoriasis

Date – Oct 08, 2020

Product – Skyrizi (risankizumab)

  • The P-III LIMMitless study is designed to evaluate the long-term safety & efficacy assessing risankizumab (150 mg q12wks.) continuous risankizumab with a loading dose in adults with moderate to severe plaque psoriasis. The analysis includes integrated data from five P-II & III studies (ultIMMa-1, ultIMMa-2, SustaIMM, IMMvent and NCT03255382) and the LIMMitless study
  • Results: ~63% of patients with moderate to severe plaque psoriasis treated with SKYRIZI achieved completely clear skin for 172 wks., as measured by 100% improvement from baseline in the PASI 100. New results from the P-III LIMMitless study were presented at the 29th EADV Virtual Congress
  • Risankizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. It is part of a collaboration between Boehringer Ingelheim & AbbVie, with AbbVie leading development & commercialisation globally

Regeneron Seeks the US FDA’s EUA for REGN-COV2 Antibody Combination to Treat COVID-19

 Date – Oct 09, 2020

 Product – REGN-COV2

  • Regeneron has submitted a request to the US FDA seeking EUA for its REGN-COV2 investigational Ab regimen to treat COVID-19. If EUA is granted, the US govt. has committed to making REGN-COV2 available in the US at no cost and would be responsible for its distribution
  • The company reported that there are doses available for ~50,000 patients and expects to have doses available for 300,000 patients in total within the next few months
  • REGN-COV2 is a combination of two mAbs, REGN10933 & REGN10987, designed to block the infectivity of SARS-CoV-2. The company reported that a single 8g dose of REGN-COV2 was given to President Donald Trump following a compassionate-use request from doctors as part of a treatment regimen

Boehringer Ingelheim Initiates P-II Study of BI 764198 for Patients with Severe Respiratory Illness from COVID-19

 Date – Oct 29, 2020

 Product – BI 764198

  • The P-II trial will assess BI 764198 (qd for ~4wks.) in patients hospitalized for COVID-19 with expected enrollment initiation in Oct’2020. The 1EPs will be the percentage of patients who are alive and free of mechanical ventilation at day 29 of treatment while other EPs include clinical improvement, oxygen saturation & ICU admission
  • The therapy has shown a reduction in cellular damage and lung edema in preclinical studies and may provide similar benefits in patients with severe SARS-CoV-2 infection. BI 764198 was well tolerated in P-I study in healthy adults
  • BI 764198 is potent & selective inhibitor of TRPC6, focusing to reduce the need for ventilator support and to improve patient recovery rate

Roche’s Tecentriq in Combination with Avastin Receives China NMPA’s Approval for the treatment of Unresectable Hepatocellular Carcinoma

Date – Oct 30, 2020

Product – Tecentriq + Avastin

  • The approval was based on the P-III IMbrave150 study (n=501) assessing the combination of Tecentriq (1200 mg, IV) and Avastin (15 mg/kg, IV) or sorafenib (400 mg, bid) in unresectable HCC patients who had not received prior systemic therapy which included analyses of a cohort of Chinese patients (n=194) from the same study
  • Results: Tecentriq in combination with Avastin reduced the risk of OS by 56% (among Chinese patients) and 42% (global results) & the PFS risk by 40% (among Chinese patients) and 41% (global results) as compared with sorafenib
  • IMbrave150 is the 1st P-III cancer immunotherapy study to show an improvement in OS and PFS in people with unresectable or metastatic HCC compared with sorafenib. Additionally. in May 2020, the US FDA approved Tecentriq in combination with Avastin for the treatment of people with unresectable or metastatic HCC who have not received prior systemic therapy

Sanofi Entered into an Agreement with Merck to Conduct a P-II Study of THOR-707 in Sequenced Administration with MSD’s Keytruda (pembrolizumab) in Patients with Various Cancers

 Date – Oct 30, 2020

 Product – Keytruda

  • Sanofi will sponsor the clinical trials while MSD will provide KEYTRUDA. Additionally, Sanofi is separately evaluating the activity of THOR-707 in combination with other anti-PD-1 antibodies, including Libtayo (cemiplimab-rwlc) and with anti-EGFR and anti-CD38 antibodies for various types of cancer tumors
  • In preclinical studies, THOR-707 demonstrated the ability to induce the expansion of CD8+T-cells resulting in anti-tumor effects both as a single agent as well as in combination with an anti-PD1 mAb
  • THOR-707 is currently being evaluated by Sanofi in an ongoing P-I dose escalation and expansion trial assessing THOR-707 and determining its recommended P-II dose alone and in combination with anti-PD-1 and anti-EGFR antibodies

Janssen Reports Results of Tremfya (guselkumab) in Interim Analysis of P-II GALAXI 1 study for Moderately to Severely Active Crohn’s Disease

 Date – Oct 30, 2020

  Product – Tremfya

  • The P-II GALAXI 1 study involves assessing of Tremfya vs PBO in patients with mod. to severely active CD with intolerance to conventional therapies. In interim analyses, patients were randomized equally into 5 arms, with Tremfya (200/600/1200 mg (IV) @0, 4 & 8wks. respectively or with ustekinumab, dosed at ~6mg/kg (IV) @0wk. and dosed 90 mg (SC) @8wks. or PBO
  • @12wks. (Tremfya vs PBO), reductions in CDAI (154.1, -144.3, -149.5 vs -36.0); patients achieving clinical remission vs PBO (CDAI<150): (54.0%, 56.0%, 50.0% vs 15.7%); clinical remission among conventional therapy failures & among patients who had previously failed biologic therapy, (61.6% vs 18.5% & 45.5% vs 12.5%) respectively
  • @12wks, Tremfya induced greater improvement across key clinical and endoscopic outcome measures, with a safety profile consistent with approved indications. Tremfya is a mAb that selectively binds to the p19 subunit of (IL)-23 and inhibits its interaction with the IL-23 receptor

Pfizer & BioNTech Receives MHRA’s EUA for BNT162b2 Against COVID-19

Date – Nov 02, 2020

Product- BNT162b2

  • Pfizer & BioNTech reports that the MHRA in the UK has granted a temporary authorization for the EU for BNT162b2 against COVID-19. The distribution of vaccine will be prioritized according to the populations identified in guidance from the JCVI
  • The MHRA’s decision is based on a rolling submission, including data from the P-III study, demonstrating 95% efficacy in participants without & with/ out prior SARS-CoV-2 infection, in each case measured from 7 days after the second dose
  • This marks the first EUA following a WW P-III trial of a vaccine to combat the pandemic. The companies are anticipating further regulatory decisions across the globe in Dec’2020

AstraZeneca to Divest European Rights of Crestor (rosuvastatin) to Grünenthal for ~$350M

Date – Nov 02, 2020

Product- Crestor

  • Grünenthal to acquire EU rights (Ex- Spain and the UK) of Crestor & its associated brands for ~$350M and will take over bulk production and packaging by 2025. The deal is expected to be closed in Q1’21
  • The payments will be made in two tranches: $320M will be paid upon transaction closing and $30M as additional milestones
  • Crestor is a statin, a lipid-lowering agent used to treat blood-lipid disorders & to prevent CV events, such as heart attacks & strokes, and is approved as a lipid-regulating medicine in 100+ countries

Genentech and Novartis’s Xolair (omalizumab) Receives the FDA’s Approval for Adults with Nasal Polyps

Date – Nov 02, 2020

Product- Xolair

  • The approval is based on P-III POLYP 1 & 2 trials assessing Xolair vs PBO in 138 & 127 adult patients with nasal polyps who had an inadequate response to nasal corticosteroids respectively
  • Results: @24wks. improvement in NPS (-1.1 vs 0.1 & -0.9 vs -0.3); improvement in NCS (-0.9 vs -0.4 & -0.7 vs -0.2); no new or unexpected safety signals were identified respectively
  • Xolair is the first biologic for the treatment of nasal polyps that targets and blocks IgE. In the US, Novartis & Genentech work together to develop and co-promote Xolair

Celltrion Presents Results of CT-P17 (biosimilar, adalimumab) in P-III Study for RA at ACR 2020

Date – Nov 03, 2020

Product – CT-P17(biosimilar,adalimumab)

  • The P-III study involves assessing CT-P17 (40mg, q2w) vs reference adalimumab for up to 24wks. in 648 patients with active moderate-to-severe RA despite MTX treatment
  • Results demonstrated that CT-P17 has equivalent efficacy to reference adalimumab i.e. ACR20 is 82.7% for both, 2EPs include ACR20/50/70 response rates, mean DAS28, CDAI & SDAI & EULAR (CRP) response, Ctrough of adalimumab is higher for CT-P17 & lower in the ADA positive subgroup than the ADA negative subgroup in both treatment groups, the safety profile is comparable
  • Additionally, comparable PK and safety data is presented for CT-P17 in comparison with EU-approved & US-licensed adalimumab in 312 healthy subjects. Celltrion also presented PK and safety data for two delivery methods for CT-P17, the auto-injector (AI) and pre- filled syringe (PFS)

AstraZeneca and Fusion Collaborate to Develop and Commercialize Radiopharmaceuticals and Combination Therapies for Cancer

Date – Nov 03, 2020

Product – FPI-1434

  • Fusion to receive up front, as well as development milestones and other payments. The companies will jointly discover, develop, and have an option to co-commercialize novel TATs in the US while AstraZeneca will lead commercialization in the ROW with equal profit & loss sharing globally
  • The collaboration leverages Fusion’s TAT platform and expertise in radiopharmaceuticals with AstraZeneca’s leading portfolio of Abs and cancer therapies, including DDRis
  • Additionally, the companies will exclusively explore certain specified combination strategies between TATs (including Fusion’s FPI-1434) and AstraZeneca’s therapies for the treatment of multiple cancers. Both companies will retain full rights to their respective assets

Janssen Acquires Rights to Hemera’s HMR59 for Late-Stage Age-Related Macular Degeneration

Date – Nov 03, 2020

Product- HMR59

  • Janssen acquires rights to Hemera’s HMR59, administered as a one-time, outpatient, IVT inj. to help preserve vision in patients with geographic atrophy
  • The acquisition will boost Janssen’s eye disease portfolio & strengthens its gene therapy capabilities
  • HMR59 is designed to increase the ability of retina cells to make a soluble form of CD59, helping to prevent further damage to the retina and preserve vision. The P-I study of the therapy for patients with geographic atrophy is completed while the P-I study exploring HMR59 in patients with wet-AMD is currently conducting follow-up visits to evaluate the long-term safety

BMS’ Deucravacitinib (BMS-986165) Demonstrate Superiority Over Amgen’ Otezla (apremilast) in P-III POETYK PSO-1 Study for Plaque Psoriasi

Date – Nov 04, 2020

Product- Deucravacitinib

  • The P-III POETYK PSO-1 study involves assessing deucravacitinib (6mg, qd) vs PBO & Otezla (apremilast) in 666 patients with moderate to severe plaque psoriasis
  • The trial met its co-1EPs & 2EPs demonstrating deucravacitinib was superior to Otezla (apremilast) in the patients reaching a PASI 75 and sPGA 0/1 @16wks. The overall safety profile of deucravacitinib was consistent with previously reported P-II results
  • Deucravacitinib (BMS-986165, PO) is the first & only novel selective TYK2 inhibitor, currently being evaluated in psoriasis, PsA, lupus, and IBD

Janssen Reports BLA Submission of Amivantamab to the US FDA for Metastatic NSCLC with EGFR Exon 20 Insertion Mutations

Date – Nov 04, 2020

Product- amivantamab

  • The BLA is based on the P-I CHRYSALIS study assessing amivantamab as a monothx. and in combination with lazertinib in adult patients with advanced NSCLC
  • The company has established an EAP for patients in the US who may be eligible to obtain access to mivantamab during the review of the BLA
  • Amivantamab is an EGFR & MET bispecific Ab with the immune cell-directing activity that targets tumors with activating & resistance to EGFR & MET mutations & amplifications. Amivantamab has received the US FDA’s BTD in Mar’2020

Merck to Acquire VelosBio for $2.75B

Date – Nov 05, 2020

Product- VLS-101

  • Merck will acquire all the outstanding shares of VelosBio for $2.75B in cash. The transaction is expected to be closed by the end of 2020
  • The acquisition will bolster Merck’s oncology pipeline with the addition of VelosBio’s VLS-101, which is an investigational ADC targeting ROR1 to treat hematological malignancies and solid tumors
  • In Oct’2020, VelosBio has initiated P-II study to evaluate VLS-101 for the treatment of patients with solid tumors, including patients with TNBC, HR+/HER2+ BC, and NSCLC. Additionally, VelosBio is developing a preclinical pipeline of ADCs and bispecific Abs targeting ROR1 to complement VLS-101 by offering alternative methods of tumor cell killing

Merck KGaA Collaborates with Iktos to Deploy AI in New Drug Design

Date – Nov 05, 2020

Product- N/A

  • Iktos will leverage its de novo generative design technology to be used in a structure-enabled context, facilitating the rapid & cost-effective design of Merck KGaA’s drug discovery program
  • The collaboration follows the previous agreement of the companies signed in 2019. Merck KGaA is utilizing Iktos’ de novo design software platform Makya for MPO
  • Iktos’ AI technology is based on deep generative models that help bring speed & efficiency to the drug discovery process by automatically designing virtual novel molecules having desired activities for treating a disease

Novavax Collaborates with Commonwealth of Australia to Supply 40M doses of NVX-CoV2373 for COVID-19

Date – Nov 05, 2020

Product- NVX-CoV2373

  • Novavax has signed a non-binding Heads of Terms document with the Australian Government to supply 40M doses of NVX-CoV2373 for the Australian community
  • The delivery will start as early as H1’21, following the completion of P-III study and the TGA’s approval of the vaccine. The vaccine regimen is expected to require two doses per individual, administered 21 days apart.
  • NVX-CoV2373 is evaluated in P-ll trial in the UK and 2 ongoing P-ll studies that began in Aug’2020, a P-llb trial in SA, and a P-l/ll continuation in the US and Australia. Additionally, Novavax has multiple agreements for the supply of NVX-CoV2373 directly to the US, UK, Canada, and through partnerships, supply to Japan, South Korea, and India

Roche Presents Results of Hemlibra Reinforcing the Long-Term Benefits for Hemophilia A at ASH 2020

Date – Nov 07, 2020

Product- Hemlibra

  • The 4 pivotal HAVEN studies (HAVEN-1, 2, 3, 4) included pooled data from 401 people with hemophilia A with/ out factor VIII inhibitors, with a median duration efficacy period of 120.4wks.
  • Hemlibra maintained low treated bleed rates with ABR remaining low throughout the evaluation period at 1.4. The proportion of participants who experienced 0 treated bleeds (70.8-83.7%) increased with each consecutive 24wks. period
  • Roche also presented the first interim analysis of the EUHASS database suggesting that the safety profile of Hemlibra in the real-world setting is consistent with the clinical trials, with no new/ emerging safety signals. Hemlibra is a bispecific factor IXa- and factor X-directed Ab

Celltrion Reports Results of CT-P59 in P-I Study for COVID-19

Date – Nov 09, 2020

Product – CT-P59

  • The P-I clinical trial involves assessing CT-P59 (20/40/80 mg/kg) vs PBO in 18 patients with mild symptoms of SARS-COV-2 infection who were randomized into 3 cohorts
  • Results: patients demonstrated a 44% reduction in mean clinical recovery time, while no patients required hospitalization or antiviral therapy
  • Celltrion has submitted the IND application for the clinical trial globally & plans to conduct global P-II & P-III trials including Korea. Additionally, Celltrion has also initiated a post-exposure prophylaxis study assessing CT-P59 as a protective treatment, by investigating the efficacy of the treatment in those who have been in contact with confirmed SARS-CoV-2 infected patients

AstraZeneca’s Calquence (acalabrutinib) Receives EU’s Approval for Chronic Lymphocytic Leukaemia

Date – Nov 10, 2020

Product- Calquence (obinutuzumab)

  • The approval is based on P-lll ELEVATE-TN study assessing Calquence + obinutuzumab or Calquence alone vs obinutuzumab + CT in patients with previously untreated CLL and ASCEND study assessing Calquence vs rituximab + idelalisib/ bendamustine in patients with r/r CLL
  • ELEVATE-TN results: a reduction in the risk of disease progression or death (90% and 80%). ASCEND results: patients remained alive and free from disease progression @12mos. (88% vs 68%)
  • Calquence is a selective inhibitor of BTK, binds covalently to BTK, thereby inhibiting its activity. The approval follows CHMP’s recommendation received in Jul’2020

Pfizer Reports Results of Abrocitinib in Fifth P-lll JADE REGIMEN Across Different Dosing Regimens

Date – Nov 12, 2020

Product- Abrocitinib

  • The P-lll JADE REGIMEN study involves assessing of Abrocitinib (100/ 200mg) vs PBO in 1233 patients aged ≥ 12 yrs. in a ratio (1:1:1) with mod. to sev. AD following response to initial open-label induction treatment with abrocitinib (200mg)
  • Result: The study met its 1EPs i.e. probability of not experiencing a flare @52wks. (81.1%, 57.4% vs 19.1%) and 2EPs i.e. patients maintain an IGA response of clear or almost clear relative
  • Following an initial 12wks. induction treatment phase, fewer patients experienced a flare at any point in the trial @40wks. Abrocitinib is a JAK inhibitor, which modulates multiple cytokines involved in the pathophysiology of AD, including IL-4, IL-13, IL-31, IL-22, and TSLP

UCB Acquires Handl Therapeutics to Augment its Gene Therapy Portfolio

Date – Nov 13, 2020

Product – Handl Therapeutics

  • The acquisition will bolster UCB’s pipeline program, capabilities, and platforms in the gene therapy space. The Handl Therapeutics will continue to be based in Leuven, Belgium while working closely with UCB’s international research teams
  • In addition, the UCB collaborated with Lacerta to focus on CNS diseases, under which Lacera will lead research, preclinical activities, and the early manufacturing process development, while UCB will complete IND-enabling studies, manufacturing, and clinical development
  • The collaboration will allow UCB to access Lacerta’s expertise in AAV-based CNS targeted gene therapies, fortifying UCB’s ability to produce effective treatments for neurodegenerative diseases

Henlius report the NMPA’s Acceptance of HLX15(biosimilar, Daratumumab) to treat multiple myeloma

Date – Nov 16, 2020

Product- HLX15  

  • The NMPA has accepted HLX15’s IND to be used in the treatment of multiple myeloma. HLX15 is Henlius’ second self-developed product around blood tumor treatment
  • The company evaluated the biosimilar in a head to head clinical studies demonstrating that HLX15 is highly similar to its reference daratumumab while the safety profiles are also similar
  • The company has developed the HLX15 in accordance with the technical guidelines of development and evaluation of biosimilar drugs and EMA guideline on similar biological medicinal products

Pfizer Launches US Pilot Programme for Delivery and Distribution of COVID-19 Vaccine, BNT162b2

Date – Nov 20, 2020

Product- BNT162b2

  • collaborate to focus at developing & commercializing transformative therapies in Greater China. Both the companies will leverage their clinical development, regulatory and commercial expertise
  • Pfizer will contribute ~$70M of non-dilutive capital toward in-licensing & co-development. At LianBio’s discretion, products will be presented to Pfizer for joint development
  • Pfizer will have a right of first negotiation to obtain commercial rights to jointly developed assets & each company will carry separate financial considerations. Additionally, Pfizer may provide in-kind support for marketing, development & regulatory activities

AstraZeneca’s AZD1222 Meets its Primary Endpoint in Preventing COVID-19

Date – Nov 23, 2020

 Product – AZD1222

  • Interim analysis results of COV002 & COV003 study of AZD1222 in the UK & Brazil showed the vaccine is effective in preventing COVID-19 and no hospitalizations/ severe cases of the disease were reported
  • One dosing regimen showed an efficacy of 90% when AZD1222 was given as a half dose, followed by a full dose of at least 1 mos. apart & another dosing regimen showed 62% efficacy when given as 2 full doses at least 1 mos. apart. The combined analysis from both dosing regimens resulted in the efficacy of ~70%
  • AZ will plan regulatory submission of the data across the globe and will seek an Emergency Use Listing from the WHO for an accelerated pathway to vaccine availability in low-income countries.

Roche Launches Cobas PIK3CA Mutation Test for Patients with Advanced or Metastatic Breast Cancer

Date – Dec 15, 2020

Product- Cobas PIK3CA Mutation Test

  • Roche launches the cobas PIK3CA mutation test for patients with advanced/ m-BC in countries accepting the CE mark
  • The IVT test is a real-time PCR test for the qualitative detection & identification of 17 mutations in exons 2, 5, 8, 10 & 21 in the gene encoding the catalytic subunit of PIK3CA in DNA isolated from FFPET and is intended to identify patients with m-BC harboring mutations
  • This test reports automated results, with flexible throughput to process 30 samples/ run on the widely available cobas z 480 analyzers. The test can detect 17 mutations in the PIK3CA gene and can help clinicians to identify patients who may benefit from PI3K targeted therapy

Abbott’s COVID-19 IgG Quantitative Antibody Blood Test Receives CE Mark

Date – Dec 16, 2020

Product- SARS-CoV-2 IgG II Quant test

  • Abbott received CE Mark for its new quantitative SARS-CoV-2 IgG lab-based serology test. The test measures levels of IgG Abs to help in the evaluation of a person’s immune response
  • The study to determines the clinical performance of Abbott’s SARS-CoV-2 IgG II Quant test on its Alinity i instrument showed that it had 99.60% specificity & 99.35% sensitivity in patients tested 15 days or more after symptoms began
  • The test will be available on both the Abbott ARCHITECT and Alinity i platforms. Abbott plans to submit its test for US FDA’s EUA imminently

Health Canada Accelerates the Review for AstraZeneca’s COVID-19 Vaccine

Date – Dec 15, 2020

Product- COVID-19 vaccine

  • Health Canada expedite the review of AstraZeneca’s COVID-19 vaccine after the vaccine received the UK’s MHRA approval for emergency use
  • Following an agreement to supply 20M of doses for the Government of Canada, AstraZeneca seek out Health Canada’s clearance in Oct’2020, leading to data submission done on a rolling basis for accelerating the review process
  • Health Canada is looking to give Canadians access to COVID-19 vaccines asap without compromising its safety, efficacy, and quality standards

Related Post: PharmaShots’ Key Highlights of Third Quarter 2020

The post PharmaShots’ Key Highlights of Fourth Quarter 2020 first appeared on PharmaShots.

Birinapant licensing; AvantGen, IGM pairs up for anti-SARS-CoV-2 antibodies; BeiGene, Novartis to co-dvelop Tislelizumab; Valo raises USD190 M; Bluebird Bio Spins-off

Medivir, IGM Biosciences enters into an exclusive licensing agreement for Birinapant

Medivir AB has entered into an exclusive licensing agreement with IGM Biosciences to receive global, exclusive development rights for Birinapant. Birinapant is a clinical-stage SMAC mimetic that degrades Inhibitors of Apoptosis Proteins (IAPs) by binding to them, ultimately leading to cell death in tumor cells. 

Further, Birinapant also complements the anti-tumor activity of the immune system. Thus, the drug appears to be a promising therapeutic agent in treating different forms of cancer in combination with other drugs. IGM-8444 is another drug that is currently being tested in a phase I dose-escalation study in patients with solid and hematologic malignancies by IGM Biosciences. It is an IgM antibody targeting Death Receptor 5 (DR5), and IGM is hoping to test Birinapant with IGM-8444 for the treatment of solid cancers later this year. 

As per the terms and conditions of the agreement, Medivir is eligible to receive an upfront payment of USD 1 million, followed by an additional USD 1.5 million after Birinapant successfully becomes a part of the Phase I trials. Medivir is also eligible to receive milestone payments up to a total of approximately USD 350 million, plus tiered royalties up to mid-teens on net sales upon the commercial approval of the drug. 

AvantGen Enters into a Licensing Agreement for its Anti-SARS-CoV-2 Antibodies with IGM Biosciences 

AvantGen has announced the licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development. It is a panel of high-affinity human monoclonal antibody clones, which binds to two distinct epitopes on the receptor-binding domain of the SARS-CoV-2 spike protein, thereby blocking the spike protein from interacting with ACE2. This eventually averts virus-induced cell-killing, also known as cytopathic effect.

Under the licensing agreement, IGM Biosciences receives the rights to convert the antibody clones into IgA or IgM format for further development for the treatment of COVID-19. While AvantGen received an upfront payment and is eligible to receive milestone and royalty payments.

The companies believe that their candidate in its original IgG format has shown potent neutralization activity in in vitro assays and in an in vivo animal model. This will have an advantage over the multiple vaccines that have been getting EUA, which are not suitable for immunocompromised patients. 

BeiGene, Novartis partner to develop cancer drug Tislelizumab, an Anti-PD-1 Antibody 

BeiGene has announced the collaboration with Novartis Pharma AG to develop, manufacture, and commercialize BeiGene’s anti-PD-1 antibody tislelizumab in the United States, Canada, Mexico, member countries of the European Union, United Kingdom, Norway, Switzerland, Iceland, Liechtenstein, Russia, and Japan. 

Already in markets in China, BeiGene’s Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. It is approved for classical Hodgkin’s lymphoma (cHL) following at least two prior therapies and locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression. 

The duo will jointly develop the therapy, conducting clinical trials globally. BeiGene is eligible to receive an upfront cash payment of USD 650 million, up to USD 1.3 billion upon achieving regulatory milestones, USD 250 million for sales milestones, and royalties on future sales of tislelizumab in the licensed territory. At the same time, Novartis will take care of regulatory submissions after a transition period and for commercialization upon regulatory approvals. Besides, BeiGene has an option to co-detail the product in North America, which will be funded in part by Novartis.

Valo Raises USD 190 Million in Series B Financing and Unveils Select Therapeutic Programs

Valo has announced the closing of a USD 190 million Series B financing and unveiled select therapeutic programs. The company is creating a new systemic approach for drug discovery and development. The proceeds from Series B will continue to support the discovery and development of therapeutic programs that the company is undertaking. Further, Valo plans to use the sum to advance its proprietary Opal Computational Platform and its build working capital. 

The company plans to combine its unique human-centric dataset (over 125-million patient-years) with its Opal Computational PlatformTM with an aim to leverage machine learning and patient data for the facilitated and speedy development of products at clinical stages. Some of the key preclinical programs that Valo proudly owns include NAMPT, PARP1, USP28, and HDAC3. 

The financing was led by The Public Sector Pension Investment Board (PSP Investments), along with Valo’s existing major investors, including Flagship Pioneering and several new institutional investors, including Invus Public Equities, HBM Healthcare Investments, Atinum Investment, and Mirae Asset Capital.  

Bluebird spins off to two companies, cleaving off its gene therapy, and cancer units

Bluebird bio recently announced its plans to split its genetic disease and oncology businesses. The company has decided to prioritize its severe genetic disease unit and form its oncology business into a new company.

The decision came after the company struggled to commercialize its gene therapies, and as a result, its stocks continue to stumble down. Recently, bluebird bio decided against filing for USFDA approval for its gene therapy for sickle cell disease (SCD) for at least a minimum of 2 years. 

Another of its therapy, bb1111, a LentiGlobin treatment for SCD, was building its submission on promising data from Group C pf the HGB-206 study. The company and the agency had reached an agreement on a path to transition to commercial manufacturing using an analytical comparability strategy, including a suspension-based lentiviral vector (sLVV).

The post Birinapant licensing; AvantGen, IGM pairs up for anti-SARS-CoV-2 antibodies; BeiGene, Novartis to co-dvelop Tislelizumab; Valo raises USD190 M; Bluebird Bio Spins-off appeared first on DelveInsight Business Research.

Novartis In-Licenses BieGene’s Tislelizumab to Expand its Oncology Portfolio

Shots:

  • BieGene to receive $650M as up front along with milestones and royalties and will retain rights to Tislelizumab in China and other countries
  • Novartis to get the development & commercialization rights to tislelizumab in the US, Canada, Mexico, EU, UK, Norway, Switzerland, Iceland, Liechtenstein, Russia, & Japan. Additionally, the companies have identified multiple tislelizumab + Novartis’ therapy combination clinical trial opportunities in solid tumors
  • Tislelizumab is an anti-PD-1 mAb, designed to minimize binding to FcγR on macrophages and is approved in China for patients with cHL and m-UC in China while 15 registration-enabling clinical trials under way in NSCLC and other solid tumors

Click here ­to­ read full press release/ article | Ref: Novartis | Image: Outsourcing Pharma

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Armed with $270M in capital, Scorpion Therapeutics aims to broaden the reach of precision oncology

bullseye, take aim

Founded in 2020, Scorpion is agnostic about the potential therapies and targets it will explore with what it describes as its drug-hunting engine. But the company is hoping to unveil its first drug candidate this year.

Top 20 Biopharma M&A of 2020 by Total Deal Value

  • Biopharma merger and acquisition activity in 2020 was mainly filled with late-stage, bolt-on acquisitions, which were orders of magnitude smaller than the mega M&A deals of prior years.
  • AstraZeneca holds the top rank by acquiring Alexion Pharmaceuticals among the top 20 acquisitions with a total deal value of $39B at a 1-day premium of 45% strengthening its capabilities in immunology, neurology, metabolic cardiovascular, nephrology, and rare disease.
  • This article is based on the 2020 deals data as provided by the DealForma database. Our team at PharmaShots compiled a list of the top 20 acquisitions of 2020 based on total deal value.

Deal Date: Dec 17, 2020

Deal Value: $0.77B 

Novartis acquired Cadent Therapeutics. The acquisition strengthens Novartis’ neuroscience portfolio with the addition of Cadent’s NMDAr program, including CAD-9303, an NMDAr positive allosteric modulator in Phase I for schizophrenia, and MIJ-821, an NMDAr negative allosteric modulator in Phase I for treatment-resistant depression. CAD-9303 and MIJ-821 were licensed to Novartis in 2015. Additionally, Novartis will gain full rights to CAD-1883, a clinical-stage SK channel positive allosteric modulator for movement disorders. Cadent Therapeutics received $210M up front and is eligible for up to $560M in milestones.

Deal Date: Aug 11, 2020

Deal Value: $0.87B

Bayer acquired KaNDy Therapeutics with its Phase IIb compound, NT-814, a small molecule for menopause and vasomotor symptoms. The acquisition strengthens Bayer’s drug development portfolio in women’s healthcare. KaNDy Therapeutics received $425M up front and is eligible for up to $450M in R&D milestones and additional undisclosed sales-based milestones.

Deal Date: Aug 25, 2020

Deal Value: $0.93B

ACADIA Pharmaceuticals acquired CerSci Therapeutics with its lead candidate, ACP-044, a Phase I small molecule for acute & chronic pain. The acquisition strengthens ACADIA’s non-opioid pain therapies portfolio. CerSci shareholders received $52.5M up front and are eligible for up to $887M in development and sales-based milestones.

Deal Date: Dec 15, 2020

Deal Value: $1.04B

Eli Lilly acquired Prevail Therapeutics. The acquisition strengthens Eli Lilly’s gene therapies portfolio with Prevail’s clinical and preclinical disease-modifying AAV9 gene therapy assets in neuroscience. Prevail’s pipeline includes PR001 in Phase I/II for Parkinson’s disease and in preclinical studies for neuronopathic Gaucher disease, and PR006 in Phase I/II for frontotemporal dementia with GRN mutations. Prevail shareholders received $880M up front at a purchase price of $22.50 per share which represents a premium of approximately 117% plus 1 non-tradable CVR worth up to $4.00 per share in cash (or an aggregate of approximately $160M), for a deal total of up to $26.50 per share in cash, approximately $1.04B. The CVR is payable upon the first regulatory approval for the commercial sale of a Prevail product in one of the countries, including the US, Japan, UK, Germany, France, Italy, or Spain.

Deal Date: Jan 10, 2020

Deal Value: $1.1B     

Eli Lilly acquired Dermira with its IL-13 inhibitor antibody lebrikizumab, which is in Phase III for moderate-to-severe atopic dermatitis, and its marketed QBREXZA (glycopyrronium) medicated cloth for the topical treatment of primary axillary hyperhidrosis (uncontrolled excessive underarm sweating). Dermira licensed lebrikizumab from Genentech/Roche, which acquired the compound when it acquired Tanox, the originator. Dermira shareholders received $18.75 per share in cash at a 1-day premium of 2.2% for approximately $1.1B.

Deal Date: Oct 15, 2020

Deal Value: $1.3B

Lilly acquired Disarm Therapeutics. The acquisition strengthens Lilly’s neurology portfolio with the addition of preclinical SARM1 inhibitors, a small molecule for peripheral neuropathy and other neurological diseases such as amyotrophic lateral sclerosis (ALS) and multiple sclerosis. Disarm shareholders received $135M up front and are eligible for up to $1.225B in development, regulatory, and commercial milestones if Lilly develops and commercializes new medicines based on Disarm’s approach.

Deal Date: May 5, 2020

Deal Value: $1.3B     

Alexion Pharmaceuticals acquired Portola Pharmaceuticals including its balance sheet and debt of approximately $215M. The acquisition expands Alexion’s hematology, neurology, and critical care portfolio. Portola shareholders received $18 per share in cash at a premium of 130% for a total of $1.38B.

Deal Date: Dec 10, 2020

Deal Value: $1.4B     

Boehringer Ingelheim acquired NBE-Therapeutics. The acquisition strengthens Boehringer Ingelheim’s oncology pipeline with NBE-002, Phase I immunoconjugates for TNBC, lung, and ovarian cancers. NBE-Therapeutics is eligible to receive up to EUR 1.18B ($1.428B).

Deal Date: Dec 10, 2020

Deal Value: $1.7B

Gilead Sciences acquired MYR. The acquisition strengthens Gilead’s infectious disease and liver disease portfolio with the addition of hepcludex, a lipoprotein approved for Hepatitis D in Europe and in Phase III for Hepatitis D, in Phase II for Hepatitis B, in Phase I for dyslipidemia, and in preclinical studies for NASH and primary biliary cholangitis. MYR shareholders received EUR 1.15B ($1.39B) up front and are eligible for up to EUR 300M ($363.7M) in milestones.

Deal Date: Nov 6, 2020

Deal Value: $1.8B     

Novo Nordisk acquired Emisphere Technologies for $1.8B. The acquisition strengthens Novo Nordisk’s biologics segment with the addition of Eligen SNAC drug delivery technology. Additionally, Novo Nordisk will buy out its Eligen SNAC royalty stream obligations with MHR Fund Management, Emisphere’s largest shareholder. Novo Nordisk partnered with Emisphere in 2007 to develop oral biologics by applying Eligen SNAC. Emisphere shareholders received $7.82 per share in cash representing a 15% 1-day premium at approximately $1.35B. Additionally, Novo Nordisk will pay $450M to MHR Fund in connection with its royalty stream obligations.

Deal Date: June 11, 2020

Deal Value: $2.1B

Novo Nordisk acquired Corvidia Therapeutics. The acquisition strengthens Novo Nordisk’s cardiovascular disease portfolio with Phase II ziltivekimab, an antibody for inflammatory cardiovascular risk in CKD patients. Corvidia received $725M up front and is eligible for up to $1.375B in regulatory and sales-based milestones.

Deal Date: Aug 31, 2020

Deal Value: $2.6B

Nestle acquired Aimmune Therapeutics. The acquisition strengthens Nestle’s food allergy portfolio with Palforzia, an approved protein for peanut allergy. Aimmune Therapeutics received $2.6B at $34.50 per share at a 1-day premium of 174%. Nestle previously acquired 25% of the company starting with their 2016 partnership.

Deal Date: Nov 5, 2020

Deal Value: $2.7B     

Merck acquired VelosBio. The acquisition strengthens Merck’s oncology pipeline with the addition of Phase II VLS-101 antibody-drug conjugate targeting ROR1 for hematologic malignancies and solid tumors plus preclinical ADCs and bispecific antibodies. VelosBio shareholders will receive $2.75B.

Deal Date: Aug 17, 2020

Deal Value: $3.6B     

Sanofi acquired Principia Biopharma. The acquisition strengthens Sanofi’s autoimmune and allergic diseases portfolio with tolebrutinib (SAR442168), a small molecule in Phase III for multiple sclerosis and in Phase II for CNS disorders. Principia Biopharma received $3.6B at a purchase price of $100 per share at a premium of 10%. In 2017, Sanofi and Principia partnered on the development and commercialization of SAR442168, which was in Phase IIb for multiple sclerosis. Principia’s lead compound was rilzabrutinib, which was in Phase III for pemphigus.

Deal Date: Oct 26, 2020

Deal Value: $4B

Bayer acquired Asklepios BioPharmaceutical for $4B. The acquisition strengthens Bayer’s cell and gene therapy portfolio with the addition of AskBio’s AAV technology platform, CDMO facilities, and preclinical and clinical compounds for neuromuscular, CNS, cardiovascular, and metabolic diseases. Its leading gene therapy is in Phase I/II for Pompe disease. This also complements Bayer’s 2019 acquisition of BlueRock Therapeutics. Asklepios is eligible to receive 75% of the milestone payments in the next five years.

Deal Date: Mar 2, 2020

Deal Value: $4.9B

Gilead acquired Forty-Seven with its lead product magrolimab, a monoclonal antibody targeting CD47 in Phase Ib for acute myeloid leukemia (AML). The company is also studying myelodysplastic syndrome (MDS) and diffuse large B-cell lymphoma (DLBCL). The acquisition strengthens Gilead’s oncology portfolio. Forty-Seven received $4.9B at $95.50 per share at a premium of 65%.

Deal Date: Aug 19, 2020

Deal Value: $6.5B     

Johnson & Johnson acquired Momenta Pharmaceuticals for $6.5B at $52.50 per share at a premium of 79%. The acquisition strengthens Johnson & Johnson’s portfolio of autoimmune disease therapies with Phase III nipocalimab (M281), an anti-FcRn antibody for warm autoimmune hemolytic anemia, which is also in Phase II for myasthenia gravis among other indications. Momenta’s potential pipeline may have indications in maternal-fetal disorders, neuro-inflammatory disorders, rheumatology, dermatology, and autoimmune hematology. Nipocalimab recently received a rare pediatric disease designation.

Deal Date: Oct 05, 2020

Deal Value: $13.1B 

Bristol Myers Squibb acquired MyoKardia for $13.1B at $225 per share at a 1-day premium of 61%. MyoKardia’s mavacamten, a small molecule in Phase III for obstructive hypertrophic cardiomyopathy (HCM), has an NDA submission expected in Q1 2021 and is in Phase II for Non-obstructive Hypertrophic Cardiomyopathy. MyoKardia also has 2 clinical compounds, danicamtiv (MYK-491) in Phase II for genetic dilated cardiomyopathy, systolic dysfunction, and atrial fibrillation, and MYK-224, a Phase I small molecule for hypertrophic cardiomyopathy.

Deal Date: Sep 13, 2020

Deal Value: $21B

Gilead acquired Immunomedics for $21B at $88.00 per share at a premium of 108%. The acquisition gives Gilead trodelvy, an antibody-drug conjugate approved for mTNBC. Trodelvy (sacituzumab govitecan-hziy) is a Trop-2 directed ADC, which received accelerated approval for mTNBC in the US. Trodelvy is also being studied in Phase III for 3L HR+/HER2- breast cancer and Phase II for bladder cancer, NSCLC, and other solid tumors.

Deal Date: Dec 12, 2020

Deal Value: $39B     

AstraZeneca acquired Alexion for $39B including its drugs Soliris, Ultomiris, and 11 pipeline molecules in 20 different clinical programs. Soliris is an anti-complement component 5 mAb approved for paroxysmal nocturnal haemoglobinuria, atypical haemolytic uremic syndrome, generalized myasthenia gravis, and neuromyelitis optica spectrum disorder and is in Phase III for Guillain-Barre syndrome. Ultomiris is an approved antibody for Paroxysmal nocturnal hemoglobinuria and Hemolytic uremic syndrome and is in Phase III for generalized Myasthenia gravis, neuromyelitis optica spectrum disorder (NOSMD), hematopoietic stem cell transplant-associated thrombotic microangiopathy, Amyotrophic lateral sclerosis, complement-mediated thrombotic microangiopathy, severe pneumonia or acute respiratory distress syndrome in COVID-19. Alexion’s expertise in the complement cascade beyond C5 and additional modalities, including the pathway of the complement system, will strengthen AstraZeneca’s portfolio including immunology, neurology, metabolic cardiovascular, nephrology, and rare disease. Alexion shareholders received $60 per share in cash and 2.1243 ADS shares of AstraZeneca valued at $175 per share at a premium of 45%, or approximately $39B. Upon completion, Alexion will own 15% of the combined company.

The post Top 20 Biopharma M&A of 2020 by Total Deal Value first appeared on PharmaShots.

Roche set to file ophthalmology drug faricimab in DME

Roche looks set to mount a challenge to Bayer’s ophthalmology drug Eylea in 2021 after its faricimab antibody showed comparable results in diabetic macular oedema (DME) but with half the injections, in twin phase 3 studies.

While Eylea (aflibercept) is taken in doses eight weeks apart, results from the YOSEMITE and RHINE studies showed faricimab produces a similar effect but with a 16-week dosing regimen.

Roche’s approach is similar to that taken by Novartis with its ophthalmology drug Beovu (brolucizumab), which can be taken three months apart by some patients in wet age-related macular degeneration, another indication where Eylea is well established.

Roche’s two non-inferiority trials met their main goals, showing that that faricimab given every eight weeks and at personalised dosing intervals of up to 16 weeks gave similar visual acuity gains compared with Eylea given every eight weeks.

Faricimab was generally well-tolerated, with no new safety signals identified, Roche said.

The studies each have three treatment arms, with participants randomised to receive either faricimab or aflibercept at fixed eight-week intervals, or faricimab at personalised intervals of up to 16 weeks, following a loading phase.

In a secondary endpoint, across both studies, more than half of participants in the faricimab personalised dosing arms achieved an extended time between treatments of 16 weeks at year one.

This is the first time any investigational medicine has achieved this level of durability in a phase 3 study of people with DME, Roche noted.

Faricimab also has different mechanism of action compared with Eylea and is the first bispecific antibody designed especially for the eye.

It targets two pathways – via angiopoietin-2 (Ang-2) and VEGF-A – that drive a number of retinal conditions, including DME.

Roche is also testing the long-term safety and tolerability of faricimab in DME in the phase 3 Rhone-X study.

Detailed results of YOSEMITE and RHINE will be presented at the Angiogenesis, Exudation and Degeneration 2021 medical conference in Miami next month, and filed with regulators around the world.

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PharmaShots’ Most Read News of 2020

“Lockdown’ declared Collins Dictionary word of the year. The year 2020, well known as COVID-19 year has been a busy year for global pharma and biotech companies involved in M&A, option & licensing agreements, and gaining approvals. Our team has compiled a list of 30 most read life sciences news on PharmaShots in 2020.

1. Bayer Signs an Exclusive Option to License Agreement with Dare Biosciences to Commercialize Ovaprene in the US

  • Dare to receive up front, $20M as option exercise fee, $310M as commercial milestones, royalties on sales of the product along with access to Bayer’s clinical and market capabilities and remain responsible for development & regulatory activities of Ovaprene
  • Bayer to get exclusive right to commercialize Ovaprene in the US, once approved by the FDA. Dare is expected to file IDE for the therapy in H1’20 and the initiation of its clinical study in H2’20 following FDA’s review and clearance of the IDE
  • Ovaprene is an investigational hormone-free monthly vaginal contraceptive, currently in development for the prevention of pregnancy and if approved, will be the first monthly non-hormonal contraceptive therapy

2. Theramex to Acquire Commercial Rights of MSD’s Zoely to Expand its Footprints

  • Theramax acquires commercialization rights of Zoely, allowing it to commercialize the therapy in 50+ countries globally. Earlier, Theramax has right to commercialize Zoely in eleven countries in the EU while MSD retains rights in the US and Canada
  • The acquisition of further rights of Zoely expands Theramex global footprints by providing innovative therapies to maintain the healthcare of women
  • Zoely is a combined oral contraceptive therapy consisting of two steroid hormones: 17-beta estradiol and nomegestrol acetate

3. Gilead Signs an Exclusive License Agreement with Rockefeller University for its Portfolio of HIV Abs

  • Rockfeller to receive up front, milestones plus royalties on sales and will retain rights to perform non-clinical and early-stage clinical research on the portfolio of HIV Abs. Gilead to get exclusive rights to develop and commercialize Rockefeller’s full portfolio of HIV bNAbs
  • The focus of the agreement is to enhance Gilead’s HIV pipeline and will advance academic programs into potential future products
  • 3BNC117 and 10-1074 are clinical-stage products with the ability to be used as HIV long-acting therapies for treatment and prevention

4. Fujifilm’s CAD EYE Receives CE Mark to Support the Detection of Colonic Polyp Utilizing AI in the EU

  • Fujifilm’s CAD EYE receives CE mark, backing the real-time detection of colonic polyps during colonoscopy utilizing AI, will be available with software EW10-EC01 and the compatible expansion unit EX-1 in combination with the ELUXEO 7000 system
  • CAD EYE utilizes FUJIFILM’s REiLi AI technology and can perform complex segmentation of 2D/3D images, spot lesions & is compatible with various imaging modalities. It automatically engages with white light or LCI mode to improve the accuracy of lesion detection
  • CAD EYE is customized detection support used with the ELUXEO system, aimed to improve lesion detection in the colon at the expert level and is expected to be available with EX-1 in Mar’2020

5. GSK Reports the Acceptance of EMA’s MAA for Zejula (niraparib) as 1L Maintenance Treatment for Platinum-Responsive Advanced Ovarian Cancer

  • The EMA has accepted Type II Variation (T2V) for Zejula as maintenance therapy in a 1L setting for women with advanced platinum-responsive advanced OC, regardless of biomarker status. The validation indicates the acceptance of MAA and the initiation of CHMP’s formal review process
  • The submission is based on P-III PRIMA study assessing Zejula vs PBO in women in a ratio (2:1) as 1L therapy for stage III/ IV platinum-responsive advanced OC. The study demonstrated clinical outcomes of Zejula
  • Zejula (PO, qd) is a PARP inhibitor, indicated as a monothx. for the maintenance treatment of patients with platinum‑sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response to platinum-based CT

6. Esperion’s Nexlizet (bempedoic acid and ezetimibe) Tablet Receives the US FDA’s Approval as LDL-Cholesterol Lowering Medicine

  • The approval is based on P-III trial Fixed Combination Drug Product LDL-C Lowering program, involves assessing of Nexlizet vs PBO when added on to maximally tolerated statins
  • The study resulted in well-tolerated data and lowered LDL-C by 38%, when added on to maximally tolerated statins. Also, the results are published in The European Journal of Preventative Cardiology
  • Nexlizet is an oral qd, non-statin LDL-cholesterol lowering medicine approved by the US FDA on Feb 21, 2020 and will be available in Jul 2020. Nexletol (bempedoic acid) is a novel ATP Citrate Lyase inhibitor involves lowering of LDL-C by cholesterol biosynthesis and up-regulating the LDL receptors, will be available from Mar 30, 2020

7. AstraZeneca Reports Results of Imfinzi + Tremelimumab in P-III CASPIAN Study as 1L Treatment for Extensive-Stage Small Cell Lung Cancer

  • The P-III CASPIAN study involves assessing of Imfinzi + SOC (etoposide and carboplatin/ cisplatin CT) or Imfinzi + Tremelimumab vs CT as monothx. as a 1L treatment for 805 patients with ES-SCLC in 200+ centers across 23 countries
  • The first arm (Imfinzi + SOC) has met its 1EPs of OS in Jun’2019 while the second arm (Imfinzi + tremelimumab) did not meet its 1EPs of OS. The safety profile of each therapy is consistent with the known safety profiles
  • Imfinzi (durvalumab) is mAb targeting PD-L1, acts by blocking the interaction of PD-L1 with PD-1 & CD80 and is currently under review in combination with etoposide and carboplatin/cisplatin as 1L treatment for ES-SCLC in the US, EU and Japan with its anticipated PDUFA date in 2021

8. Novo Nordisk’s Fiasp (insulin aspart injection) Receives Health Canada’s Approval for Children with Diabetes

  • Health Canada has expanded the approval of Fiasp (10mL vials) to include use in insulin infusion pumps for the improvement of glycemic control in pediatric patients aged ≥2yrs with diabetes (T1D/T2D both)
  • The approval is based on data from 7 clinical studies that verified the safety & efficacy of Fiasp in children. The label change for use in insulin infusion pumps is based on Health Canada’s review of data from 5 clinical studies which demonstrated the efficacy of Fiasp used in insulin infusion pumps in adults with diabetes
  • Fiasp is the first and only fast-acting mealtime insulin injection, administered at the beginning of a meal or within 20 minutes after starting a meal and has received FDA’s approval as an IV infusion or SC MDI in adults with diabetes

9. Merck KGaA’s ERBITUX (cetuximab) Receives NMPA’s Approval as a 1L treatment for Recurrent/ Metastatic Squamous Cell Carcinoma of the Head and Neck

  • The approval is based on P-III CHANGE II study assessing extreme regimen (ERBITUX + cisplatin + 5-FU, followed by ERBITUX as maintenance therapy) vs Pt. based CT (cisplatin + 5-FU) in 243 patients aged ≥18 yrs. with R/M SCCHN, prior not treated with any systemic therapy in China
  • The P-III CHANGE II study results: improvement in PFS (5.5 vs 4.2mos.); OS (10.2 vs 8.4mos.), ORR (50% vs 27%) with no new safety findings
  • ERBITUX is an IgG1 mAb targeting the EGFR and is an approved therapy in 100+ countries for RAS wild-type m-CRC and for HNSCC

10. Bausch Health to Initiate Clinical Study Evaluating Virazole (Ribavirin for Inhalation Solution, USP) in Patients with COVID-19 in Canada

  • The clinical study will evaluate the safety and efficacy of Virazole + SOC in hospitalized patients aged ≥18yrs. with respiratory distress due to COVID-19
  • The clinical study has been approved by Health Canada and is expected to initiate within the next few weeks. The company is working with multiple health authorities including the US FDA regarding additional studies to assess Virazole as a treatment for COVID-19 infection
  • Virazole (ribavirin for inhalation solution, USP) aerosol is indicated only for lower respiratory tract infection due to RSV. The Bausch Foundation is working with health authorities in Italy to make Virazole for inhalation available free of charge in compassionate use in hospitals

11. Amgen Signs a Partnership with Adaptive Biotechnologies to Develop Abs for COVID-19

  • Adaptive to expand its platform for selection of B cell receptors of recovered patients from COVID-19. Amgen will utilize its Ab engineering and drug development capabilities to select and develop Abs designed to bind and neutralize SARS-CoV-2. Additionally, Amgen ‘s subsidiary DeCODE Genetics located in Iceland, will provide genetic information from patients infected with COVID-19
  • The focus of the collaboration is to combine expertise to discover and develop fully human neutralizing Abs for SARS-CoV-2 virus to treat COVID-19 where Adaptive’s immunological medicine platform will help in identification of virus neutralizing Abs
  • Additionally, the Abs can be used to treat patients with COVID-19 and can be administered to patients with who are at increased risk of exposure to SARS-CoV-2

12. BioNTech and Pfizer Complete Dosing of BNT162 in First Cohort of P-I/II Study in Germany

  • The companies reported that the first cohort of BioNTech’s P-I/II clinical trial has dosed 12 participants with BNT162 in Germany since dosing began on Apr 23, 2020. Following the regulatory approvals, both the companies plan to initiate the clinical study for BNT162 in the US
  • The dose-escalation portion of the P-I/II study will include ~200 healthy participants aged 18-55yrs. and will target a dose range of 1-100 µg, focusing on determining the optimal dose for further studies and to evaluate the safety and immunogenicity of the vaccine
  • The study will evaluate the effects of repeated vaccination following a prime injection for 3 vaccine candidates that contain uRNA or modRNA. The fourth vaccine candidate contains saRNA will be evaluated following a single dose of vaccine. Additionally, BioNTech is collaborating with Fosun Pharma to develop BNT162 in China, where the companies expect to conduct clinical studies

13. Fresenius Kabi Signs an Agreement with Medec to Commercialize IDACIO (adalimumab, biosimilar) in Germany

  • Fresenius Kabi and Medec collaborated to offer IDACIO as an additional therapy option for rheumatologists and dermatologists to treat rheumatic illnesses. From Jun 01, 2020, Medec’s will market the biosimilar therapy
  • Last year, Fresenius Kabi launched IDACIO in the EU for arthritis and psoriasis. The collaboration offers patients and doctors new benefits and synergies in therapy offerings as well as consulting
  • Medac provides methotrexate (metex PEN, metex FS) as the parenteral treatment of patients with chronic inflammatory diseases, the affected patients are treated with a combination of methotrexate and adalimumab

14. Neurocrine Biosciences Exercises its Option with Idorsia for ACT-709478

  • Idorsia to receive $45M upfront in cash, $365M for development & regulatory milestone, one-time sales threshold and royalties on sales. Additionally, will receive $7M in funding to discover, identify and develop additional novel T-type calcium channel blockers
  • Neurocrine exercises its option to license rights for ACT-709478 (post IND acceptance from the US FDA on Apr 30, 2020) for rare pediatric epilepsy. In 2019, Neurocrine and Idorsia signed a preclinical research collaboraion for ACT-709478 to treat rare pediatric epilepsy
  • ACT-709478 is an selective, orally-active and brain penetrating T-type calcium channel blocker also received the US FDA’s Rare Pediatric Disease designation for rare pediatric epilepsy with completion of P-I in 2019 and expected P-II initiation in in H2’20

15. Moderna Signs a Ten-Year Worldwide Agreement with Lonza to Manufacture mRNA-1273 Against COVID-19

  • The companies intend to establish manufacturing suites at Lonza’s facilities in the US and Switzerland to manufacture mRNA-1273 at both sites. The collaboration will deploy Lonza’s global expertise in technology transfer and manufacturing while the technology transfer expected to begin in Jun’2020
  • The focus of the collaboration is to enable the manufacturing of mRNA-1273 up to 1B doses/year and anticipates the manufacturing of the first batches of mRNA-1273 at Lonza US site in Jul’2020, assuming the currently expected dose of 50µg
  • Manufacturing operations at Lonza US site is covered by Moderna’s agreement with BARDA under which BARDA will support late-stage clinical development programs of mRNA-1273. On Apr 27, 2020, Moderna has submitted IND to the US FDA for P-II studies with its expected initiation in Q2’20

16. Roche’s Enspryng (satralizumab) Receives MHLW’s Approval for Neuromyelitis Optica Spectrum Disorder in Japan

  • The approval is based on two P-III SAkuraStar & SAkuraSky studies involve assessing Enspryng (120mg, SC, q4w) as a monothx & as an add-on therapy to baseline IST vs PBO in 95 & 83 patients aged 20-70 & 13-73yrs. in a ratio (2:1) & (1:1) administered at week 0,2 & 4 in patients with NMOSD respectively
  • In overall population: reduction in the risk of relapse (62% & 55%); In the pre-specified subgroup of AQP4-IgG seropositive patients: reduction in the risk of relapse (79% & 74%) respectively
  • Enspryng is a mAb targeting IL-6 and is under PR in Canada for NMOSD patients who are AQP4-IgG seropositive. In Oct’2019, the FDA & EMA has accepted the MAA for the therapy with expected CHMP & FDA’s decision in 2020

17. Cipla Launches Cipremi (remdesivir lyophilized powder for injection 100 mg) to Treat Patients with Severe COVID-19

  • The US FDA has issued a EUA to Gilead for emergency use of remdesivir to treat hospitalized COVID-19 patients. In May, Gilead has extended a voluntary non-exclusive license to Cipla to manufacture and market Cipla’s Remedisvir called CIPREMI
  • Cipla has received DCGI’s approval for restricted emergency use in India as part of the accelerated approval process. Cipla will provide training on the use of the drug, informed patient consent documents, conduct post-marketing surveillance as well as to conduct a P-IV clinical trial on Indian patients
  • As per ACTT-1 study, 1063 patients were treated with Remdesivir vs PBO over 60 centers across the US, EU and Asia demonstrated faster time to clinical recovery in hospitalized patients with the mortality rate as (7.1% vs 11.9%)

18. Sorrento Submits EUA to the US FDA for its COVI-TRACK Test to Detect COVID-19

  • Sorrento has reported that its EUA is under review at the US FDA for its COVI-TRACK in vitro diagnostic test kit for the detection of IgG and IgM Abs in sera of patients exposed to the SARS-CoV-2 virus
  • Following the issuance of an EUA, the COVI-TRACK test will be available for distribution to clinical testing sites nationwide. The assay develops three clear lines that confirm the assay validity and the qualitative detection & differentiation of IgM and IgG Abs to the COVID-19
  • Sorrento has secured manufacturing capacity to ramp up the production of up to 5M test kits/ month with the availability of results in ≤8mins. The assay showed specificity > 97% and diagnostic sensitivity of > 94% in an analytical validation

19. Dr. Reddy’s and GRA Collaborate with Fujifilm for Avigan (favipiravir) to Treat COVID-19 Outside the Japan

  •  Fujifilm to receive upfront, license fee along with royalties on sales of the therapy. Dr. Reddy’s and GRA to get the exclusive right to develop & commercialize Avigan globally (Ex- Japan). Additionally, Dr. Reddy’s would have exclusive rights for the therapy in India
  • Fujifilm will provide pre/ clinical data of Avigan to Dr. Reddy’s and GRA for utilizing it in clinical studies targeting COVID-19. Moreover, Dr. Reddy’s will get right to use Avigan’s patents of formulation and manufacturing method and will establish a setup for developing drug-like Avigan and utilizes the GRA’s global sales network to supply the manufactured drugs
  • Fujifilm is currently conducting a clinical study on Avigan targeting COVID-19 patients in the US and Japan and is collaborating with multiple companies to increase the drug’s production

20. ViiV Healthcare’s Rukobia (fostemsavir) Receives the US FDA’s Approval for HIV in Patients with Limited Treatment Options

  • The approval is based on P-III BRIGHTE study assessing Rukobia (600mg, ER) + OBT in 371 HTE adults living with multidrug-resistant HIV. Participants were enrolled in either a randomized or nonrandomized cohort
  • In the randomized cohort, 60% adults achieved undetectable HIV viral load and clinically meaningful improvements to CD4+ T-cell count @96wks., HIV-1 RNA <40 copies/mL @24 & 96wks. (53% & 60%); changes in CD4+ cell count (90 & 205 cells/mm3) respectively
  • In the nonrandomized cohort, 37% achieved HIV-1 RNA <40 copies/mL @24 & 96wks.; HIV-1 RNA <200 copies/mL (42% & 39%); mean changes in CD4+ cell count (41 & 119 cells/mm3) respectively. Fostemsavir is a first-in-class HIV-1 attachment inhibitor, currently under EMA’s review with additional submissions to regulatory authorities anticipated in 2020 & 2021

21. Zydus Launches Cheapest Version of Remdesivir at $37.41 per Vial in India

  • The company has launched Remdec at a price of $37.41 (Rs. 2800) for a 100mg lyophilized injection. The generic version is the most economical Remdesivir brand in India
  • In Jun’2020, Zydus signed a non-exclusive agreement with Gilead to manufacture and commercialize Remdesivir for severe COVID-19 in India. The API of the therapy has been developed and manufactured at the group’s API manufacturing facilities in Gujarat
  • The drug will be made available across India via Zydus’ strong distribution chain reaching out to government and private hospitals treating COVID patient

22. Johnson & Johnson to Acquire Momenta Pharmaceuticals for $6.5B

  • J&J acquires Momenta in all-cash transaction at a price of $52.50/ share, making a total deal value as $6.5B. The transaction is expected to be closed in H2’20
  • The acquisition allows J&J to expand its portfolio for autoimmune diseases with the addition of Momenta’s Nipocalimab (M281) to its pipeline. In addition to nipocalimab, Janssen will acquire Momenta’s pipeline of clinical and pre-clinical assets
  • Janssen plans to retain Momenta’s presence in Cambridge, Massachusetts which will increase J&J footprint and capabilities in the key innovation hub. Nipocalimab provides an opportunity for Janssen to deliver transformative treatments in autoantibody-driven autoimmune diseases

23.  Novartis’ Beovu (brolucizumab) Receives EMA’s Approval for its Safety Label Update to Treat Wet Age-Related Macular Degeneration

  • The EU label update includes additional categorization of retinal vasculitis and/or retinal vascular occlusion, usually in the intraocular inflammation. The approval follows Novartis completion of safety review and initiation of an update to the Beovu prescribing information globally
  • The label update is applicable to all 27 EU member states as well as UK, Iceland, Norway, and Liechtenstein. Beovu is now approved for wet AMD treatment in 40+ countries including in the US, EU, UK, Japan, Canada, and Australia
  • Beovu (brolucizumab) is the clinically advanced humanized single-chain Ab fragment (scFv) that enhances tissue penetration, rapid clearance from the systemic circulation, and drug delivery characteristics. Novartis has established a multidisciplinary panel of internal experts collaborating with external advisors to examine the root cause, potential risk factors, and mitigation of AEs

24. Boehringer Ingelheim Initiates P-II Study of BI 764198 for Patients with Severe Respiratory Illness from COVID-19

  • The P-II trial will assess BI 764198 (qd for ~4wks.) in patients hospitalized for COVID-19 with expected enrollment initiation in Oct’2020. The 1EPs will be the percentage of patients who are alive and free of mechanical ventilation at day 29 of treatment while other EPs include clinical improvement, oxygen saturation & ICU admission
  • The therapy has shown a reduction in cellular damage and lung edema in preclinical studies and may provide similar benefits in patients with severe SARS-CoV-2 infection. BI 764198 was well tolerated in P-I study in healthy adults
  • BI 764198 is potent & selective inhibitor of TRPC6, focusing to reduce the need for ventilator support and to improve patient recovery rate

25. Roche’s Tecentriq in Combination with Avastin Receives China NMPA’s Approval for the treatment of Unresectable Hepatocellular Carcinoma

  • The approval was based on the P-III IMbrave150 study (n=501) assessing the combination of Tecentriq (1200 mg, IV) and Avastin (15 mg/kg, IV) or sorafenib (400 mg, bid) in unresectable HCC patients who had not received prior systemic therapy which included analyses of a cohort of Chinese patients (n=194) from the same study
  • Results: Tecentriq in combination with Avastin reduced the risk of OS by 56% (among Chinese patients) and 42% (global results) & the PFS risk by 40% (among Chinese patients) and 41% (global results) as compared with sorafenib
  • IMbrave150 is the 1st P-III cancer immunotherapy study to show an improvement in OS and PFS in people with unresectable or metastatic HCC compared with sorafenib. Additionally. in May 2020, the US FDA approved Tecentriq in combination with Avastin for the treatment of people with unresectable or metastatic HCC who have not received prior systemic therapy

26. Sanofi Entered into an Agreement with Merck to Conduct a P-II Study of THOR-707 in Sequenced Administration with MSD’s Keytruda (pembrolizumab) in Patients with Various Cancers

  • Sanofi will sponsor the clinical trials while MSD will provide KEYTRUDA. Additionally, Sanofi is separately evaluating the activity of THOR-707 in combination with other anti-PD-1 antibodies, including Libtayo (cemiplimab-rwlc) and with anti-EGFR and anti-CD38 antibodies for various types of cancer tumors
  • In preclinical studies, THOR-707 demonstrated the ability to induce the expansion of CD8+T-cells resulting in anti-tumor effects both as a single agent as well as in combination with an anti-PD1 mAb
  • THOR-707 is currently being evaluated by Sanofi in an ongoing P-I dose escalation and expansion trial assessing THOR-707 and determining its recommended P-II dose alone and in combination with anti-PD-1 and anti-EGFR antibodies

27. AstraZeneca and Fusion Collaborate to Develop and Commercialize Radiopharmaceuticals and Combination Therapies for Cancer

  • Fusion to receive up front, as well as development milestones and other payments. The companies will jointly discover, develop, and have an option to co-commercialize novel TATs in the US while AstraZeneca will lead commercialization in the ROW with equal profit & loss sharing globally
  • The collaboration leverages Fusion’s TAT platform and expertise in radiopharmaceuticals with AstraZeneca’s leading portfolio of Abs and cancer therapies, including DDRis
  • Additionally, the companies will exclusively explore certain specified combination strategies between TATs (including Fusion’s FPI-1434) and AstraZeneca’s therapies for the treatment of multiple cancers. Both companies will retain full rights to their respective assets

28. Lucira’s All-In-One Test Kit Receives the US FDA’s EUA as the First COVID-19 Test for Self-Testing at Home

  • The Lucira’s COVID-19 all-in-one test kit test has been authorized for home use with self-collected nasal swab samples in individuals aged≥ 14yrs. who are suspected of COVID-19 by their HCPs
  • It is also authorized for use in POC settings for all ages, but samples must be collected by an HCP when the test is used at the POC to test individuals <14yrs. The test is currently authorized for prescription use only
  • Lucira plans to amend its EUA or file a new EUA so people who think they’re infected with COVID-19 can communicate with a medical professional online through a website to arrange a prescription and overnight delivery of the test kit by Q2’21

29. UCB Acquires Handl Therapeutics to Augment its Gene Therapy Portfolio

  • The acquisition will bolster UCB’s pipeline program, capabilities, and platforms in the gene therapy space. The Handl Therapeutics will continue to be based in Leuven, Belgium while working closely with UCB’s international research teams
  • In addition, the UCB collaborated with Lacerta to focus on CNS diseases, under which Lacera will lead research, preclinical activities, and the early manufacturing process development, while UCB will complete IND-enabling studies, manufacturing, and clinical development
  • The collaboration will allow UCB to access Lacerta’s expertise in AAV-based CNS targeted gene therapies, fortifying UCB’s ability to produce effective treatments for neurodegenerative diseases

30. Janssen Acquires Rights to Hemera’s HMR59 for Late-Stage Age-Related Macular Degeneration

  • Janssen acquires rights to Hemera’s HMR59, administered as a one-time, outpatient, IVT inj. to help preserve vision in patients with geographic atrophy
  • The acquisition will boost Janssen’s eye disease portfolio & strengthens its gene therapy capabilities
  • HMR59 is designed to increase the ability of retina cells to make a soluble form of CD59, helping to prevent further damage to the retina and preserve vision. The P-I study of the therapy for patients with geographic atrophy is completed while the P-I study exploring HMR59 in patients with wet-AMD is currently conducting follow-up visits to evaluate the long-term safety

Related Post: PharmaShots’ Most Read News of 2019

The post PharmaShots’ Most Read News of 2020 first appeared on PharmaShots.

INVEST Precision Medicine Pitch Perfect winner spotlight: TrialSpark

Judges picked TrialSpark as the winner on the life sciences track of the pitch competition at MedCity’s virtual precision medicine conference. While the company is focused on improving clinical trials for others, it hopes eventually to bring drugs of its own to market.

FDA rejects Novartis’ cholesterol drug after factory inspection issue

Novartis’ cholesterol drug inclisiran has hit a speed bump with the FDA, which has rejected the potential blockbuster because a manufacturing facility has yet to be inspected.

Matters appear to have been complicated by the pandemic and the travel disruption that it has caused, which is preventing an FDA team from visiting the plant in Europe.

In a statement the Swiss pharma said that the FDA has not raised any concerns about the safety or efficacy of the drug, which Novartis added to its pipeline after buying The Medicines Company for $9.7 billion late last year.

A first-in-class treatment discovered by Alnylam and then licensed to The Medicines Company, the drug is being developed for treatment for hyperlipidaemia in adults who have elevated low-density lipoprotein cholesterol (LDL-C) while being on a maximum tolerated dose of a statin therapy.

The FDA was due to make a regulatory decision on inclisiran by Wednesday but this has been delayed because of the unresolved “facility inspection-related conditions”.

Novartis said it will receive these requirements at the European manufacturing facility within 10 business days.

The FDA has not yet conducted a facility inspection and the FDA will set out a schedule if it deems one necessary, once safe travel may resume.

The European Commission has already approved the drug under the brand name Leqvio earlier this month following backing from the CHMP regulatory committee.

Inclisiran is a small interfering RNA (siRNA) therapy that works by inhibiting PCSK9 – the same target as Amgen’s Repatha (evolocumab) and Sanofi/Regeneron’s Repatha (alirocumab) – but is dosed only twice a year rather than every month.

Novartis hopes that the drug will make an impact where these antibody drugs have failed, with Repatha and Praluent lacking sales momentum despite being on the market for more than five years.

Payers had deemed the drugs to be too expensive and even price cuts failed to expand their use.

In January, Novartis and NHS England forged a pact to accelerate access to inclisiran for primary prevention of cardiovascular disease.

The post FDA rejects Novartis’ cholesterol drug after factory inspection issue appeared first on .

PharmaShots Weekly Snapshots (Dec 14-18, 2020)

Sandoz to Launch Hyrimoz (biosimilar, adalimumab) in Canada

Published: Dec 17, 2020 | Tags: Authorization, Biosimilar, canada, health, Humira, Hyrimoz, Launch, receives, Sandoz

Amgen’s Riabni (biosimilar, rituximab) Receives the US FDA’s Approval for Multiple Diseases

Published: Dec 17, 2020 | Tags: Adult, Amgen, approval, Biosimilar, CLL, GPA, MPA, NHL, patients, receives, RIABNI, Rituxan, Rituximab, rituximab-arrx, Us FDA

NOWDiagnostics Receives CE Mark for its ADEXUSDx COVID-19 Antibody Fingerstick Test

Published: Dec 17, 2020 | Tags: ADEXUSDx COVID-19, Antibody Fingerstick Test, COVID-19, Launches, NOWDiagnostics

GSK’s Benlysta (belimumab) Receives the US FDA’s Approval as the First Therapy for Active Lupus Nephritis (LN)

Published: Dec 17, 2020 | Tags: (belimumab), Active, Benlysta, GSK, Lupus Nephritis (LN), Recieves, US, US FDA’s Approval

GSK Signs an Exclusive License Agreement with Surface Oncology to Develop and Commercialize SRF813

Published: Dec 17, 2020 | Tags: Commercialize, Develop, Exclusive License Agreement, GSK, Signs, SRF813, Surface Oncology

Moderna’s mRNA-1273 Receives the US FDA’s Advisory Committee Vote Supporting EUA Against COVID-19

Published: Dec 17, 2020 | Tags: Advisory, Against, Committee, COVID-19, EUA, Moderna, receives, Supporting, US, Us FDA, vaccine, Vote

Novartis to Acquire Cadent Therapeutics for ~$770M

Published: Dec 17, 2020 | Tags: $770M, Acquire, Cadent, Novartis, therapeutics

Kite’s Tecartus (KTE-X19) Receives EC’s Conditional Marketing Authorization for R/R Mantle Cell Lymphoma

Published: Dec 16, 2020 | Tags: (KTE-X19), EC’s Conditional Marketing Authorization, Europe, Kite, receives, Relapsed or Refractory Mantle Cell Lymphoma, Tecartus, ZUMA-2 Study

Amgen Reports NDA Submission of Sotorasib to the US FDA for Advanced/Metastatic NSCLC With KRAS G12C Mutation

Published: Dec 16, 2020 | Tags: Advanced, Amgen, KRAS G12C, Metastatic, Mutation, NDA, NSCLC, reports, Sotorasib, Submission, Us FDA

Novartis’s Zolgensma Receives Health Canada Approval as the One-Time Gene Therapy for Pediatric Patients with SMA

Published: Dec 16, 2020 | Tags: approval, Health Canada, Novartis, One-Time Gene Therapy, receives, Spinal Muscular Atrophy (SMA), Zolgensma

Novo Nordisk to Initiate a P-lll Study of Semaglutide to Treat Alzheimer Disease

Published: Dec 16, 2020 | Tags:  Alzheimer Disease, Novo Nordisk, P-lll Development, Semaglutide, Start

Novartis’s Entresto Receives the US FDA’s Advisory Committee Recommendation to Treat Patients with HFpEF

Published: Dec 15, 2020 | Tags: Advisory, Committee, Entresto, HFpEF, Novartis, patients, Positive, receives, Recommendation, Treat, USFDA

Abbott’s COVID-19 IgG Quantitative Antibody Blood Test Receives CE Mark

Published: Dec 15, 2020 | Tags: Abbott, antibody, Blood, CE Mark, COVID-19, IgG, Quantitative, receives, Test

Ellume’s COVID-19 Home Test Receives the US FDA’s EUA as First Over-the-Counter Diagnostic Test

Published: Dec 15, 2020 | Tags: Antigen, COVID-19, Ellume, EUA, receives, Test, Us FDA

Bone Health’s OsteoBoost Vibration Belt Receives the US FDA’s Breakthrough Device Designation for Osteoporosis

Published: Dec 15, 2020 | Tags: Belt, Bone Health Technologies, Breakthrough, Designation, Device, OsteoBoost, receives, USFDA, Vibration

Takeda Reports the US FDA’s Acceptance of NDA for TAK-721 (budesonide oral suspension) to Treat Eosinophilic Esophagitis

Published: Dec 15, 2020 | Tags: (budesonide oral suspension), Eosinophilic Esophagitis (EoE), NDA, reports, TAK-721, Takeda, US FDA’s Acceptance

Athenex’s Klisyri (tirbanibulin) Receives the US FDA’s Approval for Actinic Keratosis on the Face or Scalp

Published: Dec 15, 2020 | Tags: (tirbanibulin), Actinic Keratosis, Athenex’s, Face, Klisyri, receives, Scalp, US FDA’s Approval

Gilead Amends Agreement with Galapagos for Development and Commercialization of Jyseleca (filgotinib)

Published: Dec 15, 2020 | Tags: Agreement, Commercialization, Development, Filgotinib, Galapagos, Gilead, Jyseleca, Signs

Lilly to Acquire Prevail Therapeutics for ~$1.04B

Published: Dec 15, 2020 | Tags: ~$1.04B, Acquire, Lilly, Prevail Therapeutics

EMA’s CHMP Recommends Four-Week Dosing Option for AstraZeneca’s Imfinzi to Treat Unresectable NSCLC

Published: Dec 15, 2020 | Tags: approval, AstraZeneca, CHMP, EU, Imfinzi, NSCLC, Recommended, Unresectable

CureVac Commences P-llb/lll Trial of CVnCoV for COVID-19

Published: Dec 14, 2020 | Tags: Commences, COVID-19, CureVac, CVnCoV, P-llb/lll Trial

Roche Launches Cobas PIK3CA Mutation Test for Patients with Advanced or Metastatic Breast Cancer

Published: Dec 15, 2020 | Tags: Advanced, breast, Cancer, Cobas, Launch, Metastatic, Mutation, patients, PIK3CA, Roche, Test

Samsung Bioepis Initiates P-Ill Study of SB16 Proposed Biosimilar to Prolia (denosumab)

Published: Dec 14, 2020 | Tags: (Denosumab), Initiates, P-Ill Study, Prolia, Proposed Biosimilar, Samsung Bioepis, SB16

Genentech Signs a Worldwide License Agreement with Relay Therapeutics to Develop and Commercialize RLY-1971

Published: Dec 14, 2020 | Tags: Agreement, Commercialization, Develop, Genentech, Relay Therapeutics, RLY-1971, Signs, Worldwide License

Genentech’s Ocrevus Shorter 2-Hour Infusion Receives the US FDA’s Approval for Relapsing & Primary Progressive Multiple Sclerosis

Published: Dec 14, 2020 | Tags: approval, Genentech, Multiple Sclerosis, ocrelizumab, Ocrevus, Primary, Progressive, receives, Relapsing, Us FDA

Daiichi Sankyo and AZ’s Trastuzumab Deruxtecan Receives CHMP’s Recommendation for Approval to Treat HER2 Positive Metastatic Breast Cancer

Published: Dec 11, 2020 | Tags: approval, AstraZeneca, breast, Cancer, CHMP, Daiichi Sankyo, Deruxtecan, EU, HER2, Metastatic, Positive, Recommended, trastuzumab

Novartis’ Ruxolitinib Fails to Meet its Primary Endpoint in P-lll RUXCOVID Study for COVID-19

Published: Dec 14, 2020 | Tags: COVID-19, Novartis, P-lll, reports, results, RUXCOVID Study, ruxolitinib

AstraZeneca’s Trixeo Aerosphere Receives EU’s Approval for the Maintenance Treatment of COPD

Published: Dec 14, 2020 | Tags: AstraZeneca’s, China, EU’s Approval, Japan, moderate to severe chronic obstructive pulmonary disease (COPD), receives, Trixeo Aerosphere, US

Alvotech and Fuji Pharma Extends Agreement for the Commercialization of Four Biosimilars in Japan

Published: Dec 10, 2020 | Tags: Agreement, Alvotech, Biosimilar, Commercialization, Extends, Four, Fuji Pharma, Japan, Medicines

Pfizer and BioNTech’s BNT162b2 Receives the US FDA’s EUA to Prevent COVID-19

Date: Dec 11, 2020 | Tags: BioNTech, BLA, BNT162b2, COVID-19, EUA, files, Pfizer, Prevent, receives, Us FDA

AstraZeneca to Acquire Alexion for $39B

Published: Dec 12, 2020 | Tags: $39B, Acquires, Alexion, AstraZeneca

Related News: PharmaShots Weekly Snapshots (Dec 7-11, 2020)

The post PharmaShots Weekly Snapshots (Dec 14-18, 2020) first appeared on PharmaShots.

H1 Secures $58M to Expand Global Healthcare Data Platform

H1 Closes $58 Million Series B Co-Led by IVP and Menlo Ventures

What You Should Know:

– H1, the largest database of information on every doctor
in the world raises $58M in Series B funding, just six months after raising its
Series A round during the pandemic.

– H1 is the largest database in the world connecting that
provides comprehensive in-depth profiles of more than 9 million healthcare
professionals and 16,000 institutions in 70-plus countries, all of which are
kept up-to-date weekly.


 H1, a global
platform for the healthcare ecosystem, announced today that it has closed a $58
million Series B round of funding co-led by IVP and Menlo Ventures, which led
the Series A round in April 2020. Transformation Capital, Lux Capital, Lead
Edge Capital, Novartis dRx and YC also participated. 

Over 9 Million Healthcare Professional Profiles

Co-founded by Ariel Katz and Ian Sax in 2017, H1 is a developer of a healthcare data analytics platform intended to help companies make smarter scientific decisions. H1 has created the largest healthcare platform to forge connections in the healthcare ecosystem. The H1 team has taken a unique approach to building the platform that combines AI, human-powered engineering, third-party data sources, and government partnerships, to create the largest platform of healthcare professionals, currently spanning over 9 million healthcare professions around the globe.

The company specializes in providing real-time data to support the end-to-end therapeutic development process from fundraising to product development to product launch, thereby providing the healthcare industry, organizations, and professionals with on-demand, live insights from across the data universe to accelerate the discovery and development of therapies to fight diseases.

Traction/Milestones

H1 has enjoyed tremendous growth in 2020, surpassing
projections and proving the need for its platform of doctors is stronger than
ever. Following its Series A announcement in April 2020 of $12.9 million, the
company has grown from approximately 100 employees globally to nearly 250 and
anticipates expanding its headcount significantly over the next year, including
further expansion into Europe and Asia.

With over 50+ customers to date and growing rapidly, H1 is
slowly becoming the standard that companies think about when they want to find
the right Key Opinion Leading Doctors to collaborate with for Clinical Trial
Activity, Medical Activity, and Educational Activity. 

The platform has been a unique and powerful resource for
global pharma companies, including those working on COVID-19 vaccines and
therapeutics. In fact, 13 of the top 20 pharmaceutical companies are currently
using the platform for research and insights.

“We have created a platform for the healthcare ecosystem to connect in the same way Linkedin connected professional workers in the early 2000’s. There hasn’t been a global platform like H1 before that has connected industry to the right doctors the way H1 does,” said H1 co-founder and CEO Ariel Katz. “This next round of funding, with our excellent investment group, including Menlo who has been a great partner for us, will help us continue to become the largest healthcare professional platform and ultimately create a healthier future.”

Hospitals sue drug companies over discount program

The lawsuit follows action by at least a half-dozen drug companies to rein in what they see as waste and abuse in the program, overseen by the Department of Health and Human Services. Meanwhile, the Hospital plaintiffs have a potentially powerful ally in the person picked to head the department under the incoming Biden administration.

Novartis to Acquire Cadent Therapeutics for ~$770M

Shots:

  • Novartis to acquire all outstanding shares of Cadent for a total value of ~$770M. Cadent to receive $210M up front and is eligible for ~$560M as milestones. The transaction is expected to be close in Q1’21
  • Novartis gains full rights to Cadent’s NMDAr program which consist of two clinical programs: CAD-9303 and MIJ-821, an NMDAr negative allosteric modulator that was licensed to Novartis in 2015
  • Additionally, Novartis gains Cadent’s pre-clinical programs and clinical stage (CAD-1883) movement disorder program

Click here ­to­ read full press release/ article | Ref: Novartis | Image: PRNewswire

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Mitochondria destruction for Cancer Treatment; Atsena raises USD 55 Million financings; Novartis and Cadent Therapeutics collaboration; Neuron23’s strategy to tackle CNS disorders

Mitochondria destruction can help in Cancer Treatment 

Human cells require structures known as mitochondria for the generation of energy for their biochemical activities. Researchers at the Karolinska Institutet in Sweden thought that destroying these could be a strategy for cancer treatment. 

Following that hypothesis, scientists designed oral inhibitors, which could target mitochondrial DNA (mtDNA). In mice, treatment with the drug led to strong anti-tumour responses, decreasing tumour growth without affecting healthy cells, as per reported in Nature by the team.

The data promote further development of the drugs as potential first-in-class mitochondria inhibitors for the cancer treatment, the researchers stated in the paper.

Cancer cells require mitochondria for energy and for producing several building blocks to maintain their wild proliferation.

There had been previous attempts in which mitochondria were targetted for treatment of cancer but often directed to severe side effects because they are also vital for maintaining normal cell functions. The Karolinska-led team focused on a unique feature of cancer cells. As part of uncontrolled cell division, cancer cells must regularly make new mitochondria. Instead of directly targeting existing mitochondria, the team went after mitochondrial DNA transcription that is vital to the formation of new mitochondria and the production of energy.

Atsena raises USD 55 Million financings for blindness gene therapy

University of Florida (UF) spinout Atsena Therapeutics has completed a USD 55 million financing that will benefit its gene therapy for a common cause of blindness in children into pivotal trials.

The gene therapy is already in a phase 1/2 trial for Leber congenital amaurosis (LCA), a disease, which progressively damages the retina, in patients with a mutation in the GUCY2D gene. Atsena took the candidate from Sanofi earlier this year that licensed it from UF.

The Durham, North Carolina-based biotech is aspiring to follow in the footsteps of Spark Therapeutics, whose Luxturna became the first directly administered gene therapy to be sanctioned in the U.S. in 2017.

Luxturna has been authorized for LCA caused by mutations in the RPE65 gene, and another inherited retinal disease called Retinitis Pigmentosa.

Atsena’s GUCY2D therapy, known as SAR439483, emerged from the lab of Atsena co-founder and Chief Scientific Officer Shannon Boye, PhD, and co-founder and Chief Technology Officer Sanford Boye, both are working at UF’s College of Medicine.

The therapy is being administered by subretinal injection to one eye of each patient in the phase 1/2 study with an aim that the untreated eye can serve as a placebo, with a year of follow-up after dosing. Preliminary results are expected in the first half of next year.

Novartis collaborates with neuro partner Cadent for USD 210 Million upfront 

Novartis collaborated with Cadent Therapeutics on treatment-resistant depression back when the neuro-focused biotech was working under the radar. Five years after, the Swiss pharma is backing itself to the rest of Cadent’s pipeline in a contract worth USD 210 million upfront, but that could make the latter up to USD 770 million in whole. 

Novartis will take over all of Cadent’s outstanding stock in exchange for the upfront fee and up to USD 560 million in milestone payments. The duo anticipates the pact to end in the first quarter of 2021.

Under the agreement, Novartis will acquire the milestones and royalties for the depression asset, MIJ821, which is in testing phase 2 study. It also picks up CAD-9303, a schizophrenia treatment, and CAD-1883 that is in development for movement disorders.

As Novartis pushed its depression asset through the clinic, the progress of CAD-9303, Cadent’s schizophrenia program, forced it to turn the partnership into an acquisition, as said by Gopi Shanker, interim co-head of neuroscience at Novartis Institutes for BioMedical Research (NIBR).

Neuron23 reveals with USD 113.5 Million to tackle CNS disorders 

Scientists at Neuron23, since October 2018, have worked to discover their place in the world of precision medicine. That place is utilizing artificial intelligence and data science to aim neurodegenerative and neuroinflammatory diseases in patients with specific genetic mutations.

It was founded through a partnership with Germany’s Origenis, Neuron23 launches USD 113.5 million in financing. The funds comprise USD 30 million in series A funding from Westlake Village BioPartners and Kleiner Perkins and a USD 80 million Series B led by Redmile Group, will drive two to three programs into the clinic in the next two years.

Neuron23’s lead program targets Leucine-rich repeat kinase 2 (LRRK2). It is a gene, which codes for a kinase enzyme of the same name. Mutations in this gene are strongly associated with 3% of patients with Parkinson’s disease. Neuron23 CEO Nancy Stagliano, PhD, said that finding a small-molecule inhibitor for LRRK2, which has an evident genetic linkage to disease, can render a foundation of biological knowledge to treat the other 97% of Parkinson’s patients.

The second program is pursuing brain-penetrant inhibitors for tyrosine kinase 2 (TYK2), a kinase, which leads to multiple sclerosis

The post Mitochondria destruction for Cancer Treatment; Atsena raises USD 55 Million financings; Novartis and Cadent Therapeutics collaboration; Neuron23’s strategy to tackle CNS disorders appeared first on DelveInsight Business Research.

Novartis buys neurology biotech Cadent for up to $770m

Novartis is to buy neuroscience drugs firm Cadent Therapeutics in a deal worth up to $770 million.

The big Swiss pharma already has a presence in neurology with its multiple sclerosis drug Gilenya (fingolimod) and the more recently approved Aimovig (erenumab).

With the acquisition of Cambridge, Massachusetts-based Cadent, Novartis gains rights to a portfolio of neurology drugs.

This includes CAD-9303, a NMDAr positive allosteric modulator that could be used to treat schizophrenia, and MIJ-821, a NMDAr negative allosteric modulator for depression that was licensed to Novartis in 2015.

MIJ-821 is already in phase 2 development for treatment-resistant depression in a trial overseen by Novartis and the acquisition includes a buyout of milestones payments and royalties for the drug.

Gopi Shanker, the interim co-head of neuroscience at the Novartis Institutes for BioMedical Research (NIBR), added: “There is good evidence, both from human genetics as well as clinical studies, that NMDA receptors, which regulate learning, memory and plasticity in the brain function sub-optimally in schizophrenia.

“By modulating the activity of these receptors, we think CAD-9303 could potentially treat negative and cognitive symptoms and help address one of the key gaps in schizophrenia care.”

Additionally, Novartis will gain full rights to CAD-1883, a clinical stage SK channel positive allosteric modulator in development for movement disorders.

Cadent, which launched in 2017 through the merger of Luc Therapeutics and Ataxion Therapeutics, will receive $210 million up front, and up to $560 million in milestone payments.

No other financial details were disclosed.

Cadent said that its pipeline of drugs could also be used to treat indications such as movement disorders.

The transaction has been approved by the board of directors and stockholders of Cadent Therapeutics. Cadent and Novartis expect the transaction will close during the first quarter of 2021.

Closing of the transaction is subject to customary closing conditions, including antitrust review under us antitrust laws.

Investors in Cadent include Atlas Venture, Cowen Healthcare Investments, Qiming Venture Partners, Access Industries, Clal Biotechnology Industries, Novartis Corporate and Slater Technology Fund.

 

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Novartis’s Zolgensma Receives Health Canada Approval as the One-Time Gene Therapy for Pediatric Patients with SMA

Shots

  • The Health Canada has approved Zolgensma (onasemnogene abeparvovec) for pediatric patients with 5q SMA with bi-allelic mutations in the SMN1 gene and 3 or fewer copies of SMN2 gene or infantile-onset SMA
  • The efficacy and safety data supporting the approval of Zolgensma are derived from completed and ongoing studies in patients with SMA and 2 copies of SMN2 gene and presymptomatic genetically diagnosed SMA and 2 or 3 copies of SMN2 gene
  • Zolgensma (IV) is a gene therapy designed to address the genetic root cause of SMA by replacing the missing or defective SMN1 gene

Click here ­to­ read full press release/ article | Ref: Newswire Canada | Image: Bloomberg

The post Novartis’s Zolgensma Receives Health Canada Approval as the One-Time Gene Therapy for Pediatric Patients with SMA first appeared on PharmaShots.

Novartis’s Entresto Receives the US FDA’s Advisory Committee Recommendation to Treat Patients with HFpEF

Shots:

  • The US FDA’s CRDAC voted 12 to 1 supporting the use of Entresto (sacubitril/valsartan) in the treatment of patients with HFpEF
  • The decision was based on efficacy & safety analyses, including findings from a pre-specified subgroup analysis of PARAGON-HF (P-III study in HFpEF) and additional evidence from PARAMOUNT (P-II trial in HFpEF), as well as PARADIGM-HF (P-III trial in HFrEF)
  • Entresto (sacubitril/valsartan) is a prescription medicine used to reduce the risk of CV death & heart failure hospitalization in people with long-lasting heart failure

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: BioSpace

The post Novartis’s Entresto Receives the US FDA’s Advisory Committee Recommendation to Treat Patients with HFpEF first appeared on PharmaShots.

Entresto set for big sales hike after FDA panel endorsement

Novartis’ Entresto is on course to become the first drug to be approved in the US for a form of heart failure that is notoriously hard to treat effectively, despite missing the mark in a phase 3 trial.

An FDA advisory committee 12 to 1 in favour of approving Entresto (sacubitril/valsartan) for heart failure with preserved ejection fraction (HFpEF), which accounts for around half of all heart failure cases but proves highly resistant to drug treatment. In HFpEF, the heart muscles pump normally but the organ is too stiff to fill properly.

Entresto is already approved to treat heart failure with reduced ejection fraction (HFrEF), caused by the heart muscles not pumping effectively, and has revitalised the treatment of patients with this form since its launch in 2015.

After a slow start, it has grown to become a $1.7 billion product last year, and that represented a surge from around $1 billion in 2018 revenues.

Analysts have predicted that approval in HFpEF – which affects around 3 million people in the US alone – could more than double Entresto’s sales, perhaps driving them as a high as $5 billion a year. There’s also plenty of upside in HFrEF as three out of four eligible patients are still not being treated with the drug, according to Novartis.

The prospect of adding HFpEF to Entresto’s label looked shaky last year however, when the drug missed its primary objective in the phase 3 PARAGON-HF trial.

The 4,822-patient study missed statistical significance for a composite primary endpoint of reducing cardiovascular death and total heart failure hospitalisations by 13% compared with valsartan alone, but only by a whisker, and Novartis has been upbeat since about the chances of approval.

The published data from the study suggested that the drug performed better in women, people with structural abnormalities in the left ventricles of their hearts, and those with very low ejection fractions – the amount of blood pushed out of the heart each beat.

The positive vote by FDA advisors came after the FDA reviewer acknowledged the narrow miss for statistical significance and pointed to the pressing need for a drug treatment for HFpEF.

The agency’s own expert said that “various pre-specified and post-hoc analyses suggest that sacubitril/valsartan compared to valsartan reduces HF events” in HFpEF, and of course Entresto’s long track record of safety stands in its favour.

While the FDA doesn’t have to follow its advisory committee’s advice it generally does, and Novartis is now eyeing approval of Entresto in HFpEF in the first quarter of 2021.

The main question now is exactly how the FDA will word the label if it approves the drug, with panellists debating the use of ejection fractions percentages to guide treatment with little agreement.

PARAGON-HF in included patients with left ventricular ejection fraction (LVEF) of 45% or more, but earlier studies have suggested the drug can have a benefit in people with scores below 40%.

The post Entresto set for big sales hike after FDA panel endorsement appeared first on .

Novartis’ Ruxolitinib Fails to Meet its Primary Endpoint in P-lll RUXCOVID Study for COVID-19

Shots:

  • The P-lll RUXCOVID study involves assessing Ruxolitinib (5mg, bid) + SoC therapy vs PBO + SoC therapy in 432 patients aged ≥12 yrs. in a ratio (2:1) hospitalized for COVID-19 and not intubated or receiving ICU care prior to randomization
  • The study did not meet its 1EPS of reducing the number of hospitalized COVID-19 patients who experienced severe complications @29days (death, mechanical ventilation or ICU care i.e. (12% vs 11.8%). The trial did not show benefits among 2EPs and exploratory endpoints including mortality rate @Day29 and time to recovery
  • Ruxolitinib is an oral JAK 1 and JAK 2 tyrosine kinases inhibitor and is approved under the name Jakavi in EU and other countries for PV & MF

Click here ­to­ read full press release/ article | Ref: Novartis | Image: Financial Times

The post Novartis’ Ruxolitinib Fails to Meet its Primary Endpoint in P-lll RUXCOVID Study for COVID-19 first appeared on PharmaShots.

Novartis/Incyte draw blank with Jakafi in COVID-19

Novartis/Incyte’s Jakafi (ruxolitinib) looks unlikely to be added to the list of therapies that can be used against COVID-19, after it failed to cut complications or death in a phase 3 trial.

Data from the phase 3 RUXCOVID study showed that there was no significant reduction in the proportion of COVID-19 patients on ruxolitinib plus standard therapy experiencing severe complications, compared to standard care alone.

Severe complications included death, respiratory failure requiring mechanical ventilation or admission to intensive care.

RUXCOVID is a 29-day placebo-controlled trial testing ruxolitinib in 432 patients aged 12 years or over in patients hospitalised for COVID-19 and not intubated or receiving intensive care before randomisation.

Results were measured against a composite primary endpoint of patients who died, developed respiratory failure requiring mechanical ventilation, or required admission to ICU by day 29.

But the proportion of people meeting this endpoint was almost identical in the two groups – 12% for those treated with ruxolitinib and 11.8% for those treated with placebo plus standard care.

Patients were randomised 2:1 to receive ruxolitinib twice daily or oral-matching placebo for 14 days, with standard therapy decided according to the investigator’s clinical judgement.

Ruxolitinib is already FDA approved under the brand name Jakafi to treat the bone marrow diseases myelofibrosis, polycythemia vera and graft-versus-host disease.

Trials of the drug in other indications are not affected by the outcome, Novartis said.

The drug is an oral inhibitor of JAK 1 and JAK 2 tyrosine kinases and the rationale behind the trial was to investigate whether the down regulation of the immune system conferred by the medicine would reduce the inflammation caused by COVID-19.

Originally developed by Incyte, Novartis licensed in the drug for development and marketing outside the US.

The RUXCOVID trial is sponsored by Novartis outside of the US and by Incyte inside the US.

Many drugs are being trialled against COVID-19, with the cheap steroid dexamethasone producing some of the most promising trial results.

Although Gilead’s Veklury (remdesivir), an antiviral originally intended to treat Ebola, is approved in the US to treat COVID-19 the World Health Organization has recommended against using it because of differing interpretations of trial results.

 

The post Novartis/Incyte draw blank with Jakafi in COVID-19 appeared first on .

PharmaShots Weekly Snapshots (Dec 7-11, 2020)

Roche Launches Elecsys SARS-CoV-2 Antigen Test to Support High-Volume COVID-19 Testing

Published: Dec 11, 2020 | Tags: Antigen, COVID-19, High, Laboratory, Launch, patients, Roche, SARS-CoV-2, Support, Suspected, Test, Testing, Volume

Chugai In-Licenses Roche’s Antibody Cocktail for COVID-19 in Japan

Published: Dec 10, 2020 | Tags: Casirivimab, Chugai, Commercialization, COVID-19, Development, Imdevimab, In-License Agreement, Japan, Roche, Sign

Roche Presents Results of Tecentriq (atezolizumab) in P-III IMvigor010 Study for MIUC at ESMO 2020

Published: Dec 10, 2020 | Tags: (atezolizumab), ESMO Virtual Congress 2020, IMvigor010 Study, Muscle-Invasive Urothelial Cancer (MIUC), P-III, reports, results, Roche, Tecentriq

Biogen Reports NDA Submission of Aducanumab (BIIB037) to the MHLW for Alzheimer’s Disease

Published: Dec 9, 2020 | Tags: (BIIB037) US FDA, aducanumab, Alzheimer Disease, Biogen, J-NDA Submission, reports

Gilead to Acquire MYR for ~$1.4B

Published: Dec 10, 2020 | Tags: ~$1.4B, Acquire, Gilead Sciences, MYR GmbH

Boehringer Ingelheim to Acquires NBE-Therapeutics ~ $1.5B

Published: Dec 10, 2020 | Tags: Acquires, Boehringer Ingelheim, NBE-Therapeutics

Pfizer and BioNTech ‘s BNT162b2 Receive Health Canada Authorization to Combat COVID-19

Published: Dec 9, 2020 | Tags: (BNT162b2), BioNTech, COVID-19, Health Canada Authorization, Interim Order, patients, Pfizer, receives

Google Launches Health Research App Focusing on Respiratory Illnesses

Published: Dec 9, 2020 | Tags: App, COVID-19, Flu, Google, Launches, Virtual Medical Research

Novartis Reports Results of Kisqali in P-III MONALEESA-7 Trial to Treat HR+/HER2- Metastatic Breast Cancer

Published: Dec 9, 2020 | Tags: HR+/HER2- Metastatic Breast Cancer, Kisqali, MONALEESA-7 Trial, Novartis, P-III, reports, results

Roche Collaborate with Moderna to include SARS-CoV-2 Ab Test in COVID-19 Vaccine Trials

Published: Dec 9, 2020 | Tags: Collaborates, COVID-19, Moderna, Roche, SARS-CoV-2 Ab Test, Vaccine Trials

Lilly Reports Results of Tirzepatide in P-lll SURPASS-1 Monotherapy Trial for Type-2 Diabetes

Published: Dec 9, 2020 | Tags: Lilly, Monotherapy Trial, P-lll, reports, results, SURPASS-1, Tirzepatide, Type-2 diabetes

Boehringer Ingelheim to Acquires Labor Dr. Merk & Kollegen for Boosting its Next Generation Cancer Immunology Program

Published: Dec 9, 2020 | Tags: Acquires, Boehringer, Cancer Immunology Program, Kollegen, Labor Dr. Merk, Next Generation, Strength

Elsevier Acquires Shadow Health

Published: Dec 9, 2020 | Tags: Acquires, Elsevier, Extensive Portfolio, Shadow Health

Roche Highlights its Bispecific Antibody Portfolio Across a Range of Blood Cancers at ASH 2020

Published: Dec 8, 2020 | Tags: 62, Across, ALL, Annual, antibody, ASH, Bispecific, Blood, cancers, Data, From, Meeting, Portfolio, Presents, Range, Roche, Virtual

Amgen’s Sotorasib Receives the US FDA’s Breakthrough Therapy Designation for Advanced or Metastatic NSCLC with KRAS G12C Mutation

Published: Dec 8, 2020 | Tags: Advanced or Metastatic Non-Small Cell Lung Cancer, Amgen, Breakthrough Therapy Designation, KRAS G12C, Mutation, receives, Sotorasib, US FDA’s

Medtronic Launches Carpediem as the First Pediatric and Neonatal Acute Dialysis Machine in the US

Published: Dec 8, 2020 | Tags: Acute, Carpediem, Dialysis, First, Launch, Machine, Medtronic, neonatal, Only, Pediatric, System, US

AstraZeneca Reports Results of AZD1222 in Interim Analysis of P-lll Program for COVID-19

Published: Dec 8, 2020 | Tags: AstraZenca, AZD1222, Clinical Trials, COVID-19, Four, Interim Analysis, P-lll, reports, results

Novartis’ Asciminib (ABL001) Demonstrate Superiority Over Pfizer’s Bosulif in Chronic Myeloid Leukemia Trial

Published: Dec 8, 2020 | Tags: (ABL001), ASCEMBL Study, Asciminib, Chronic, Chronic Myeloid Leukemia, Novartis, P-lll, Philadelphia Chromosome, reports, results

RetinAI Collaborates with Novartis to Provide AI Solutions in Ophthalmology

Published: Dec 8, 2020 | Tags: Artificial Intelligence, Multi-Year Collaboration, Novartis, Ophthalmology, Provide, RetinAI, Signs, Solutions

Astellas Collaborates with KaliVir to Develop and Commercialize VET2-L2

Published: Dec 7, 2020 | Tags: Agreement, Astellas, Commercialization, Development, KaliVir Immunotherapeutics, Novel, Oncolytic, Signs, VET2-L2, Virus

Qiagen Launches QuantiFERON SARS-CoV-2 RUO Solution for COVID-19

Published: Dec 7, 2020 | Tags: COVID-19, Launches, Qiagen, QuantiFERON, SARS-CoV-2 RUO, Solution

Bayer Signs an Exclusive Worldwide License Agreement with Atara for Mesothelin-Targeted CAR T-cell Therapies to Treat Solid Tumors

Published: Dec 6, 2020 | Tags: Agreement, Atara, Bayer, Exclusive, License, Mesothelin-Targeted CAR T-cell Therapies, Signs, Solid Tumors, Worldwide

Nektar Therapeutics Presents Preclinical Data of NKTR-255 in P-Ib/II Study at ASH 2020

Published: Dec 7, 2020 | Tags: 2020, 62nd, Annual, ASH, Meeting, Nektar Therapeutics, NKTR-255, P-Ib/II, preclinical, Presents, results, study

AbbVie Reports Results of Imbruvica (ibrutinib) in Two P-III Studies as 1L Treatment for Chronic Lymphocytic Leukemia

Published: Dec 6, 2020 | Tags: (ibrutinib), 1L treatment, AbbVie, CLL, ILLUMINATE Study, Imbruvica, Integrated Analysis, Long-Term, P-lll, reports, RESONATE-2

Roche Reports of Polivy + Bendamustine and MabThera / Rituxan in P-lb/ll GO29365 Study for R/R Diffuse Large B-Cell Lymphoma

Published: Dec 7, 2020 | Tags: (polatuzumab vedotin), (R/R) Diffuse Large B-Cell Lymphoma, Bendamustine, GO29365 Study, MabThera / Rituxan (rituximab), P-lb/ll, Polivy, reports, Result, Roche

Roche Presents Results of Hemlibra Reinforcing the Long-Term Benefits for Hemophilia A at ASH 2020

Published: Dec 7, 2020 | Tags: 62nd, Annual, ASH, Haemophilia A, HAVEN, Hemlibra, I-IV, Meeting, P-III, People, Presents, results, Roche, Studies, Virtual

AstraZeneca Reports Long-Term Efficacy and Tolerability of Calquence (acalabrutinib) in P-ll ACE-LY-004 Study for MCL

Published: Dec 7, 2020 | Tags: (acalabrutinib) in P-ll ACE-LY-004 Study for Relapsed or Refractory Mantle Cell Lymphoma, AstraZenca, Calquence, Long-Term Efficacy, reports, Tolerability

Roche Reports Long-Term Benefits of Venclexta/Venclyxto Based Combination for R/R Chronic Lymphocytic Leukemia

Published: Dec 5, 2020 | Tags: Based, CLL14, combination, MURANO, P-III, People, R/R CLL, reports, results, Roche, Studies, Venclexta, Venclyxto

Kite Reports Results of Yescarta in P-II ZUMA-5 Study for Adult Patients with R/R Indolent Non-Hodgkin Lymphoma

Published: Dec 5, 2020 | Tags: Adult, iNHL, Kite, P-II, patients, Refractory, Relapsed, reports, results, study, Yescarta, ZUMA-5

Janssen Reports Long-Term Benefits of Imbruvica (ibrutinib) as 1L Treatment for High-Risk Chronic Lymphocytic Leukemia

Published: Dec 6, 2020 | Tags: (ibrutinib), 1L treatment, High-Risk Chronic Lymphocytic Leukaemia, ILLUMINATE Study, Imbruvica, Janssen, P-lll, reports, RESONATE-2, results

Related Post: PharmaShots Weekly Snapshot (Nov 30 – Dec 04, 2020)

The post PharmaShots Weekly Snapshots (Dec 7-11, 2020) first appeared on PharmaShots.

Novartis Reports Results of Kisqali in P-III MONALEESA-7 Trial to Treat HR+/HER2- Metastatic Breast Cancer

Shots:

  • The P-III MONALEESA-7 trial involves assessing Kisqali + endocrine therapy (goserelin + either an aromatase inhibitor or tamoxifen) as initial treatment vs endocrine therapy alone in patients with HR+/HER2- m-BC
  • Result: @53.5 mos. follow-up, m-OS (58.7 vs 48.0 mos.); similar m-OS (58.7 vs 47.7 mos.) observed in IIT population; @ 42 mos. follow-up, estimated survival rate (70.2% vs 46%)
  • The US FDA and EC has approved Kisqali in Mar’2017 and Aug’2017 as initial endocrine-based therapy for postmenopausal women with HR+/HER2- LA/m-BC in combination with an aromatase inhibitor based on findings from the pivotal MONALEESA-2 trial

Click here to­ read the full press release/ article | Ref: PRNewswire | Image: BioProcess International

The post Novartis Reports Results of Kisqali in P-III MONALEESA-7 Trial to Treat HR+/HER2- Metastatic Breast Cancer first appeared on PharmaShots.

Novartis’ Asciminib (ABL001) Demonstrate Superiority Over Pfizer’s Bosulif in Chronic Myeloid Leukemia Trial

Shots:

  • The P-lll ASCEMBL study involves assessing Asciminib (40mg, bid) vs Bosulif (bosutinib, 500mg, qd) in 223 patients with Ph+ CML-CP prior treated with two or more TKIs and the data were presented at 62nd (ASH) Annual Meeting & Exposition
  • Results: @ 24 wks. MMR rate (25.5% vs 13.2%) tCCyR rate (40.8% vs 24.2%); DMR rate were higher with patients achieving MR4 and MR5(10.8% and 8.9% vs 5.3% and 1.3%); Grade ≥3 AEs (50.6% and 60.5%) respectively, presented at ASH
  • The US FDA has granted FT designation for Asciminib while the regulatory submission to the US and EU health authorities is planned for H1’21

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: PMLiVE

The post Novartis’ Asciminib (ABL001) Demonstrate Superiority Over Pfizer’s Bosulif in Chronic Myeloid Leukemia Trial first appeared on PharmaShots.

Pear Therapeutics Raises $80M to Advance Prescription Digital Therapeutics

Pear Therapeutics Raises $80M to Advance Prescription Digital Therapeutics

What You Should Know:

– Pear Therapeutics today announced that it has
successfully closed an $80 million Series D financing led by SoftBank Vision
Fund 2.

–  Pear is the
leader in prescription digital therapeutics and the first company to receive
FDA authorization for a prescription digital therapeutic (PDT) to treat
disease.

– Pear currently has three FDA authorized therapies, reSET, reSET-O and Somryst, for substance use disorder, opioid use disorder, and chronic insomnia, respectively.


Pear Therapeutics,
Inc.
, (“Pear” or the “Company”) today announced that it has successfully
closed an $80 million Series D financing led by SoftBank Vision Fund 21 with
participation from existing investors including Temasek, 5AM Ventures,
Arboretum Ventures, JAZZ Venture Partners, Novartis, CrimsoNox, and EDBI, and
new investors, Forth Management, Pilot House, Sarissa Capital, Shanda Group,
and QUAD Investment Management.

What are PDTs?

PDTs are a new therapeutic class that uses software to treat
disease. Just like traditional medicines, prescription digital therapeutics are
prescribed by a physician and backed by clinical data that has been validated
by the FDA. As a new method of care, they offer patients a wide variety of
benefits, including: increased access to therapies, improved engagement and
adherence compared to face-to-face therapies.

Pear’s FDA Authorized Products

Pear’s products reSET®
and reSET-O® for the treatment
of substance use disorder and opioid use disorder, respectively, are the first
two PDTs to receive market authorization to treat disease from FDA. Pear
recently launched Somryst,
for the treatment of chronic insomnia, its third FDA-authorized PDT and the
third PDT to receive market authorization from FDA. Pear also recently launched
its end-to-end virtual care experience combining virtual doctor visit(s) via
telemedicine provider with PearConnect, the industry’s first patient service
center for PDTs.

The Company’s three FDA-authorized products address large
market opportunities with more than 20 million patients suffering from
substance and opioid use disorders and more than 30 million from chronic
insomnia, in the U.S. alone. These diseases are on the rise as the pandemic has
exacerbated the country’s mental health crises.

Expansion Plans

Pear plans to use the latest round of funding to accelerate
reimbursement coverage for its three commercial products, creating the first
market access pathway in the PDT industry. The Company collaborates with
innovators to build a broad and deep pipeline that has the potential to
redefine standard of care in a range of therapeutic areas, including specialty
psychiatry, specialty neurology, and a host of other non-CNS diseases. Pear has
built the first scalable platform infrastructure to discover, develop, and
deliver PDTs to patients.

“Pear is pleased to welcome our new investors and our new board members. SoftBank Investment Advisers represents an ideal partner to support Pear as we build the digital therapeutics industry,” said Corey McCann, M.D., Ph.D., President and CEO of Pear Therapeutics. “This oversubscribed round of funding will allow us to continue to invest in the launches of our three commercial products to accelerate revenue growth, which we intend to reinvest in our robust pipeline and platform.”

RetinAI Collaborates with Novartis to Provide AI Solutions in Ophthalmology

Shots:

  • RetinAI signs a multi-year collaboration with Novartis under which RetinAI’s IT solutions and AI tools will be employed to support multiple projects in ophthalmology and digital health
  • The first project under the agreement will support a multi-center international clinical study involving patients with nAMD. The study is designed to investigate the influence of OCT image solutions using AI on the assessment of disease activity
  • The study will be conducted across multiple centers in numerous EU countries and Canada, involving 500+ patients. RetinaAI will provide its data management platform to efficiently process data at scale across imaging platforms and devices

Click here ­to­ read full press release/ article | Ref: RetinAI | Image: Switzerland Global Enterprise

The post RetinAI Collaborates with Novartis to Provide AI Solutions in Ophthalmology first appeared on PharmaShots.

Novartis signs ophthalmology AI deal with RetinAI

Novartis has signed a multi-year agreement with RetinAI, which will see the companies work together to use artificial intelligence (AI) tools to support ophthalmology and digital health projects.

Both companies have already worked on pilot projects in this area.

The first project under a new master agreement will involve a multi-centre international clinical study involving patients with neovascular age-related macular degeneration (nAMD).

The study is designed to investigate the influence of optical coherence tomography image solutions, while using AI to assess disease activity.

The study will be conducted in several clinical centres in several European countries and Canada, involving more than 500 patients.

RetinAI will provide its CE-marked web-based platform, RetinAI Discovery, a data management platform that processes data at scale across imaging platforms and devices.

The technology is already used by professionals to navigate imaging data, compute imaging biomarkers and track changes over time for common eye diseases.

It also allows diagnostic analyses and clinical workflows as well as patient monitoring and adherence to treatment.

Dirk Sauer, global development head of the ophthalmology franchise at Novartis, said he saw RetinAI as a strategic partner for advancing eye care through digital innovation.

He said: “With previous projects, RetinAI’s services have enabled us to enhance and more efficiently structure retina scans and data collected from our clinical studies.

“Together with RetinAI, we are working on end-to-end solutions to generate swift and comprehensive disease insights to better treat patients and improve patient outcomes.”

Since Vas Narasimhan was appointed CEO more than two years ago, the company has made adoption of digital technology one of its priorities.

The idea is to use digital technology to enhance the company’s portfolio of pharmaceutical products.

One of Narasimhan’s first decisions when he took charge was to appoint chief digital officer Bertrand Bodson, who joined the company’s executive committee shortly after he joined.

 

 

The post Novartis signs ophthalmology AI deal with RetinAI appeared first on .

PharmaShots Weekly Snapshot (Nov 30 – Dec 04, 2020)

Richter Acquires Janssen’s Evra Transdermal Contraceptive Patch Assets for $263.5M

Published: Dec 3, 2020 | Tags: Asset Purchase Agreement, Evra, Gedeon Richter, Janssen Pharmaceutical, Signs, Transdermal Contraceptive Patch Assets, Treat

Jazz Pharma and PharmaMar’s Zepzelca Fail to Meet its Primary Endpoint in P-III ATLANTIS Study for SCLC

Published: Dec 3, 2020 | Tags: ATLANTIS, Doxorubicin, Jazz Pharma, P-III, patients, PharmaMar, results, SCLC, study, Zepzelca

reMYND Commences P-l Study of RES19-T for Alzheimer’s Disease

Published: Dec 3, 2020 | Tags: Alzheimer, Commencement, First-in-Human, P-l, reMYND, RES19-T, Treatment, Trial

Abbott’s FreeStyle Libre 2 Receives Health Canada’s Approval for Adults and Children with Diabetes

Published: Dec 2, 2020 | Tags: Abbott, Adults, approval, canada, Children, Diabetes, FreeStyle Libre 2, health, receives

Exactech Acquires Muvr and its Digital Health Tech for Orthopedic Practices

Published: Dec 2, 2020 | Tags: Acquires, Exactech, Muvr Labs, Orthopedic

Janssen Reports BLA Submission of Amivantamab to the US FDA for Metastatic NSCLC with EGFR Exon 20 Insertion Mutations

Published: Dec 3, 2020 | Tags: Janssen, Reports, BLA Submission, Amivantamab, US FDA, Metastatic NSCLC, EGFR Exon 20 Insertion Mutations

Merck KGaA Collaborates with Artios Pharma for DNA Damage Cancer Therapies

Published: Dec 3, 2020 | Tags: Agreement, Artios Pharma, Damage, DNA, Merck KGaA, Novel, Oncology, Response, Signs, Targets

Janssen Acquires Rights to Hemera’s HMR59 for Late-Stage Age-Related Macular Degeneration

Published: Dec 2, 2020 | Tags: Acquires, Age Related Macular Degeneration, Biosciences, Gene, Hemera, Janssen, Late, Novel, Pioneering, Rights, Solutions, Stage, therapy, Treatment

AstraZeneca to Unveil its Robust Pipeline of Breast Cancer at SABCS

Published: Dec 3, 2020 | Tags: AstraZenca, DESTINY-Breast01, Enhertu, HER2 -Positive Metastatic Breast Cancer, HR, P-l, P-ll, reports, results, SERD AZD9833, SERENA-1 Study

AbbVie Collaborates with Frontier Medicines to Develop Novel Therapies and E3 Degraders Against Difficult-to-Drug Targets

Published: Dec 2, 2020 | Tags: AbbVie, Agreement, Develop, Discover, E3 Degraders, Frontier Medicines, Novel Therapies, Sign

Roche’s Elecsys Anti-SARS-CoV-2 S Receives the US FDA’s EUA to Detect Ab Against SARS-CoV-2 Spike Protein

Published: Dec 2, 2020 | Tags: (Anti-SARS-CoV-2 S), COVID-19, Elecsys, EUA, Receive, Roche’s, US FDA’s

Pfizer & BioNTech Receives MHRA’s EUA for BNT162b2 Against COVID-19

Published: Dec 2, 2020 | Tags: Against, BioNTech, BNT162b2, COVID-19 COVID-19, EUA, MHRA, Pfizer, receives, Regulatory, UK

Roche’s Gavreto (pralsetinib) Receives the US FDA’s Approval for Advanced or Metastatic RET-Mutant and RET Fusion-Positive Thyroid Cancers

Published: Dec 2, 2020 | Tags: (pralsetinib), Advanced or Metastatic RET-Mutant, Gavreto, receives, RET Fusion-Positive Thyroid Cancers, Roche’s, US FDA’s Approval

AstraZeneca to Divest European Rights of Crestor (rosuvastatin) to Grünenthal for ~$350M

Published: Dec 1, 2020 | Tags: $350M, Acquire, Agreement, AstraZeneca, CRESTOR, European, Grünenthal, Rights, rosuvastatin, Signs

Regeneron Collaborates with Penn to Explore Intranasal Delivery of COVID-19 Ab Cocktail via Gene Therapy Platform

Published: Dec 1, 2020 | Tags: Casirivimab, Collaborates, COVID-19 Antibody Cocktail, Delivery, Gene Therapy Platform, Imdevimab, Investigate, Penn, Regeneron

Boston Scientific to Divest BTG’s Specialty Pharma Business for ~$800M

Published: Dec 1, 2020 | Tags: Agreement, Boston, BTG, business, International, Pharmaceuticals, Scientific, Sell, Signs, Specialty, Stark

BioNTech and Pfizer Report CMA Submission of BNT162b2 to EMA for COVID-19

Published: Dec 1, 2020 | Tags: application, BioNTech, BNT162b2, CMA, Covid-19 Vaccine, EMA, Pfizer, Submitted

Genentech and Novartis’s Xolair (omalizumab) Receives the FDA’s Approval for Adults with Nasal Polyps

Published: Dec 1, 2020 | Tags: Adults, approval, Genentech Xolair, Nasal Polyps, Novartis, omalizumab, receives, US FDA

Eisai Sign a Research Agreement with Wren Therapeutics to Discover Potential Treatment for Synucleinopathies

Published: Nov 30, 2020 | Tags: Discover, Eisai, Novel Small Molecule, Research Agreement, Sign, Synucleinopathies, Wren Therapeutics

 AstraZeneca Initiates P-IIb Study of ION449 (AZD8233) to Lower LDL-cholesterol

Published: Nov 30, 2020 | Tags: Antisense, AstraZeneca, Initiates, ION449, Ionis, LDL-C, Lower, Medicine, P-IIb, PCSK9, reports, study, Targeting

Kaia Health Allied with Chiesi Group to Commercialize COPD App in Europe

Published: Nov 30, 2020 | Tags: Agreement, Chiesi Group, Europe, Kaia Health, Sign

Member of COVID R&D Alliance Report the First Patient Enrollment in COMMUNITY Study

Published: Dec 1, 2020 | Tags: Amgen, COMMUNITY, COVID-19, enrolled, First, Patient, patients, reports, Takeda, Trial, UCB

Sanofi’s Dupixent (dupilumab) Receives EC’s Approval for Children with Severe Atopic Dermatitis

Published: Nov 30, 2020 | Tags: (dupilumab), Atopic Dermatitis, Dupixent, European Commission Approval, receives, Sanofi’s

Moderna to Seek the FDA and EMA’s EUA for mRNA-1273 and Shows 100% Efficacy in P-III COVE-Study

Published: Nov 30, 2020 | Tags: 100%, 94.1%, COVID-19, Effective, EUA, Filing, Moderna, mRNA, Severe, Shows, Today, Us FDA, vaccine

AstraZeneca’s Forxiga (dapagliflozin) Receives MHLW’s Approval for Chronic Heart Failure

Published: Nov 30, 2020 | Tags: approval, AstraZeneca, Chronic Heart Failure, dapagliflozin, Forxiga, Japan, MHLW, receives, Treatment

AbbVie and Eisai’s Humira (adalimumab) Receives MHLW’s Approval for Pyoderma Gangrenosum

Published: Nov 27, 2020 | Tags: (adalimumab), AbbVie, Additional, Eisai, Humira, Indication, MHLW Approval, Pyoderma Gangrenosum, receives

Shionogi and Nagasaki University Collaborate with the Kitasato Institute for Antimalarial Drugs

Published: Nov 25, 2020 | Tags: Agreement, Antimalarial, drugs, Kitasato Institute, Nagasaki, Shionogi, Signs, University

Shionogi Receives MHLW’s Approval for Xofluza’s sNDA to Treat Post-Exposure Prophylaxis of Influenza Virus Infection

Published: Nov 27, 2020 | Tags: (baloxavir marboxil), approval, Infection, Influenza Virus, MHLW, Post-Exposure Prophylaxis, receives, Shionogi, sNDA, Treat, Xofluza

Moderna Amends its Agreement with UK Government for an Additional 2M Doses of COVID-19 Vaccine

Published: Nov 29, 2020 | Tags: 2M, Additional, Against, Agreement, Amends, COVID-19, doses, Government, Moderna, mRNA, mRNA-1273, UK, vaccine

Dr. Reddy’s to Divest Select Anti-Allergy brands to Dr. Reddy’s in Russia and Other CIS Countries

Published: Nov 28, 2020 | Tags:  Acquire, Dr. Reddy, Glenmark, Kazakhstan, Russia, Ukraine, Uzbekistan

Related Post: PharmaShots Weekly Snapshot (Nov 23 – 27, 2020)

The post PharmaShots Weekly Snapshot (Nov 30 – Dec 04, 2020) first appeared on PharmaShots.

Genentech and Novartis’s Xolair (omalizumab) Receives the FDA’s Approval for Adults with Nasal Polyps

Shots:

  • The approval is based on P-III POLYP 1 & 2 trials assessing Xolair vs PBO in 138 & 127 adult patients with nasal polyps who had an inadequate response to nasal corticosteroids respectively
  • Results: @24wks. improvement in NPS (-1.1 vs 0.1 & -0.9 vs -0.3); improvement in NCS (-0.9 vs -0.4 & -0.7 vs -0.2); no new or unexpected safety signals were identified respectively
  • Xolair is the first biologic for the treatment of nasal polyps that targets and blocks IgE. In the US, Novartis & Genentech work together to develop and co-promote Xolair

Source1, Source2 ­to­ read full press release/ article | Ref: Genentech & Novartis | Image: Dr. Thomas Chacko

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Novartis set to overcome $14 billion patent cliff say analysts

Novartis’ pipeline is strong enough to overcome a $14 billion patent cliff as blockbuster drugs face generic competition in the coming years, analysts have said.

Following a briefing with management, a team of analysts led by Peter Welford said that the big Swiss pharma will be propped up by its psoriasis and infectious diseases blockbuster Cosentyx for some time.

Although the drug has lost market share to rivals in psoriasis, there is still more to come from Cosentyx thanks to potential new uses in ankylosing spondylitis, psoriatic arthritis and six new indications.

This will be helped by a new 300mg pre-filled syringe and auto-injector have halved administrations, although there is an intravenous option for administration by doctors treating US Medicare patients.

This is supported by the company’s portfolio of other approved medicines and revenues from its Sandoz biosimilars and generics division.

In the short term, the analysts predict “flattish” Q4 sales, although they noted that the company may benefit from cost savings introduced during the COVID-19 pandemic.

Jefferies expects that the company expects sales of $14 billion could be at risk by 2027 from patent expiries of Tasigna, Promacta, Jakavi, Gilenya and Entresto.

But the analysts said that sales growth will continue despite the headwind thanks to “underappreciated” drugs in the late-stage pipeline.

Four key drugs outlined by Jefferies have combined peak potential of $14 billion –  the high lipoprotein cardiovascular disease drug pelacarsen, iscalimab for organ transplant and Sjogren’s syndrome, the rare disease drug iptacopan and the leukaemia drug sabatolimab.

Other important phase 3 drugs that are due to read out are Lu-PSMA in prostate cancer and canakinumab in lung cancer.

The company’s Sandoz division will also chip in with growing sales from its portfolio of biosimilars – cut-price near-copies of established biologic drugs that have been shown to be as safe and effective in rigorous tests and clinical trials.

Uptake of biosimilars in the US has been better than hoped, perhaps aided by hospitals focusing on cost because COVID-19 has curtailed income from surgery.

The post Novartis set to overcome $14 billion patent cliff say analysts appeared first on .

Novartis taps smartpatient for app to support wet AMD patients

German digital health company smartpatient is adding a new section of its MyTherapy app providing information on wet age-related macular degeneration (AMD), a leading cause of blindness.

The Munich-based company is launching the educational See What’s Next app in collaboration with Novartis, which sells the wet AMD medicines Beovu (brolucizumab) and Lucentis (ranibizumab), and has also been a big proponent of digital health technologies.

Wet AMD affects more than 20 million people worldwide, and is the top cause of blindness in people aged over 65. It develops when abnormal blood vessels grow into the macula of the eye. These vessels leak blood or fluid which leads to scarring of the macula and rapid loss of central vision.

While injecting drugs like Beovu, Lucentis and Bayer/Regeneron’s rival Eylea (aflibercept) into the eye can slow down the progressive loss of vision associated with the disease – particularly if wet AMD is diagnosed early – careful adherence to therapy is critical for treatment to work effectively.

The new, free of charge section makes tailored information about wet AMD available to the approximately 20 million people worldwide with wet AMD along with tools to help them stay on track with treatment and in communication with their doctors.

“Non-adherence is a challenge in most health conditions, but in few are consequences as direct and severe as in wet AMD,” says Sebastian Gaede, smartpatient’s chief executive.

See What’s Next is available to patients through their ophthalmologists, according to smartpatient, which has co-created the wet AMD app with Novartis, and will roll out initially in Italy and Spain with additional markets planned in the coming months.

MyTherapy has already been downloaded by millions of people around with world, and has more than 80,000 ratings on Apple’s App Store and Google’s Play Store – which smartpatient claims makes it the world’s fastest-growing disease management app.

Novartis and Lucentis marketing partner Roche have been battling Bayer in the wet AMD market for years, but the company hopes to make headway with recent launch Beovu as patent protection for Lucentis is expiring this year in the US and in 2022 in Europe.

Novartis earned $2 billion from Lucentis last year, while Roche – which sells it in the US – made $1.8 billion from the drug. Eylea was the market leader with Regeneron recording US sales of $4.6 billion in 2019, while Bayer posted $2.5 billion.

Beovu hasn’t really taken off yet, with sales of just over $150 million in the first nine months of the year, impacted by the pandemic but also because there have been reported of patients experiencing retinal vasculitis after being treated with the drug following its launch in the US in 2019.

Market research company GlobalData still thinks Beovu will become a blockbuster with peak revenues of $3.6 billion in 2028, when it expects the total wet AMD market in eight top pharma markets – the US, France, Germany, Italy, Spain, UK, Japan, China, and Australia – to reach $18.7 billion.

The post Novartis taps smartpatient for app to support wet AMD patients appeared first on .

PharmaShots Weekly Snapshot (Nov 16-20, 2020)

Eli Lilly and Incyte Receive FDA’s EUA for Baricitinib + Remdesivir to Treat Hospitalized Patients with COVID-19

Published: Nov 20,2020 | Tags: baricitinib, COVID-19, Eli Lilly, Emergency Use Authorization, FDA’s, Incyte, receives, Remdesivir

Novartis Signs a License Agreement with Mesoblast to Develop and Commercialize Remestemcel-L for ARDS

Published: Nov 20,2020 | Tags: Agreement, ARDS, Commercialize, Develop, Manufacture, Mesoblast, Novartis, Remestemcel-L, Signs, Treatment

Alvotech Reports the US FDA and EMA’s Acceptance of AVT02 Proposed Biosimilar to Humira (adalimumab)

Published: Nov 20,2020 | Tags: (adalimumab), Alvotech, AVT-301 Study, AVT-GL-101, AVT02, Chronic Plaque Psoriasis, EMA, Humira, Proposed Biosimilar, Regulatory Applications, Submits, Us FDA

Lilly Signs Agreement with Ypsomed to Advance an Automated Insulin Delivery System for People with Diabetes

Published: Nov 20, 2020 | Tags: Lilly, Signs, Agreement, Ypsomed, Advance, Automated Insulin Delivery System, People, Diabetes

Pfizer And LianBio Collaborate to Expand the Development of Novel Therapeutics in Greater China

Published: Nov 20, 2020 | Tags: Pfizer, LianBio, Collaborate, Expand, Development, Novel Therapeutics, Greater China

AstraZenca’s Imfinzi (durvalumab) Receives the US FDA’s Approval for Less-Frequent Fixed-Dose Use

Published: Nov 20,2020 | Tags: AstraZenca, CASPIAN Study, durvalumab, Imfinzi, P-lll, PACIFIC, US FDA’s

Chiesi’s Bronchitol (mannitol) Inhalation Powder Receives the US FDA’s Approval for Cystic Fibrosis

Published: Nov 19, 2020 | Tags: approval, Bronchitol, Chiesi, Cystic Fibrosis, Inhalation, Mannitol, Powder, Pulmonary, receives, US FDA

Lucira’s All-In-One Test Kit Receives the US FDA’s EUA as the First COVID-19 Test for Self-Testing at Home

Published: Nov 19, 2020 | Tags: Authorization, COVID-19, First, Home, Lucira, Lucira Health, Molecular, Prescription, receives, Test, Us FDA

Bayer to Fund Five New Startup Companies as Part of G4A Digital Health Partnerships Program

Published: Nov 19, 2020 | Tags: Bayer, Collaborate, Developed, G4A Digital Health, Healthcare Solutions, Integrated

ViiV’s PROgress Study Demonstrates Inclusion of PROs into Clinical Practice Can Improve HIV Care

Published: Nov 19, 2020 | Tags: Progress, reports, results, study, ViiV Healthcare

Pear Therapeutics Launches Somryst Insomnia App Via an End-to-End Virtual Care Experience

Published: Nov 19, 2020 | Tags: Chronic Insomnia, Launches, Pear Therapeutics, Somryst

Pfizer and BioNTech’s BNT162b2 Demonstrates 95% Efficacy in Preventing COVID-19

Published: Nov 19, 2020 | Tags: 95%, BioNTech, BNT162b2, COVID-19, Demonstrates, Efficacy, Pfizer, Preventing

Sanofi’s Supemtek (quadrivalent recombinant influenza vaccine) Receives the EC’s Approval to Prevent Influenza

Published: Nov 19, 2020 | Tags: EC’s, Influenza, Marketing Authorization, patients, quadrivalent recombinant influenza vaccine, receives, Sanofi, Supemtek

Samsung Bioepis and Biogen Announces FDA Filing Acceptance of Lucentis’ Biosimilar, SB11 for Retinal Vascular Disorders

Published: Nov 18,2020 | Tags: Acceptance, Biogen, Biosimilar, FDA Filing, Lucentis, ranibizumab, Retinal Vascular Disorders, Samsung Bioepis, SB11

BioMarin Pharmaceutical Signs an Agreement with Deep Genomics on Advancing Programs Identified Using Artificial Intelligence

Published: Nov 18, 2020 | Tags: Advancing, Agreement, Artificial Intelligence, BioMarin Pharmaceutical, Deep Genomics, Identified, Programs, Signs, Using

Pfizer Launches US Pilot Programme for Delivery and Distribution of COVID-19 Vaccine, BNT162b2

Published: Nov 18, 2020 | Tags: 4, COVID-19, Delivery, Deployment, Immunization, Pfizer, Pilot, Program, states, Updates, US,

Sanofi’s Avalglucosidase alfa Receives US FDA’s Priority Review as Enzyme Replacement Therapy for Pompe Disease

Published: Nov 18, 2020 | Tags: Avalglucosidase-alfa, BLA, Enzyme Replacement Therapy, Pompe disease, Priority Review, receives, Sanofi, US, FDA

ViiV Healthcare’s Cabotegravir Receives US FDA’s Breakthrough Therapy Designation for HIV Prevention

Published: Nov 18,2020 | Tags: Breakthrough, Cabotegravir, Designation, HIV, receives, therapy, Us FDA, ViiV Healthcare

Bayer’s Finerenone Demonstrates Positive Outcomes in Patients with Chronic Kidney Disease and Type 2 Diabetes

Published: Nov 18,2020 | Tags: BAY 94-8862, Bayer, Cardiovascular Disease, Chronic Kidney Disease, FIDELIO-DKD Study, Finerenone, Inflammatory, Type 2 Diabetes

QBiotics’ Stelfonta (tigilanol tiglate) Receives the US FDA’s Approval as the First Treatment for Non-Metastatic MCT in Dogs

Published: Nov 17, 2020 | Tags: (tigilanol tiglate injection), Non-Metastatic Mast Cell Tumors, QBiotics Group, receives, Stelfonta, US FDA’s Approval

Johnson & Johnson Initiates Second Global P-III Study of its COVID-19 Vaccine

Published: Nov 17, 2020 | Tags: COVID-19, ENSEMBLE, ENSEMBLE-2 Study, Initiates, Johnson & Johnson, P-lll

Roche Signs a License Agreement with Lead Pharma to Develop Oral Therapies for Immune-Mediated Diseases

Published: Nov 17,2020 | Tags: Develop, Immune Mediated Diseases, Lead Pharma, License Agreement, Research Collaboration, Roche, Signs, Small Oral Molecules

Zymeworks and ALX Oncology Collaborate to Evaluate Zanidatamab + ALX148 for Advanced HER2‑Expressing Breast Cancer

Published: Nov 17,2020 | Tags: Advanced, ALX Oncology, ALX148, Breast Cancer, Collaborate, Evaluate, HER2‑Expressing, Zanidatamab, Zymeworks

Moderna’s mRNA-1273 Demonstrates 94.5% Efficacy in Preventing Symptomatic COVID-19

Published: Nov 17, 2020 | Tags: COVE Study, COVID-19, Interim Analysis, Moderna, mRNA-1273, P-lll, reports, results

Bharat Biotech Initiates P-III Study for Covaxin Against COVID-19

Published: Nov 17,2020 | Tags: Against, Bharat Biotech, Covaxin, COVID-19, Initiates, P-III, study

Microsoft Collaborates with Twist and Illumina to Advance Data Storage in DNA

Published: Nov 16, 2020 | Tags: advance, Collaborates, Data Storage, DNA, Illumina, Microsoft, Twist

J&J and US Government Amends their Agreement for the Next Phase of COVID-19 Vaccine Development

Published: Nov 16, 2020 | Tags: Agreement, Candidate, Covid-19 Vaccine, Development, Expand, J&J, U.S. Department of Health & Human Services

Eisai’s Fycompa (perampanel) Receives EC’s Approval for Expanded Indication in Pediatric Patients with POS and PGTCS

Published: Nov 16, 2020 | Tags: Eisai’s, EU’s Approval, Fycompa, perampanel, PGTCS, POS, receives

Roche’s Xofluza (baloxavir marboxil) Receives CHMP’s Recommendation for Approval to Treat Influenza

Published: Nov 16, 2020 | Tags: baloxavir marboxil, EU’s Approval, Influenza, receives, Roche, Xofluza

Eli Lilly Signs a License Agreement with Seed Therapeutics for Protein Degradation-Based Therapies

Published: Nov 16, 2020 | Tags: Eli Lilly, License Agreement, Protein Degradation-Based Therapies, Seed Therapeutics, Signs

Henlius Report the NMPA’s Acceptance of HLX15 (biosimilar, Daratumumab) to Treat Multiple Myeloma

Published: Nov 16, 2020 | Tags: (biosimilar, Acceptance, daratumumab, Henlius, HLX15, Multiple Myeloma, NMPA, Report, Treat

Related Post: PharmaShots Weekly Snapshots (Nov 09-13, 2020)

The post PharmaShots Weekly Snapshot (Nov 16-20, 2020) first appeared on PharmaShots.

Novartis Signs a License Agreement with Mesoblast to Develop and Commercialize Remestemcel-L for ARDS

Shots:

  • Mesoblast to receive $25M up front and $25M as equity investment with additional payments and royalties on achievement of development, regulatory and commercial milestones
  • Novartis to acquire the exclusive WW rights to develop, commercialize & manufacture remestemcel-L for ARDS & access to a cell-therapy based platform with WW rights to a range of potential indications. Novartis has the option to distribute remestemcel-L for GVHD (outside Japan)
  • Both parties have rights to co-fund development & commercialization for other non-respiratory indications. Remestemcel-L is currently being studied in COVID-19-related ARDS in an ongoing P-III study while Novartis plans to initiate a P-III study in non-COVID-19-related ARDS

Click here ­to­ read full press release/ article | Ref: Novartis | Image: Market Watch

The post Novartis Signs a License Agreement with Mesoblast to Develop and Commercialize Remestemcel-L for ARDS first appeared on PharmaShots.

FDA begins review of Samsung Bioepis/Biogen’s Lucentis biosimilar

Novartis/Genentech’s eye drug Lucentis could be the next big blockbuster to face competition from cheaper biosimilars after its US patent expired this year – and Samsung Bioepis and Biogen are closing in after the FDA accepted a filing for their cut-price rival.

Lucentis (ranibizumab) was first FDA approved in 2006 for wet age-related macular degeneration (wet AMD) and has picked up approvals in related eye conditions ever since, although its patent expired in June.

But it has been a source of controversy – it works by attacking the rogue blood vessels that build up in the retina that are the root cause of wet AMD, something that Roche’s Avastin (bevacizumab) cancer drug can do in an off-label use at a fraction of the price.

Because Roche has never applied for Avastin to be used in wet AMD, clinics in the US have had to choose between the peace of mind offered by the regulatory process and Lucentis’ higher price tag, or the unapproved off-label formulation of Avastin at a lower price.

Samsung Bioepis and Biogen are among a gang of biosimilar developers who want to change this situation and the FDA has just accepted a filing for their potential contender known as SB11.

The European Medicines Agency already began its review of SB11 last month and if approved it will be added to a portfolio of other drugs already marketed by Samsung Bioepis.

Samsung Bioepis, a joint venture between the Korean tech firm and Biogen, last year struck a new marketing agreement with Biogen for two ophthalmology biosimilar candidates, SB11 (ranibizumab) and SB15 (aflibercept), in the US, Canada, Europe, Japan and Australia.

Other potential Lucentis biosimilars could come from Hospira and Pfizer or Formycon/Bioeq, who have potential biosimilars nearing the end of clinical development.

Biosimilars are near-copies of complex biologic drugs grown in cells, that have been rigorously analysed and tested in trials showing that they have the same safety and efficacy profile as the originator drug.

Because the approval process is more complicated and the products themselves are expensive to produce, biosimilars are not sold at the rock-bottom prices of generics.

But they are still sold at a considerable discount compared with the originators and could save billions of dollars in healthcare costs in the coming years.

 

The post FDA begins review of Samsung Bioepis/Biogen’s Lucentis biosimilar appeared first on .

NICE backs Lilly’s Emgality for migraine, adding pressure on Novartis rival

UK cost-effectiveness agency NICE has said that Eli Lilly’s Emgality can be made available through the NHS for migraine prevention, the second drug in the CGRP inhibitor class to achieve that milestone.

The decision means that with two CGRP antibodies now cleared for migraine prevention, the first drug in the class to be approved in Europe – Novartis’ Aimovig (erenumab) – has fallen further behind its rivals in getting access to the UK market.

NICE has backed Emgality (galcanezumab) as a once-monthly injection to prevent migraine attacks in people with episodic or chronic migraine who suffer at least four days with a migraine headache per month, and who have tried at least three prior preventative medicines.

That puts Emgality ahead of Teva’s Ajovy (fremanezumab), which picked up a positive opinion from NICE earlier this year but is only recommended for use in chronic migraine sufferers who have 15 or more headache days a month for more than three months, with at least eight of those having features of migraine.

It also puts Lilly’s drug ahead of Aimovig, which has been rejected twice by NICE although the agency has agreed to take another look at the application after an appeals panel ruled that its technology appraisal committee had failed to consider all of the evidence about the cost-effectiveness for the drug.

NICE said Ajovy was an option for around 10,000 people in the UK in guidance issued in June, but Lilly says many more patients are eligible for its drug – around 144,000 people with episodic migraine and 59,000 people with chronic migraine.

The decision is based on trials comparing Emgality with placebo which showed that the antibody halved the number of monthly migraine headache days for up to 40% of adults with migraine who had previously tried three or more prior medicines, such as Allergan’s Botox (botulinum toxin type A) or topiramate.

Gemma Jolly of medical charity the Migraine Trust said NICE’s recommendation is “wonderful news for people living with this very painful and debilitating neurological condition [as] both chronic and episodic migraine patients across England and Wales will be able to access an effective drug on the NHS.”

The CGRP inhibitors have performed well in clinical trials, but so far commercial success has been limited, despite blockbuster sales predictions ahead of their approval.

First-to-market Aimovig generated sales of $108 million in the first nine months of 2020 for Novartis, which records ex-US sales, while Amgen booked $274 million from the drug in the US in the same period.

Aimovig is said to be the most prescribed anti-CGRP drug worldwide with more than 480,000 patients prescribed the drug worldwide. In the same period, Lilly reported sales of $253 million for Emgality, and Teva made $98 million from Ajovy.

Novartis is hoping for a bounce to Aimovig sales from the HER-MES trial reported earlier this month, which showed it was more effective than topiramate – a go-to oral therapy for people with chronic migraine – in a head-to-head trial.

There’s more competition jostling for position however, following the approval of Lundbeck’s Vyepti (eptinezumab), an intravenous drug that only needs to be administered four times a year.

Lilly has a real opportunity to build momentum behind Emgality in England and Wales, but will have to wait until next year before it hears from NICE’s counterpart in Scotland, the Scottish Medicines Consortium (SMC). Aimovig was cleared for use by NHS Scotland last year, with Ajovy given a green light in January 2020.

The post NICE backs Lilly’s Emgality for migraine, adding pressure on Novartis rival appeared first on .

PharmaShots Weekly Snapshots (Nov 09-13, 2020)

Qiagen Launches Portable Digital SARS-CoV-2 Antigen Test in the US

Published: Nov 13,2020 | Tags: Antigen Test, Digital, Launches, Portable, Qiagen, SARS-CoV-2, US

GSK and Medicago Initiate P-II/III Study of its Plant-Derived COVID-19 Vaccine

Published: Nov 13,2020 | Tags: COVID-19, GSK, Initiate, Medicago, P-II/III, Plant- Derived study, vaccine

BD Acquires the Medical Business Assets of CUBEX

Published: Nov 13, 2020 | Tags: BD, Acquires, Medical Business, Assets, CUBEX

Health2Sync Divulges Benefits of Integrating Fitbit Wearable Devices into Diabetes Care in Taiwan

Published: Nov 13,2020 | Tags: Health2Sync, Divulges, Benefits, Integrating, Fitbit, Wearable Devices, Diabetes, Care, Taiwan

UCB Acquires Handl Therapeutics to Augment its Gene Therapy Portfolio

 Published: Nov 13,2020 | Tags: UCB, Acquires, Handl Therapeutics, Augment, Gene Therapy,  Portfolio

Medtronic Launches InPen Integrated with CGM Data for People with Diabetes on MDI

Published: Nov 13,2020 | Tags: CGM Data, Diabetes, InPen, Integrated, Launches, MDI, Medtronic

Qiagen Collaborate with TScan to Develop T Cell-Based COVID-19 Test

Published: Nov 12,2020 | Tags: COVID-19, Exclusive, License Agreement, Option, Qiagen, Research, Signs, TScan Therapeutics

AstraZenca’s Calquence (acalabrutinib) Fails to Meet its Primary Endpoint in P-II Studies for COVID-19

Published: Nov 12,2020 | Tags: acalabrutinib, AstraZenca, CALAVI, Calquence, COVID-19, P-ll Study, Report, Respiratory Complications, results

Pfizer and BioNTech to Supply EU with up to 200M Doses of BNT162B2 Against COVID-19

Published: Nov 12,2020 | Tags: Agreement, BioNTech, BNT162b2, EU, European Commission, m-RNA Vaccine, Pfizer, Signs, Supply

Pfizer Reports Results of Abrocitinib in Fifth P-lll JADE REGIMEN Across Different Dosing Regimens

Published: Nov 12,2020 | Tags: Abrocitinib, JADE REGIMEN Study, moderate to severe Atopic Dermatitis (AD), P-lll, Pfizer, Positive, Report, results

Moderna Report Results of mRNA-4157 + Keytruda in Interim P-l Study for HNSCC and MSS-CRC

Published: Nov 12,2020 | Tags: HNSCC, Interim, Moderna, mRNA-4157, P-l study, pembrolizumab, Report, results, SITC 2020

J&J Resumes all Clinical Trial of its COVID-19 Vaccine in the EU

Published: Nov 12,2020 | Tags: Clinical Trial, COVID-19, EU, J&J, Resumes, vaccine

CureVac Publishes Results of CVnCoV in Interim P-l Study for COVID-19

Published: Nov 11,2020 | Tags: COVID-19, CureVac, CVnCoV, Interim, P-l study, reports, results

Prestige Signs an Exclusive Agreement with Teva to Commercialize Tuznue (biosimilar, trastuzumab) in Israel

Published: Nov 11,2020 | Tags: Agreement, Biosimilar, Commercialize, Israel, Prestige, Signs, Teva, trastuzumab, Tuznue

NightWare Receives the US FDA’s Approval for the First Medical Device to Stop NightMAres Related to PTSD

Published: Nov 11,2020 | Tags: Designed, Marketing, New Device, Nightmare Disorder, Permit, PTSD, Reduce, Sleep, US FDA

Samsung Bioepis Initiates P-I Study of SB16 Proposed Biosimilar to Prolia (denosumab)

Published: Nov 11,2020 | Tags: (Denosumab), Initiates, P-I study, Prolia, Proposed Biosimilar, Samsung Bioepis, SB16

Abbott Launches IonicRF Generator for Patients with Chronic Pain in the US

Published: Nov 11,2020 | Tags: Abbott, Chronic, Generator, IonicRF, Launch, Pain, patients, US, Use

Henlius Reports First Patients Dosing in P-I Study of HLX14 (denosumab, biosimilar)

Published: Nov 11,2020 | Tags: Henlius, Reports, First, Patient Dosing, P-l Study, HLX14, denosumab, biosimilar

Novavax Receives the US FDA’s Fast Track Designation for NVX-CoV2373 to Treat COVID-19

Published: Nov 10, 2020 | Tags: COVID-19, Fast Track Designation, Novavax, NVX-CoV2373, receives, Treat, US FDA

AstraZeneca and Amgen Report Results of Tezepelumab in P-III NAVIGATOR for Asthma

Published: Nov 10,2020 | Tags: Amgen, Asthma, AstraZeneca, NAVIGATOR, P-III, patients, Positive, reports, results, Severe, Tezepelumab, Trial, Uncontrolled

Lilly’s Bamlanivimab (LY-CoV555) Receives the US FDA’s EUA for the Treatment of Recently Diagnosed COVID-19

Published: Nov 10,2020 | Tags: Bamlanivimab, COVID-19, Diagnosed, EUA, Lilly, LY-CoV555, receives, recently, Treatment, Us FDA

Pfizer and BioNTech’s BNT16`2b2 Demonstrates 90% Efficacy in Preventing COVID-19

Published: Nov 10,2020 | Tags: Against, BioNTech, BNT162b2, Clinical, Pfizer, reports, study

AstraZeneca’s Calquence (acalabrutinib) Receives EU’s Approval for Chronic Lymphocytic Leukaemia

Published: Nov 10,2020 | Tags: (acalabrutinib), AstraZeneca’s, Calquence, Chronic Lymphocytic Leukaemia (CLL), EU’s Approval, receives

Bayer Reports Regulatory Submission of Finerenone (BAY 94-8862) to the US and EU for CKD and T2D

Published: Nov 10,2020 | Tags: (BAY 94-8862), Bayer, EMA, Finerenone, Regulatory Applications, Submits, Treat Chronic Kidney Disease (CKD), Type 2 Diabetes (T2D), Us FDA

Alvotech and Cipla Collaborate to Ensure Access to Biosimilars in South Africa

Published: Nov 9,2020 | Tags: Access, Alvotech, Biosimilars, Cipla, Ensure, Exclusive Partnership, Expand, South Africa

Novartis’ Ilaris (canakinumab) Fails to Meet its Primary Endpoints in P-lll Study for COVID-19 Pneumonia and CRS

Published: Nov 9,2020 | Tags: (canakinumab), CAN-COVID Trial, Covid-19, Pneumonia, Cytokine Release Syndrome (CRS), Ilaris, Novartis, P-lll, Report, results

Eisai Reports Results of Lenvima (lenvatinib) + Everolimus in P-II 218 Study for Advanced Renal Cell Carcinoma

Published: Nov 9,2020 | Tags: 2020, 218, Advanced, Renal, Cell, Carcinoma, Eisai, Everolimus, IKCS, lenvatinib, Lenvima, P-II, Presents, results, study

Celltrion Reports Results of CT-P59 in P-I Study for COVID-19

Published: Nov 9, 2020 | Tags: 2020, Celltrion, Clinical, Conference, CT-P59, Fall, Korean Society of Infectious Diseases, P-I, Presents, results, Trial

The US FDA’s Advisory Panel Slams Biogen’s Aducanumab for Alzheimer’s Disease

Published: Nov 9, 2020 | Tags: aducanumab, Advisory, Biogen, Committee, EMERGE, ENGAGE, Meeting, P-III, reports, study, Updates, Us FDA

Merck and Transcenta Collaborate to Implement Continuous Manufacturing for Protein Therapeutics

Published: Nov 9, 2020 | Tags: Collaborate, Continuous Manufacturing, Implement, Merck, Protein Therapeutics, Transcenta

Related Post: PharmaShots Weekly Snapshot (Nov 02-06, 2020)

The post PharmaShots Weekly Snapshots (Nov 09-13, 2020) first appeared on PharmaShots.

Novartis’ Ilaris (canakinumab) Fails to Meet its Primary Endpoints in P-lll Study for COVID-19 Pneumonia and CRS

Shots:

  • The P-lll CAN-COVID trial involves assessing Ilaris (canakinumab) + SOC vs PBO + SoC in 454 patients aged 18-98yrs. with COVID-19 pneumonia and cytokine release syndrome CRS, with its expected full results in early 2021
  • Result: The trial fails to meet its 1EPs of survival without the need for mechanical ventilation up to day29 (88.8% vs 85.7%) and did not meet its 2EPs of COVID-19-related mortality up to 4 wks. (4.9% vs 7.2%)
  • Canakinumab is mAb that binds to and neutralizes (IL-1β), blocking its action. Additionally, P-III trial for ruxolitinib in COVID-19 is ongoing, with preliminary results expected by end of 2020

Click here ­to­ read full press release/ article | Ref: Novartis | Image: US News Health

The post Novartis’ Ilaris (canakinumab) Fails to Meet its Primary Endpoints in P-lll Study for COVID-19 Pneumonia and CRS first appeared on PharmaShots.

PharmaShots Weekly Snapshot (Nov 02-06, 2020)

AstraZeneca’s Brilinta (ticagrelor) Receives the US FDA’s Approval to Reduce the Risk of Stroke in Patients with an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack

Published: Nov 6, 2020 | Tags: AstraZeneca, Brilinta, ticagrelor, Receives, US FDA, Approval, Acute, High,Risk, Transient, Ischaemic, Stroke

Novo Nordisk to Acquire Emisphere Technologies for $1.8B

Published: Nov 6, 2020 | Tags: Novo Nordisk, Acquire, Emisphere Technologies, $1.8B

AstraZeneca’s Forxiga (dapagliflozin) Receives EC’s Approval for Heart Failure

Published: Nov 5, 2020 | Tags: AstraZeneca’s, Forxiga, (dapagliflozin), Receives, EU, Approval, Heart Failure

AstraZeneca and MSD’s Lynparza (olaparib) Receive EU’s Approval as 1L Maintenance Treatment for HRD-Positive Advanced Ovarian Cancer

Published: Nov 5, 2020 | Tags: AstraZeneca, MSD, Lynparza, Olaparib, Receives, EU, Approved, HRD, Positive, Advanced, Ovarian, Cancer

Merck KGaA Collaborates with Iktos to Deploy AI in New Drug Design

Published: Nov 5, 2020 | Tags: Iktos, Signs, Agreement, Merck, KGaA, AI, New, Drug, Design

Formycon Reports BLA Resubmission Strategy for FYB201 (biosimilar, ranibizumab)

Published: Nov 5, 2020 | Tags: Formycon, Reports, BLA, Resubmission, Strategy, Lucentis, Biosimilar, FYB201

Novartis Reports Results of Cosentyx (secukinumab) in P-IIIb ULTIMATE Study for Psoriatic Arthritis

Published: Nov 5, 2020 | Tags: Cosentyx, Novartis, P-IIIb, patients, Psoriatic Arthritis, reports, results, secukinumab, study, ULTIMATE

Merck to Acquire VelosBio for $2.75B

Published: Nov 5, 2020 | Tags: $2.75B, Acquire, Merck, Oncology Pipeline, VelosBio

Innovent and Lilly Report Results of Tyvyt (sintilimab) in Seven Clinical Studies to be Presented at the ESMO ASIA Congress 2020

Published: Nov 5, 2020 | Tags: 2020, 7, Asia, Clinical, Congress, ESMO, Injection, Innovent, Lilly, Presents, results, Sintilimab, Studies, Tyvyt

Coloplast Acquires Nine Continents Medical

Published: Nov 4, 2020 | Tags: Coloplast, Acquires, Nine Continents Medical

Novavax Collaborates with Commonwealth of Australia to Supply 40M doses of NVX-CoV2373 for COVID-19

Published: Nov 4, 2020 | Tags: Novavax, Collaborates, Commonwealth, Australia, Supply, 40M, Doses, NVX-coV2373, COVID-19

BioInvent Presents New Clinical and Preclinical Data of BI-1206 at ASH Annual Meeting

Published: Nov 5, 2020 | Tags: ASH Annual Meeting, BI-1206, BioInvent, Follicular Lymphoma Mantle Cell Lymphoma, Marginal Zone Lymphoma, P-l/lla Study, reports, results

Jounce Stops Enrollment in P-II EMERGE Study Evaluating Vopratelimab for Lung Cancer

Published: Nov 4,2020 | Tags: Jounce Therapeutics, P-II EMERGE trial, Program, reports, Update, Vopratelimab

Biomarin Reports the US FDA’s Acceptance of Vosoritide’s NDA to Treat Children with Achondroplasia

Published: Nov 4, 2020 | Tags: Acceptance, Achondroplasia Regulatory, BioMarin, Children, FDA, NDA, reports, US, Vosoritide

CEPI to Invest ~$328M in Clover’s COVID-19 Vaccine Candidate

Published: Nov 3, 2020 | Tags: CEPI, Clover Biopharmaceuticals, Covid-19 Vaccine, Expand, Fund, Partnership

Abbott to Launch its Cardiac Mapping Platform in Europe and Australia

Published: Nov 2,2020 | Tags: Abbott, approval, CE Mark, EnSite X EP System, receives, TGA

BMS’ Deucravacitinib (BMS-986165) Demonstrate Superiority Over Amgen’ Otezla (apremilast) in P-III POETYK PSO-1 Study for Plaque Psoriasis

Published: Nov 4,2020 | Tags: BMS, BMS-986165, Deucravacitinib, Moderate, P-III, patients, Plaque, POETYK PSO-1, Positive, Psoriasis, reports, results, Severe, study

Boston Scientific’s Ranger DCB Receives the US FDA’s Approval for Peripheral Artery Disease in the SFA and PPA 

Published: Nov 4,2020 | Tags: approval, Boston Scientific, DCB, patients, Peripheral Artery Disease, PPA, Range, receives, SFA, Treatment, Us FDA

Novartis Reports Results of Kisqali (ribociclib) in P-III MONALEESA-7 Study in Women with HR+/HER2- Advanced Breast Cancer

Published: Nov 3,2020 | Tags: Advanced, breast, Cancer, HR+/HER2, Kisqali, MONALEESA-7, Novartis, P-III, reports, results, ribociclib, study, Women

Tetra Therapeutics Reports Positive Results of BPN14770 in P-II Study for Fragile X Syndrome

Published: Nov 3, 2020 | Tags: BPN14770, FXS, P-II, patients, Positive, reports, results, study, Tetra Therapeutics

Roche’s Tecentriq (atezolizumab) + Avastin (bevacizumab) Receive the EC’s Approval for Unresectable Hepatocellular Carcinoma

Published: Nov 3, 2020 | Tags: (atezolizumab), (bevacizumab), Aavastin, EU Approval Unresectable Hepatocellular Carcinoma (HCC), receives, Roche’s, Tecentriq

Celltrion Presents Results of CT-P17 (biosimilar, adalimumab) in P-III Study for RA at ACR 2020

Published: Nov 3, 2020 | Tags: 2020, ACR, Celltrion Healthcare, Convergence, CT-P17, P-III, Positive, Presents, RA, results, study, Treatment

Janssen Reports sNDA Submission of Paliperidone Palmitate 6-Month (PP6M) to the US FDA for Schizophrenia

Published: Nov 3, 2020 | Tags: (PP6M), Invega Sustenna, Invega Trinza, Janssen, NDA submission, reports, Us FDA

AstraZeneca and Fusion Collaborate to Develop and Commercialize Radiopharmaceuticals and Combination Therapies for Cancer

Published: Nov 3, 2020 | Tags: AstraZeneca, Cancer, Collaborate, Combination Therapies, Commercialize, Develop, Fusion, Next-Generation Radiopharmaceuticals

Novartis Reports Results of Aimovig (erenumab) in P-lV Study for Episodic and Chronic Migraine

Published: Nov 2, 2020 | Tags: Aimovig, Episodic and Chronic Migraine (HER-MES), erenumab, Novartis, P-lV Study, positive results, Report

Sun Pharma Reports Five Year Results of Ilumya (tildrakizumab-asmn) in P-III Studies for Moderate-to-Severe Plaque Psoriasis

Published: Nov 2, 2020 | Tags: 5-year, Ilumya, Moderate, P-III, patients, reports, results, reSURFACE 1, reSURFACE 2, Severe, Studies, Sun Pharma, tildrakizumab-asmn

 Regeneron Pauses Dosing of Garetosmab (REGN2477) in P-II LUMINA-1 Study for Fibrodysplasia Ossificans Progressiva

Published: Nov 2, 2020 | Tags: Fibrodysplasia Ossificans Progressiva, Garetosmab, LUMINA-1 Trial, P-ll, patients, Regeneron, REGN2477, Report, results

UCB Reports Results of Bimekizumab in P-III BE SURE Study for Moderate-to-Severe Psoriasis

Published: Nov 2, 2020 | Tags: BE SURE, Bimekizumab, Moderate, P-III, patients, Psoriasis, reports, results, Severe, study, UCB

Sanofi to Acquire Kiadis for ~$358M

Published: Nov 2, 2020 | Tags: $358.76M, Acquire, Kiadis, Offers, Sanofi

Medtronic Expands ENT Portfolio with the Acquisition of Ai Biomed and the Approval of NIM Vital Nerve Monitoring System

Published: Nov 2, 2020 | Tags: Acquires, Ai Biomed Corp., ENT Portfolio, Medtronic’s, NIM Vital, Parathyroid Detection System, receives, US FDA’s Approval

Related Post: PharmaShots Weekly Snapshot (Oct 26 – 30, 2020)

The post PharmaShots Weekly Snapshot (Nov 02-06, 2020) first appeared on PharmaShots.

Novartis’ Ilaris fails in late-stage COVID-19 trial

Novartis’ Ilaris (canakinumab) has failed to produce results in a phase 3 trial, which tested whether it could improve COVID-19 patients’ survival chances without need for mechanical ventilation.

The company is trying to repurpose the drug used in rare inflammatory diseases such as juvenile arthritis for COVID-19, to see if it could relieve the extreme immune reaction that can prove fatal after infection with coronavirus.

But results from the CAN-COVID trial showed that Ilaris also missed an important secondary goal of reduced COVID-19 mortality compared with standard therapy.

In the trial involving 454 patients in the US, Russia and Europe, the primary endpoint of survival without the need for mechanical ventilation was 88.8% for canakinumab plus standard care compared with 85.7% for placebo plus standard care.

The key secondary endpoint was to reduce the COVID-19-related death rate during the four week period after trial treatment.

While the data trended in Ilaris’ favour against both targets, the effect seen was not marked enough to be statistically significant.

Novartis noted that the results from this trial do not affect Ilaris’ licensed indications or other trials and the safety profile was comparable to placebo plus standard of care.

An interim analysis will be submitted to a peer-reviewed journal in the coming weeks.

The company said the focus in COVID-19 moves to Jakavi/Jakafi (ruxolitinib), which is in a phase 3 trial and is another attempt to repurpose an already approved drug – Jakafi is already approved in indications including myelofibrosis.

Novartis is also working with Molecular Partners to develop therapies based on genetically engineered proteins known as DARPins.

These are small proteins that are created in the lab but mimic the effect of antibodies and could be used to neutralise the SARS-CoV-2 coronavirus that causes COVID-19.

There have been countless efforts to repurpose existing drugs to fight COVID-19, with the most successful arguably being dexamethasone.

The cheap steroid has been shown to reduce inflammation caused by the disease in the UK’s large RECOVERY trial, which is testing several already licensed drugs against COVID-19.

 

 

 

The post Novartis’ Ilaris fails in late-stage COVID-19 trial appeared first on .

Novartis Reports Results of Cosentyx (secukinumab) in P-IIIb ULTIMATE Study for Psoriatic Arthritis

Shots:

  • The P-IIIb ULTIMATE study involves assessing Cosentyx (300/150mg) vs PBO weekly for a mos. with treatment starting @4wks., followed by a once-a-month dose for the next 11mos. in 166 biologic-naïve patients in a ratio (1:1) with active PsA
  • The study reduction of synovitis @12wks. with an early improvement observed as 1wk., ACR20 (68% vs 34%); ACR50 (46% vs 9%,) & enthesitis (change in SPARCC, -2.4 vs -1.7); safety profile was consistent with previous studies @12wks.
  • Cosentyx is the first & only fully-human biologic that directly inhibits IL-17A. Novartis anticipates disclosing full 24-week data from the ongoing ULTIMATE trial at the EULAR in 2021 and final analysis at ACR 2021

Click here to­ read the full press release/ article | Ref: Novartis | Image: GMP News

The post Novartis Reports Results of Cosentyx (secukinumab) in P-IIIb ULTIMATE Study for Psoriatic Arthritis first appeared on PharmaShots.

Novartis’ Aimovig tops topiramate in migraine face-off

Novartis’ injectable migraine prevention antibody Aimovig has been shown to be more effective than topiramate – a go-to oral therapy for people with chronic migraine – in a head-to-head trial.

The HER-MES trial found that Aimovig (erenumab) was more effective at preventing migraine attacks and also better tolerated than topiramate, a generic epilepsy drug which is known to have side effects like sleepiness, dizziness, diarrhoea and nausea.

In the 777-patient study, fewer patients on Novartis’ drug discontinued treatment due to side effects, while more of them met the objective of a 50% reduction in the number of days in a month they had a migraine compared to high-dose topiramate.

Topiramate also needs to be taken twice a day, while Aimovig is given as an injection once a month and is available in a self-injector pen device. Both drugs can take up to three months for their effect on migraine prevention to fully kick in.

Novartis recorded Aimovig sales of $108 million in the first nine months of 2020, a rise of 44% on the same period of 2019, and says it is the most prescribed drug in the CGRP inhibitor class with 480,000 patients using it worldwide.

Quarterly sales have however fallen from a strong launch in 2018, and the drug can’t seem to generate the momentum needed to meet blockbuster sales expectations voiced during its development.

Part of that is the entry into the market of CGRP rivals, with three injectable drugs (Teva’s Ajovy and Eli Lilly’s Emgality) and one six-monthly infusion (Lundbeck’s Vyepti) now jostling for position in the migraine prevention market.

Meanwhile, two oral CGRP inhibitors – AbbVie’s Ubrelvy and BioHaven’s Nurtec – have been launched for the on-demand treatment of acute migraine attacks. These don’t compete with Aimovig and the other prevention therapies directly, but are raising the profile of the CGRP class among migraine sufferers and their doctors.

This year of course there have also been access issues caused by the coronavirus pandemic that have had a particularly big impact on neurology prescribing, as well as a continued challenge in persuading doctors to switch to the new class from older drugs like topiramate and AbbVie/Allergan’s Botox.

It’s estimated that CGRP drugs have only penetrated 15% of the migraine prevention market, and that’s why the HER-MES results are so important to Novartis.

“These results further emphasise its potential to provide significant relief from migraine with an infrequent dosing compared with the oral treatment,” said Estelle Vester-Blokland, the company’s global head of neuroscience medical affairs.

The company has exclusive rights to the sell Aimovig outside the US, where Amgen records sales, with the exception of Japan. Novartis and Amgen are however locked in a legal battle over marketing rights to the drug.

Photo by Carolina Heza on Unsplash

The post Novartis’ Aimovig tops topiramate in migraine face-off appeared first on .

Novartis Reports Results of Kisqali (ribociclib) in P-III MONALEESA-7 Study in Women with HR+/HER2- Advanced Breast Cancer

Shots:

  • The pivotal P-III MONALEESA-7 study assessing Kisqali + endocrine therapy vs PBO + endocrine therapy, in pre- & perimenopausal women with HR+/HER2- advanced or metastatic-BC
  • The study met its 2EPs of OS, demonstrating a significant improvement in OS, and is consistent for the NSAI population & across exploratory subgroups, m-OS was not reached while the median duration of follow-up was 34.6 mos.
  • Kisqali is a selective cyclin-dependent kinase inhibitor, acts by inhibiting two proteins called CDK4/6

Click here ­to­ read full press release/ article | Ref: Novartis | Image: Law

The post Novartis Reports Results of Kisqali (ribociclib) in P-III MONALEESA-7 Study in Women with HR+/HER2- Advanced Breast Cancer first appeared on PharmaShots.

Novartis Reports Results of Aimovig (erenumab) in P-lV Study for Episodic and Chronic Migraine

Shots:

  • The P-IV HER-MES study involves assessing Aimovig (erenumab 70mg and 140mg) vs topiramate in 777 patients in a ratio (1:1) with episodic or chronic migraine (≥4 migraine days/month) prior not treated with migraine prevention treatment or previously failed up to three prophylactic migraine treatments
  • The study met its 1EPs & 2EPs and had superior tolerability against topiramate, with a higher proportion of patients remaining on Aimovig than on topiramate. The therapy showed superior efficacy, with a greater proportion of patients achieving at least a 50% reduction in their MMDs
  • Aimovig is the first EMA, Swissmedic, and US FDA’s approved migraine prevention treatment designed to target CGRP-R

Click here to­ read the full press release/ article | Ref: GlobeNewswire | Image: Caixin Global

The post Novartis Reports Results of Aimovig (erenumab) in P-lV Study for Episodic and Chronic Migraine first appeared on PharmaShots.

Novartis keeps a close eye on gene therapy with Vedere Bio buy

Already a major player in gene therapy, Novartis has swooped on US startup Vedere Bio in a $280 million deal that builds its position in inherited eye diseases that can lead to blindness.

Incubated by Atlas Ventures, Cambridge, Massachusetts Vedere has been flying under the radar since it was founded in 2019 to develop adeno-associated virus (AAV) based gene therapies for ocular diseases, but didn’t escape the beady eye of Novartis.

The Swiss pharma group already sells one gene therapy for inherited retinal diseases (IRDs) – Luxturna (voretigene neparvovec) – for which it licensed ex-US rights from Spark Therapeutics (now part of Roche) in 2018.

Novartis’ big move in the gene therapy market came when it bought AveXis for $8.7 billion in the same year to add spinal muscular atrophy therapy Zolgensma (onasemnogene abeparvovec), which has made $1 billion in sales since launch last year.

Earlier this year, the group also signed a licensing deal with Dyno Therapeutics for its AAV capsid-based gene delivery technology, also focused on ocular disease which remains one of Novartis’ core drug development targets despite the spin-off of the Alcon eyecare division in 2019.

Shortly after, Novartis teamed up with Sangamo in a deal focused on the adjacent gene therapy discipline of gene silencing, targeting neurodevelopmental disorders like autism.

The Vedere acquisition includes $150 million upfront and $130 million in potential milestones, and expands Novartis position in ocular disease gene therapy with an AAV delivery platform as well as rights to light-sensing proteins that can be delivered to cells in the retina.

It also gets two preclinical-stage development projects. One focusing on IRDs – a wide range of genetic retinal disorders caused by mutations in some 250 genes that are marked by the loss of photoreceptor cells and progressive vision loss. IRDs affect around 2 million people worldwide.

The second is looking at geographic atrophy, an advanced form of ‘dry’ age-related macular degeneration (AMD) that affects around 5 million people around the world and has no approved medical treatments.

While gene therapies like Luxturna are aimed at preventing progressive vision loss, Novartis thinks it could go a step further with the Vedere platform and attempt to restore vision that has already been lost – something that the company’s scientific founders have achieved in animal models.

Combining the light-sensing proteins and AAV platform has the potential “to vastly expand the number of patients who could be treated for vision loss due to photoreceptor death,” according to the company.

When delivered to retinal cells, the proteins stimulate them to sense and transmit information to the visual processing centres in the brain, bypassing cells that have already degenerated.

The post Novartis keeps a close eye on gene therapy with Vedere Bio buy appeared first on .

Novartis Acquires Vedere Bio for $280M

Shots:

  • Vedere Bio received $150M as upfront payments and is eligible to receive up to $130M as milestones making a total deal value of $280M. The transaction closed in Sept’2020
  • The acquisition will strengthen Novartis’ footprints with the addition of lead preclinical intravitreally injected AAV gene therapy programs focused on pan-genotypic vision restoration in patients with photoreceptor-based vision loss
  • Prior to the acquisition, earlier-stage vision restoration and vision preservation assets leveraging the company’s ocular gene therapy toolbox were spun out into a newly formed entity – Vedere Bio II. The new company will operate as a wholly independent entity from Novartis and Vedere Bio

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Easier Accounting

The post Novartis Acquires Vedere Bio for 0M first appeared on PharmaShots.

Novartis Signs an Option and License Agreement with Molecular Partners to Develop Two DARPin Therapies for COVID-19

Shots:

  • Molecular Partners to receive $65.8M as up front, including equity, and will receive $164.7M as an option payment for both MP0420 and MP0423 along with royalties on sales of therapies. Novartis to get an option to in-license global rights of MP0420 and MP0423
  • During the option period, Molecular Partners will conduct a P-I study for MP0420, expected to initiate in Nov’2020, and perform all remaining preclinical work for MP0423 while Novartis will lead P-II & P-III study
  • Upon option exercise, Novartis will lead further development and commercialization activities while Molecular Partners will provide clinical supply during the development stage. MP0420 and MP0423 are potential medicines for the prevention & treatment of COVID-19, with the possibility of being manufactured at scale and the potential to bypass cold storage

Click here ­to­ read full press release/ article | Ref: Novartis | Image: M3 India

The post Novartis Signs an Option and License Agreement with Molecular Partners to Develop Two DARPin Therapies for COVID-19 first appeared on PharmaShots.

Novartis Presents Results of Iptacopan (LNP023) in P-ll Study for C3 Glomerulopathy at ASN Annual Meeting 2020

Shots:

  • The P-II study involves assessing the efficacy, safety and PK of Iptacopan (LNP023) in patients with C3G (Cohort A) and patients who have undergone a kidney transplant and have C3G recurrence (Cohort B), interim results presented at ASN 2020
  • Result: @12wks., reduction in proteinuria (49%) as measured by 24hrs. UPCR assessment; improvement in plasma C3 level; inhibit alternative complement pathway activity; stabilized renal function as assessed by eGFR
  • Iptacopan (PO) is a first-in-class reversible inhibitor of factor B and has received EMA’s PRIME designation for iptacopan in C3G and EMA’s ODD in IgAN. The therapy is in development for multiple renal conditions including C3G, IgAN, aHUS, iMN as well as in PNH which is a hematological disease

Click here ­to­ read full press release/ article | Ref: Novartis | Image: Whistleblower News Review

The post Novartis Presents Results of Iptacopan (LNP023) in P-ll Study for C3 Glomerulopathy at ASN Annual Meeting 2020 first appeared on PharmaShots.

PharmaShots Weekly Snapshot (Oct 19 – 23, 2020)

Akebia Presents Results of Vadadustat in P-lll INNO2VATE Program for Anemia Due to CKD at ASN Kidney Week

Published: Oct 23, 2020 | Tags: Akebia, Results, Vadadustat, P-lll, INNO2VATE Global Study, Anemia, Chronic Kidney Disease

Sanifit Presents Results of SNF472 for the Treatment of Vascular Calcification at ASN Kidney Week 2020

Published: Oct 22, 2020 | Tags: 2020, ASN Calcification, Kidney, reports, results, Sanifit, SNF472, Treatment, Vascular, Week

Daiichi Sankyo Initiates P-I Study of DS-1055 for Relapsed/Refractory Advanced or Metastatic Solid Tumors

Published: Oct 22,2020 | Tags: Activated, Daiichi, DS-1055, GARP, Immuno, Initiates, Oncology, P-I, Regulatory, T Cells, Targeting, therapy, Trial

UCB’s Vimpat (lacosamide) Receives CHMP’s Positive Opinion for Primary Generalized Tonic-Clonic Seizures

Published: Oct 22,2020 | Tags: CHMP’s Positive Opinion, EU Approval, lacosamide, Primary Generalised Tonic-Clonic Seizure, receives, UCB’s, Vimpat

Dicerna Presents New Interim Data of PHYOX 3 OLE Study Evaluating Nedosiran for Primary Hyperoxaluria at ASN Week 2020

Published: Oct 22,2020 | Tags: ASN Week 2020, Dicerna, Evaluating, Nedosiran, New Interim Data, PHYOX 3 OLE, Presents, Primary Hyperoxaluria, study

Gilead’s Veklury (remdesivir) Receives the US FDA’s Approval as the First Treatment for COVID-19

Published: Oct 22,2020 | Tags: COVID-19, Gilead, receives, Remdesivir, US FDA Approval, Veklury

ViiV Healthcare Present Results of Long-Acting Cabotegravir and Rilpivirine at IDWeeK 2020

Published: Oct 21, 2020 | Tags: Antiretroviral Therapy, ATLAS, ATLAS-2M, Cabenuva, Cabotegravir, COVID-19, CUSTOMIZE, FLAIR, LATTE-2, P-IIb/IIIb, POLAR, reports, Result, Rilpivirine, ViiV Healthcare

Roche Collaborates with Atea Pharmaceuticals to Develop AT-527 for COVID-19

Published: Oct 22, 2020 | Tags: AT-527, Atea Pharmaceuticals, Collaborates, COVID-19, Develop, Roche

Novartis’s Branaplam (LMI070) Receives the US FDA’s Orphan Drug Designation for Huntington’s Disease

Published: Oct 21, 2020 | Tags: Branaplam, Designation, Disease, Drug, Huntington, LMI070, Novartis, Orphan, receives, U.S.FDA

AWS and Onica Collaborate with Teva to Support its Digihaler Portfolio

Published: Oct 21, 2020 | Tags: AWS, Collaborate, Digihaler, Portfolio, Onica, Teva

GSK Presents Results of Maternal & Older Adults RSV Vaccines at IDWeek 2020

Published: Oct 21, 2020 | Tags: Adults, Candidate, Clinical, GSK, Maternal, Older, Positive, reports, results, RSV, Vaccines

Novo Nordisk Signs a License Agreement with Chugai for Antibody Engineering Technologies

Published: Oct 21, 2020 | Tags: Antibody Engineering Technologies, Chugai, License Agreement, Novo Nordisk, Signs

NeuClone Reports Positive Results of NeuLara (biosimilar, ustekinumab) in P-l Study for Autoimmune Diseases

Published: Oct 20, 2020 | Tags: Biosimilar, Crohn Disease, NeuClone, P-l Trial, Positive Result, reports, Stelara, ustekinumab

Jazz Reports Results of Xywav (calcium, magnesium, potassium, and sodium oxybates) in P-III Study for Cataplexy or EDS in Patients with Narcolepsy

Published: Oct 20, 2020 | Tags: Cataplexy, EDS, Jazz, Narcolepsy, Oral, P-III, patients, publication, reports, results, Sleep, Solution, study

Samsung Biologics Collaborates with Dinona to Develop DNP-019 for COVID-19

Published: Oct 20,2020 | Tags: Collaborates, COVID-19, Develop, Dinona, DNP-019, Samsung Biologics

Roche and Prothena to Advance Prasinezumab in P-IIb Study for Patients with Early Parkinson’s Disease

Published: Oct 21, 2020 | Tags: Advances, Clinical, Development, Disease, Late, Parkinson, Prasinezumab, Prothena, Roche, Stage, study

Lilly’s Taltz (ixekizumab) Receives Health Canada Approval for Non-Radiographic Axial Spondyloarthritis

Published: Oct 20, 2020 | Tags: Health Canada Approval, ixekizumab, Lilly, Non-Radiographic Axial Spondyloarthritis, receives, Taltz

StageBio Acquires TPL Path Labs to Expand its Footprints Globally

Published: Oct 20, 2020 | Tags: Acquisition, Expands, Global Presence, StageBio, TPL Path Labs

Endo to Acquire BioSpecifics for ~ $540M

Published: Oct 19, 2020 | Tags: $ 540 M, Acquire, BioSpecifics, Endo

Bayer and 111 Collaborate to Explore the Vast Blue Ocean of Online Healthcare in China

Published: Oct 19, 2020 | Tags: 111, Bayer, China, Extend, Inc., Vast Blue Ocean of Online Healthcare

Roche Collaborates with Genesis Therapeutics for AI-Driven Drug Discovery

Published: Oct 19, 2020 | Tags: AI-Driven, Collaborates, Drug Discovery, Genesis Therapeutics, Roche

AstraZeneca’s Tagrisso (osimertinib) Receives the US FDA’s Priority Review for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer

Published: Oct 20, 2020 | Tags: Adjuvant, AstraZeneca, Cancer, Early, EGFR, Lung, Mutated, osimertinib, reports, results, Stage, Tagrisso, Treatment, US

AbbVie Submits Regulatory Applications to the US FDA and EMA for Rinvoq (upadacitinib) to Treat Atopic Dermatitis

Published: Oct 19, 2020 | Tags: AbbVie, Atopic Dermatitis, P-lll Study, Rinvoq, Submit Regulatory Application, Upadacitinib, US FDA and EMA

ImmunoGen Signs an Agreement with Huadong to Develop & Commercialize Mirvetuximab Soravtansine in Greater China

Published: Oct 19, 2020 | Tags: Collaboration, Commercialize, Develop, Greater China, Huadong, ImmunoGen, Mirvetuximab Soravtansine, Signs

Henlius Signs a License Agreement with Essex to Co-develop HLX04 (biosimilar, bevacizumab) for Ophthalmic Diseases

Published: Oct 18, 2020 | Tags: $43M, Agreement, bevacizumab, Develop, Diseases, Essex, Henlius, Jointly, License, Ophthalmic, Signs, Treat

Sanofi’s Sarclisa (isatuximab) Receives NICE Recommendation for Patients with Multiple Myeloma

Published: Oct 18, 2020 | Tags: FAD, Isatuximab, Multiple Myeloma, NICE, patients, receives, Recommendation, Sanofi, Sarclisa

Janssen’s Tremfya (guselkumab) Receives CHMP’s Positive Opinion for Approval to Treat Active Psoriatic Arthritis (PsA)

Published: Oct 18, 2020 | Tags: approval, CHMP Positive Opinion, guselkumab, Janseen, PsA, receives, Tremfya

AstraZeneca’s Trixeo Aerosphere Receives CHMP’s Recommendation for Approval to Treat COPD

Published: Oct 19, 2020 | Tags: approval, AstraZeneca, CHMP, COPD, EU, Maintenance, Recommendation, Treatment, Trixeo, Aerosphere

AbbVie and Roche’s Venclexta (venetoclax) Receive the US FDA’s Approval for Acute Myeloid Leukemia

Published: Oct 19, 2020 | Tags: AbbVie, Acute Myeloid Leukemia, receives, US FDA, Approval, Venclexta, venetoclax

Novartis’ Leqvio (inclisiran) Receives CHMP’s Positive Opinion for Approval to Treat Hypercholesterolemia

Published: Oct 17, 2020 | Tags: (inclisiran), approval, CHMP, Hypercholesterolemia, Leqvio, Novartis, Positive, Opinion, receives, Treat

Related Post: PharmaShots Weekly Snapshot (Oct 12-16, 2020)

The post PharmaShots Weekly Snapshot (Oct 19 – 23, 2020) first appeared on PharmaShots.

Novartis launches digital health hub in Canada

Novartis is opening a new digital health innovation hub in Canada to help develop “scalable, digital solutions” for patients and healthcare providers.

The Canadian Biome Digital Innovation Hub will be based in Montreal at the artificial intelligence research institute, Mila. The institute formed a strategic alliance with Novartis in 2019.

Canada is the latest country to join a global network of hubs opened by Novartis. The company has established centres in the US, UK, France and India.

The Canadian Biome has already struck a partnership with Canadian virtual care specialist company Insig Health to launch a digital health accelerator. Other companies joining the Biome network include ConversationHEALTH, which develops AI healthcare chatbots, and Amblyotech, a digital therapeutics company for treating amblyopia.

Novartis announced the news at the virtual XEFFERVESCENCE Digital and AI in the Healthcare Industry event, attended by government officials and members of the healthcare industry.

Canada is investing to position itself as a world-leading destination for AI innovation. In 2017, it was the first country to announce a national AI strategy, and the government has invested $125M in a five-year Pan-Canadian Artificial Intelligence Strategy.

The goals of the strategy include increasing the number of AI researchers and graduates, partnering with AI institutes and developing global thought leadership on the economic, ethical, policy and legal implications of advances in AI.

Christian Macher, country president at Novartis Pharmaceuticals Canada said Novartis was calling on start-ups to join the Biome.

“Our goal with the Biome is to become the leading health tech pharma company in Canada,” he said, “working in collaboration with health tech pioneers who will become our partners in creating better healthcare solutions that can help enhance and accelerate the patient journey from diagnosis through treatment.”

The post Novartis launches digital health hub in Canada appeared first on .

Top 20 Immunology Companies Based 2019 Immunology Segment Revenue

Immunology is an important branch of science which deals with the study of the immune system. The immune system is a highly regulated and balanced system and when the balance is disturbed, the disease can result. A lot of this work has importance in the development of new therapies and treatments that can handle or heal the condition by modifying the way the immune system is working or, in the case of vaccines, instructing the immune system and enhancing the immune reaction to specific pathogens. In the top 20 ledgers, AbbVie again ensured the top position with total revenue of $19.57B with its blockbuster drug, Humira (adalimumab) from its immunological segment. Our team at PharmaShots has compiled a list of the top 20 immunology companies based on their 2019 immunology revenue

Immunology Segment Revenue: $0.01B

Founded Year: 1979

Market Cap: ~ $0.49B

Total Employees: ~178

Headquarter: New Jersey, United States

Stock Exchange: NASDAQ

Antares Pharma is an American pharmaceutical company focus on developing and commercializing therapies for rheumatology, urology, endocrinology, and neurology. Antares has reported a total sale of $0.01B from its immunology segment in 2019

Immunology Segment Revenue: $0.24B

Founded Year: 2008

Market Cap: ~$15.70B

Total Employees: ~1,200

Headquarter: Dublin, Ireland

Stock Exchange: NASDAQ

Horizon Therapeutics is an Ireland based biopharmaceutical company focused on developing and commercializing therapies for the treatment of gout, rheumatoid arthritis, and rare diseases. Horizon has generated the sale of $0.24B from its four approved immunology products including Tepezza, Rayos, Duexis and Vimovo. Horizon’s Tepezza was selected for “2020 R&D World R&D 100 Award”

Immunology Segment Revenue: $0.49B

Founded Year: 1993

Market Cap: ~$2.57B

Total Employees: ~5,047

Headquarter: Shenyang, China

Stock Exchange: HKD

3SBio is a fully integrated Chinese biotechnology company with market-leading biopharmaceutical franchises in oncology, auto-immune diseases, nephrology, metabolic diseases, and dermatology. There are three approved drugs in its immunology portfolio including Yisaipu, Tpiao and Xenopax. 3SBio’s Tpiao used to treat chemotherapy-induced thrombopenia (approved in 2005) and immune thrombocytopenia has generated global sales of $0.33B in 2019.

Immunology Segment Revenue: $0.73B

Founded Year: 1978

Market Cap: ~$42.57B

Total Employees: ~7,400

Headquarter: Massachusetts, United States

Stock Exchange: NASDAQ

Biogen is a global biopharma company focused on neurology, hematologic, and autoimmune diseases. Biogen has a total of six products in its immunology segment with four approved drugs including Tysabri, IMRALDI, FLIXABI, BENEPALI. Biogen’s lead drug Tysabri recorded a revenue of $1.89B. Biogen revealed the positive result of BIIB059 in the Phase 2 LILAC study for cutaneous lupus erythematosus and systemic lupus erythematosus.

Immunology Segment Revenue: $0.81B

Founded Year: 2000

Market Cap: ~$88.14

Total Employees: ~99,000

Headquarter: Brentford, United Kingdom

Stock Exchange: LON

GlaxoSmithKline (GSK) is a global healthcare company serving the world with drugs, vaccines & consumer healthcare products. With only approved products, Benlysta, GSK has generated a revenue of $0.81B in 2019. In Jul 2019, GSK initiated the phase 3 study of otilimab for rheumatoid arthritis. In Sep’19, EMA granted a positive CHMP opinion for intravenous Benlysta in children with lupus and was approved in Oct 2019.

Immunology Segment Revenue: $1.11B

Founded Year: 2007

Market Cap: ~$34.6B

Total Employees: ~7,228

Headquarter: Osaka, Japan

Stock Exchange: TYO

Mitsubishi Tanabe is a Japanese pharma company focused on autoimmune diseases, diabetes and kidney diseases, neurological disorders, and vaccines. Mitsubishi has reported a total sale of $1.11B from its immunology segment in 2019.

Immunology Segment Revenue: $1.24B

Founded Year: 1891

Market Cap: ~$197.46B

Total Employees: ~71,000

Headquarter: New Jersey, United States

Stock Exchange: NYSE

Merck & Co. is a global health care company delivering innovative health care products with its Prescription medicines, Oncology drugs, Vaccines, Biologic therapies, and Animal Health care products. Merck has recorded the sale of $1.24B in 2019 from its five approved drugs in its immunology portfolio including Simponi, Remicade, Renflexis, Brenzys, Hadlima. Simponi and Remicade was co-commercialized by Merck and Johnson & Johnson and Simponi recorded the revenue of $0.83B in 2019.

Immunology Segment Revenue: $1.68B

Founded Year: 1991

Market Cap: ~$19.38B

Total Employees: ~1,300

Headquarter: Delaware, United States

Stock Exchange: NASDAQ

Incyte Corp is a global biopharmaceutical firm focused on developing therapies in two categories Oncology and Inflammation & Autoimmune. Incyte has generated a revenue of $1.68B from its immunological segment. In Jan’19, Incyte reports results of Itacitinib in GRAVITAS-301 P-III study for patients with treatment-naive acute graft-versus-host disease.

Immunology Segment Revenue: $1.79B

Founded Year: 2005

Market Cap: ~ $26.49B

Total Employees: ~15,883

Headquarter: Tokyo, Japan

Stock Exchange: TYO

Astellas Pharma is a Japanese multinational pharmaceutical company focused on the therapeutic fields of urology, immunology including transplantation and infectious diseases, oncology, neuroscience and DM complications, and metabolic diseases. Astellas has four drugs in its immunology portfolio including two approved drugs Smyraf And Prograf and has recorded the sale of $1.79B in 2019. In Jul’19, Astellas Pharma launched Smyraf 50 mg and 100 mg tablets for rheumatoid arthritis.

Immunology Segment Revenue: $1.79B

Founded Year: 1901

Market Cap: ~$135.16B

Total Employees: ~33,625

Headquarter: Indiana, United States

Stock Exchange: NYSE

Eli Lilly and Company is a global pharmaceutical firm focused on delivering therapies in two divisions Human Pharmaceutical Products and Animal Health products. The pharmaceutical portfolio offers products for Cardiovascular, Endocrinology, Immunology, Neuroscience, and Oncology. Eli Lilly has two approved drugs including Taltz and Olumiant. Lilly’s Taltz, an approved drug for plaque psoriasis or psoriatic arthritis has generated a revenue of $1.6B in 2019. In Apr’19, Eli Lilly signs research and licensing agreement with avidity biosciences to develop therapies in immunology.

Immunology Segment Revenue: $1.92B

Founded Year: 1928

Market Cap: ~$20.49

Total Employees: ~7,600

Headquarter: Brussels, Belgium

Stock Exchange: EBR

UCB is a global biopharmaceutical company focused on neurology, inflammatory, gastrointestinal and autoimmune disorders. UCB has recorded the sale of $1.92B in 2019 from its immunology segment with its only approved drug, Cimzia indicated for psoriatic arthritis (PsA). In Jul’19, Cimzia was approved by China’s NMPA.

Immunology Segment Revenue: $2.53B

Founded Year: 1973

Market Cap: ~$122.35B

Total Employees: ~100,000

Headquarter: Paris, France

Stock Exchange: EPA

Sanofi is a global healthcare leader in vaccines providing healthcare solutions in 170+ countries around the world. Sanofi is ranked third in the global market and first in EU and Latin America. Sanofi has four drugs in its immunology portfolio including one approved drug Kevzara, developed in partnership with Regeneron. In Dec’19, Sanofi presented the positive result from its pivoted phase 3 study of sutimlimab for cold agglutinin disease. Additionally, Sanofi restructured its agreement with Regeneron to obtain worldwide rights for Kevzara.

Immunology Segment Revenue: $2.97B

Founded Year: 1887

Market Cap: ~$135.30B

Total Employees: ~30,000

Headquarter: New York, United States

Stock Exchange: NYSE

Bristol-Myers Squibb is an American pharmaceutical company focused on Oncology, Cardiovascular, Immuno-Science, and Fibrosis. BMS has two approved drugs Orencia and Nulojix. BMS’ Orencia is a protein indicated to treat adult rheumatoid arthritis, juvenile idiopathic arthritis, and adult psoriatic arthritis has generated the highest revenue of $2.97B in 2019. The acquisition of Celgene in 2019, has boosted up BMS’ Immunology pipeline.

Immunology Segment Revenue: $3.66B

Founded Year: 1925

Market Cap: ~$52.60B

Total Employees: ~49,578

Headquarter: Osaka, Japan

Stock Exchange: TYO

Takeda is a global biopharma company focused on Oncology, Gastroenterology (GI), Neuroscience, Immunology, and Rare Diseases. With three approved drugs including Immunoglobulin, Albumin, and Entyvio, Takeda has generated a $3.66B sale in 2019. In Apr’19, EMA accepted the application for a subcutaneous formulation of Entyvio in Crohn’s disease, and in Oct 2019, Takeda acquired CNP-101 from COUR Pharmaceuticals. In Feb’20, Takeda acquired PvP Biologics to strengthen its immunology pipeline. Additionally, Takeda got approval for Entyvio from China’s NMPA for Crohn’s disease in Mar 2020.

Immunology Segment Revenue: $4.22B

Founded Year: 1996

Market Cap: ~$205.93B

Total Employees: ~109,000

Headquarter: Basel, Switzerland

Stock Exchange: SIX Swiss Exchange, NYSE

Novartis is a multinational group of companies specializing in research, development, manufacturing, and marketing with a broad range of healthcare solutions including generic and ophthalmic therapies. The company is focused on Immunology, Hepatology, Dermatology, Oncology, Neurology, and Ophthalmology. Novartis has the uppermost number of immunology drugs with eight approved products including ACZ885/Ilaris, AIN457/Cosentyx, Myfortic (Renal transplant), Neoral, Simulect, and Zortress. Novartis’ Cosentyx (secukinumab) used to treat Psoriasis, ankylosing spondylitis and psoriatic arthritis have generated global sales of $3.55B in 2019. In Apr’19 Novartis acquired IFM Tre to enhance its immunologic portfolio with its NLRP3 inhibitors for $1.5B.

Immunology Segment Revenue: $4.73B

Founded Year: 1849

Market Cap: ~$206.05B

Total Employees: ~83,000

Headquarter: New York, United States

Stock Exchange: NYSE

Pfizer is a research-based, global biopharmaceutical company having a vast portfolio including Oncology, Medicines, vaccines, and other health care products for the prevention & treatment of untreated diseases. With 3 approved drugs including Xeljanz, Enbrel (outside the US and Canada), and Inflectra (Biosimilar), Pfizer has generated $4.73B sale from its immunology portfolio indicated for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, Behcet’s disease, and ulcerative colitis. Pfizer’s Xeljanz has generated revenue of $2.24B in 2019. In Jan’2019, CytoReason signed a research partnership with Pfizer to develop drugs using CytoReason’s cell-centered models of the immune system.

Immunology Segment Revenue: $5.39B

Founded Year: 1980

Market Cap: ~$134.11B

Total Employees: ~23,400

Headquarter: California, United States

Stock Exchange: NASDAQ

Amgen is one of the leading biotechnology company developing novel therapies focused on cardiology, oncology, neurology, nephrology, and inflammatory diseases. Amgen has generated a total sale of $5.39B in 2019 with its drugs Otezla, Avsola, Enbrel, Nplate, and Prolia. Amgen’s Otezla used to treat certain types of psoriasis and psoriatic arthritis has generated sales of $1.6B.

Immunology Segment Revenue: $8.79B

Founded Year: 1896

Market Cap: ~ $281.59B

Total Employees: ~98,000

Headquarter: Basel, Switzerland

Stock Exchange: SWX

Roche Holding AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. The immunology department focus on rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, and giant cell arteritis including severe persistent allergic asthma (AA), chronic idiopathic urticaria (CIU), and idiopathic pulmonary fibrosis (IPF) with 3 approved drugs including Actemra, CellCept and Mabthera and has generated the sale of $8.97B in 2019. In Dec’2019, Roche signed an exclusive global option and license agreement with Rheos Medicines to develop and commercialize therapies for immune metabolism.

Immunology Segment Revenue: $13.95B

Founded Year: 1887

Market Cap: ~$378.94B

Total Employees: ~132,100

Headquarter: New Jersey, United States

Stock Exchange: NYSE

Johnson & Johnson (J&J) is an American multinational healthcare company focused on the development and commercialization of pharmaceutical, medical device, and consumer packaged products. The pharmaceutical portfolio offers products for Cardiovascular, Endocrinology, Immunology, Neuroscience, and Oncology. J&J has generated $13.95B from its Immunology portfolio with 5 approved products including Remicade, Simponi, Stelara, Tremfya, Simponi Aria. Remicade was jointly marketed by J&J and Merck and has generated a revenue of $4.38B in 2019. In Nov 2019, J&J’s Tremfya meets the primary endpoint in the phase 3 study for Psoriatic Arthritis. Additionally, J&J submit two applications with the USFDA for Polyarticular Juvenile Idiopathic Arthritis and Juvenile Psoriatic Arthritis. FDA approved Tremfya for Psoriatic Arthritis and Simponi Aria for polyarticular juvenile idiopathic arthritis and active psoriatic arthritis for patients 2 years of age and older in Jul 2020.

Immunology Segment Revenue: $19.57B

Founded Year: 2012

Market Cap: ~$146.29B

Total Employees: ~30,000

Headquarter: Illinois, United States

Stock Exchange: NYSE

AbbVie is a global, research and development-based biopharmaceutical company focused on developing innovative advanced therapies. The company is focused on developing products in immunology, oncology, virology, and neuroscience, dermatology. AbbVie has generated the sale of $19.57B in 2019 from its immunological segment with 3 approved drugs including RINVOQ, SKYRIZI, HUMIRA. AbbVie’s blockbuster drug HUMIRA recorded a revenue of $19.16B. In Apr’2019, AbbVie received EMA approval of SKYRIZI for Plaque Psoriasis. Its RA drug RINVOQ received FDA approval in Aug 2019 and EMA approval in Dec 2019. Additionally, RINVOQ achieved positive results in primary and key secondary endpoints for Psoriatic Arthritis and subsequently submitted the regulatory applications with the FDA and EMA.

Related Post: Top 20 Immunology Companies Based on 2018 Immunology Segment Revenue

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The post Top 20 Immunology Companies Based 2019 Immunology Segment Revenue first appeared on PharmaShots.

Novartis’s Branaplam (LMI070) Receives the US FDA’s Orphan Drug Designation for Huntington’s Disease

Shots:

  • The US FDA has granted ODD for branaplam in HD. In preclinical trials, branaplam demonstrated a reduction in levels of the mutant huntingtin protein. Additionally, the therapy showed a reduction in huntingtin mRNA in SMA patients
  • Novartis expects to initiate the P-IIb study for branaplam in HD patients in 2021
  • Branaplam (qw, PO) is an RNA splicing modulator, currently under investigation for the treatment of SMA

Click here ­to­ read full press release/ article | Ref: Novartis | Image: Pfarma

The post Novartis’s Branaplam (LMI070) Receives the US FDA’s Orphan Drug Designation for Huntington’s Disease first appeared on PharmaShots.

Novartis’ big bet on inclisiran nears fruition, as CHMP backs drug

Novartis’ near-$10 billion takeover of The Medicines Company last year was focused mainly on one asset – cholesterol-lowering drug inclisiran – and the Swiss pharma is now a step closer to getting a return on its investment.

Inclisiran – now give the trade name Leqvio – has been recommended for approval by the CHMP as a treatment for hypercholesterolaemia or mixed dyslipidaemia, two common forms of elevated cholesterol linked to increased risk of cardiovascular disease.

If approved, inclisiran would become the first and only gene-silencing drug to reduce low-density lipoprotein cholesterol (LDL-C) in these patients.

The drug inhibits PCSK9 – the same target as Amgen’s Repatha (evolocumab) and Sanofi/Regeneron’s Repatha (alirocumab) – but is dosed only twice a year rather than every month.

Novartis is hoping that with Leqvio it will make a mark where the antibody drugs have largely failed, with sales of Repatha and Praluent still failing to gather much momentum despite being on the market for more than five years, after pushback from payers that wasn’t overcome by substantial price cuts.

The big question for Novartis is whether Leqvio’s more convenient dosing will be enough for it to overtake its antibody-based rivals, given that they seem to be fairly equivalent when it comes to lowering LDL-C.

Novartis’ drug is also playing catch-up with its rivals on data from trials that show the reduction in LDL-C is matched by an improvement in cardiovascular outcomes.

Both Repatha and Praluent have that in hand, but Novartis will have to wait for the results of the ORION-4 study – due in 2024 – before it has a chance of matching the labels of Amgen and Sanofi/Regeneron’s drugs.

That said, Novartis is no stranger to building a slow-starting cardiovascular drug into a blockbuster franchise. It’s a trick it carried out with Entresto (sacubitril/valsartan) – a drug for heart failure – that after a sluggish roll-out is now bringing in sales at a rate of more than $2 billion a year.

That also means the Swiss drugmaker will also be able to push Leqvio through the sales channels that have made Entresto a blockbuster, but it will need to make swift progress if it is to get a reasonable return on the investment in MedCo.

Evercore ISI analyst Umer Raffat has previously said he thinks that will come if Leqvio hits $2 billion in peak annual sales.

Novartis already has some deals in place that could help it reach that target, including an access pact with NHS England aimed at accelerating access to Leqvio after EMA approval. Billed by Novartis as a “world-first”, the deal would see the drug made available to people with atherosclerotic cardiovascular disease.

Earlier this year analysts at Clarivate said they expect Leqvio to reach $1.16 billion in sales by 2024 as a treatment for elevated blood cholesterol among the 80% or so of patients who don’t respond to older statin drugs.

The CHMP sets up a likely EMA approval for Leqvio before the end of the year, and Novartis is also expecting to hear back from the FDA on the drug in the same timeframe.

The post Novartis’ big bet on inclisiran nears fruition, as CHMP backs drug appeared first on .

Novartis’ Leqvio (inclisiran) Receives CHMP’s Positive Opinion for Approval to Treat Hypercholesterolemia

Shots:

  • The CHMP’s positive opinion is based on ORION program including P-III studies assessing Leqvio in 3,600+ patients on a maximally tolerated statin dose. Inclisiran demonstrated effective and sustained LDL-C reduction of up to 52% with 2doses/yr, after an initial dose and one @3mos., in adults with ASCVD, ASCVD risk equivalent or HeFH6
  • 80% of high-risk patients do not reach guideline-recommended LDC-L, targets despite the widespread use of statins. Reduction in LDL-C was achieved through 17mos. with a safety and tolerability profile like PBO
  • Additional post hoc analysis demonstrated 88% of them reached guideline-recommended targets at any timepoint during the study. Additionally, the therapy is also under review by the US FDA and other health authorities for primary hyperlipidemia in adults who have elevated LDL-C while being on a maximally tolerated dose of statin therapy

Click here ­to­ read full press release/ article | Ref: Novartis | Image: Easy Health Options

The post Novartis’ Leqvio (inclisiran) Receives CHMP’s Positive Opinion for Approval to Treat Hypercholesterolemia first appeared on PharmaShots.

PharmaShots Weekly Snapshot (Oct 12-16, 2020)

Novartis’s Luxturna (voretigene neparvovec) Receives Health Canada Approval as the First Gene Replacement Therapy for Inherited Retinal Disease

Published: Oct 15, 2020 | Tags: approval, Canada, health, Inherited Retinal Disease, Luxturna, Novartis, receives, voretigene neparvovec

Galapagos & Servier’s GLPG1972/S201086 Fails to Meet its Primary Endpoint in P-II ROCCELLA Study for Knee Osteoarthritis

Published: Oct 15, 2020 | Tags: Clinical, Trial, Galapagos, GLPG1972/S201086, Knee Osteoarthritis, Patients, P-II, Report, results, ROCCELLA, Servier

Sanofi and Translate Bio to Advance MRT5500 into Clinical Study Against COVID-19

Published: Oct 15, 2020 | Tags: advance, Against, Clinical, Study, COVID-19, MRT5500, Sanofi, Translate, Bio

Chugai Reports NDA Submission of Risdiplam to the MHLW as the First Oral Drug for SMA in Japan

Published: Oct 15, 2020 | Tags: Chugai, Drug, First, Japan, MHLW, NDA, Oral, Report, Risdiplam, Spinal Muscular Atrophy

Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval for Relapsed or Refractory Classical Hodgkin Lymphoma

Published: Oct 15, 2020 | Tags: Adult, approval, KEYTRUDA, Merck, patients, pembrolizumab, receives, Relapsed Refractory cHL, US, FDA

Eli Lily to Acquire Disarm Therapeutics for ~$1.36B

Published: Oct 15, 2020 | Tags: ~$1.36B, Acquire, Disarm, Therapeutics, Eli Lily

Eli Lilly Pauses Enrollment in ACTIV-3 Clinical Trial Due to Safety Concerns

Published: Oct 14, 2020 | Tags: ACTIV-3, Clinical, Decision, Due, Eli Lilly, Enrollment, NIAID, Pause, Trial

Sorrento to Initiate P-II Study of STI-5656 (abivertinib maleate) for COVID-19 in Brazil

Published: Oct 14, 2020 | Tags: Abivertinib Maleate, ANVISA, approval, COVID-19, Mild, P-II, patients, Proceed, receives, Severe, Sorrento, STI-5656, Trial

Bayer Report Results of Aliqopa (copanlisib) + Rituximab in P-III CHRONOS-3 Study for Relapsed Indolent Non-Hodgkin’s Lymphoma

Published: Oct 14, 2020 | Tags: 1EP, Aliqopa, Bayer, copanlisib, Meets, patients, reports, results, Rituximab

Takeda Collaborates with Accenture and AWS to Transform into a Cloud-Based Company

Published: Oct 13, 2020 | Tags: Accenture, AWS, Cloud-Based Company, Collaborates, Takeda, Transform

Regeneron’s Inmazeb (atoltivimab, maftivimab, and odesivimab) Receives the US FDA’s Approval as the First Treatment for Ebola

Published: Oct 15, 2020 | Tags: approval, atoltivimab, Ebolavirus, First, Inmazeb, maftivimab, odesivimab, receives, Regeneron, Treatment, US, FDA

Roche Signs a License Agreement with Dyno to Develop AVV Gene Therapy for ~$1.8B

Published: Oct 14, 2020 | Tags: ~$1.8B, AVV, Gene, Therapy, Develop, Dyno, License, Agreement, Roche, Signs

Boehringer Ingelheim Presents Results of Gilotrif (afatinib) for NSCLC at IASLC NACLC 2020

Published: Oct 14, 2020 | Tags: 2020, Boehringer Ingelheim, Gilotrif, IASLC, NACLC, Report, Result

Moderna Initiates Rolling Submission to Health Canada for mRNA-1273 Against COVID-19  

Published: Oct 14, 2020 | Tags: COVID-19, Health Canada, Moderna, mRNA Vaccine, mRNA-1273, Rolling Submission

Prestige’s PBP1510 Receives EMA’s Positive Opinion on Orphan Designation for Pancreatic Cancer

Published: Oct 14, 2020 | Tags: Designation, EMA, Opinion, Orphan, Pancreatic cancer, PBP1510, Positive, Prestige, receives

Celltrion Launch P-III Post-Exposure Prophylaxis Clinical Trial of CT-P59 for COVID-19

Published: Oct 14, 2020 | Tags: Anti, Candidate, Celltrion, Clinical Trial, COVID-19, CT-P59, Launch, mAb, P-III, Treatment

Linnaeus Reports First Patients Dosing with LNS8801 + Keytruda (pembrolizumab) in P-I/II Study for Advanced Cancer

Published: Oct 14,2020 | Tags: Advanced Cancer, First Patients Dosing, KEYTRUDA, Linnaeus, LNS8801, pembrolizumab, reports

J&J Pauses Dosing in COVID-19 Vaccine Studies Due to Unexplained Illness

Published: Oct 14, 2020 | Tags: COVID-19, Dosing, J&J, Pauses, Unexplained Illness, Vaccine, Studies

Roche to Launch Elecsys SARS-CoV-2 Antigen Test for Suspected COVID-19 Patients

Published: Oct 13, 2020 | Tags: Antigen, COVID-19, Laboratory, Launch, patients, Roche, SARS-CoV-2, Suspected, Test

Sanofi Reports Results of Dupixent (dupilumab) in P-III LIBERTY ASTHMA VOYAGE Study in Children with Asthma

Published: Oct 13, 2020 | Tags: Asthma, attacks, Biologic, Children, children’s, Demonstrate, dupilumab, Dupixent, Function, Improvement, Lung, P-III Trial, Reduced, reports, results, Sanofi, Severe

Gilead and Galapagos Report Results of Filgotinib in P-llb/lll SELECTION Study for Ulcerative Colitis

Published: Oct 13, 2020 | Tags: Filgotinib, Galapagos, Gilead, P-2B/3, reports, results, SELECTION Study, Ulcerative Colitis (UC)

Lilly Reports Results of Mirikizumab in P-ll SERENITY Study for Crohn’s Disease

Published: Oct 13, 2020 | Tags: Crohn Disease, Improvement and Reduction of Intestinal Inflammation, Lilly, Mirikizumab, P-ll, reports, results, SERENITY Study

Takeda Reports Results of Entyvio (vedolizumab) in Interim Analysis from VISIBLE OLE Study for Moderately to Severely Active Ulcerative Colitis

Published: Oct 13, 2020 | Tags: Active, During, Entyvio, Long-Term, Maintenance, Moderately, reports, results, Severely, Takeda, therapy, Vedolizumab

Abbott’s AdviseDx SARS-CoV-2 IgM Test Receives the US FDA’s EUA for COVID-19

Published: Oct 13, 2020 | Tags: Abbott, antibody, Authorization, Blood, Test, COVID-19, Emergency, IgM, New, receives, Test, U.S.FDA, Use

Innovent and Lilly’s Halpryza (biosimilar, rituximab) Receive NMPA’s Approval in China

Published: Oct 12, 2020 | Tags: Autoimmune Disease, Halpryza, Innovent, Lilly, NMPA Granted Marketing Approval, Rituximab

Janssen Reports Five-Year Data of Stelara (ustekinumab) in P-lll LTE Study for Severe Crohn’s Disease

Published: Oct 12, 2020 | Tags: Five-Year, Janssen Pharmaceutical, LTE Study, P-lll, Report, results, Severe Crohn’s Disease, Stelara, ustekinumab

AstraZeneca Advances its AZD7442 in Two P-III Clinical Studies for COVID-19

Published: Oct 12,2020 | Tags: Acting, antibody, AstraZeneca, AZD7442, COVID-19, Long, P-III, Test, Treatment, Trials

Janssen Reports Results of Tremfya (guselkumab) in Interim Analysis of P-II GALAXI 1 Study for Moderately to Severely Active Crohn’s Disease

Published: Oct 12,2020 | Tags: Active Crohn’s Disease, guselkumab, Interim, Janssen, P-II, patients, reports, Result, study, Tremfya

Pfizer’s Ibrance (palbociclib) Fails to Meet its Primary Endpoint in P-lll PENELOPE-B Study for Early Breast Cancer

Published: Oct 12,2020 | Tags: Breast Cancer, German Breast Group, Ibrance, P-lll, Palbociclib, PENELOPE-B Study, Pfizer Inc., Report, results

Innovent and Lilly’s Halpryza (biosimilar, rituximab) Receive NMPA’s Approval in China

Published: Oct 10,2020 | Tags: Autoimmune Disease, Halpryza, Innovent, Lilly, NMPA, Granted, Marketing Approval, Rituximab

Related Post: PharmaShots Weekly Snapshot (Oct 5-9, 2020)

The post PharmaShots Weekly Snapshot (Oct 12-16, 2020) first appeared on PharmaShots.

Novartis’s Luxturna (voretigene neparvovec) Receives Health Canada Approval as the First Gene Replacement Therapy for Inherited Retinal Disease

Shots:

  • Health Canada has approved Luxturna (voretigene neparvovec) as a one-time gene therapy for the treatment of adult & pediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells
  • Luxturna is designed to provide functioning copies of the RPE65 gene to act in place of mutated RPE65 genes. The functioning genes work to restore vision and improve sight, giving patients the potential for greater independence
  • Novartis has entered a partnership with Blueprint Genetics to facilitate the genetic testing where appropriate to validate the diagnosis

Click here ­to­ read full press release/ article | Ref: Newswire Canada | Image: Technologies

The post Novartis’s Luxturna (voretigene neparvovec) Receives Health Canada Approval as the First Gene Replacement Therapy for Inherited Retinal Disease first appeared on PharmaShots.

NICE changes its mind on Novartis’ progressive MS drug Mayzent

UK cost-effectiveness agency NICE has backed Novartis’ Mayzent for secondary progressive multiple sclerosis (SPMS), after turning it down earlier this year in draft guidance.

The change of heart means Mayzent (siponimod) becomes the first oral disease-modifying therapy to be recommended for NHS use in SPMS patients with active disease, defined as relapses or evidence of active inflammation of neurons on imaging.

Secondary progressive disease can occur after the relapsing/remitting stage of the disease, where patients experience fewer or no relapses but find their disability is increasing.

In June, NICE said it wasn’t able to support the use of Mayzent because there was limited clinical evidence for its benefits in SPMS, and it was not persuaded by the cost-effectiveness modelling submitted by Novartis.

Now, a consultation period and a new commercial agreement with Novartis to supply the drug at a discount on its £1,643.72 monthly list price means that around 38,000 people with SPMS across the UK could get access to the drug – which the MS Society charity says is “a huge step forward” for patients.

The NICE judgment for England and Wales follows a positive verdict from the Scottish Medicines Consortium (SMC) a few days ago. In Northern Ireland, the Department of Health reviews NICE guidance before deciding on use of a new drug.

Mayzent provides a treatment option to many people living with MS where once there was none, according to the MS Society, which said that people transitioning from relapsing/remitting MS to SPMS “have faced an immensely difficult challenge – being forced to go from having a range of treatments available to them, to severely limited choices.”

At the same time, for some people living with the secondary progressive form of the disease who are able to take beta interferons – currently given by injection – Mayzent provides a less intrusive choice, according to the charity.

Historically, the diagnosis of SPMS with active disease has often been delayed or avoided due to uncertainty around disease progression, as well as the lack of any effective treatment, says Novartis.

“We are working closely with the NHS to ensure eligible patients can start benefiting from siponimod as soon as possible,” said Chinmay Bhatt, managing director for Novartis Pharma UK, Ireland & Nordics.

Mayzent has the same mechanism of action as Novartis’ older drug Gilenya (fingolimod), which is approved for RRMS but not SPMS.

The drug was approved in Europe in January based on the 779-patient phase 3 EXPAND trial which showed that it significantly reduced the risk of disease progression, including physical disability and cognitive decline.

In a subgroup of Mayzent-treated patients with active disease, the data showed that the risk of three-month and six-month confirmed disability progression was significantly reduced, by 31% and 37% respectively, compared with placebo.

“By slowing down disability progression and improving cognition, siponimod has the potential to allow people to carry on working, remain independent and stay connected with family and friends,”  commented David Martin, chief executive of the MS Trust patient organisation.

“More broadly, we hope that the availability of this new treatment will lead to a greater focus on services for progressive MS which would benefit a much wider group of people,” he added.

The post NICE changes its mind on Novartis’ progressive MS drug Mayzent appeared first on .

Merck Signs an Out-Licensing Agreement with Novartis for M6495 (Anti-ADAMTS5 Nanobody) for Osteoarthritis

Shots:

  • Merck to receive an € 50M upfront payment and € 400M development and commercial milestones and royalties on future net sales. Novartis will hold full responsibility for the development and commercialization of the M6495 program
  • Two P-I studies were completed with M6495 where NCT03224702 in healthy volunteers demonstrated safety and tolerability and reduction of ARGS levels at single doses (n=54) and NCT03583346 targets inhibition of ARGS with dosing every other week in OA patients    
  • M6495 is being developed to be self-administered via SC injections to maintain structural integrity of knee joint and reduce pain. M6495 was originally jointly developed by Merck and Ablynx as part of a joint discovery and development agreement in 2011

Click here to­ read full press release/ article | Ref: Merck | Image: Stem Cells Transplant Institute

The post Merck Signs an Out-Licensing Agreement with Novartis for M6495 (Anti-ADAMTS5 Nanobody) for Osteoarthritis first appeared on PharmaShots.

Novartis Reports Results of Beovu (brolucizumab) in Two New Post-Hoc Analyses of P-III HAWK and HARRIER Studies for Wet AMD

Shots:

  • The P-III HAWK (6/3mg) & HARRIER (6mg) study assessing Beovu [q12w/q8w with the majority on q12w following the loading phase) vs aflibercept (2mg) in 1,800 patients with wet AMD across 400 centers
  • Results: first analysis ewer patients had early persistent fluid (12.5% vs 20.4%), defined as the presence of intra-retinal fluid or subretinal fluid through @12wks. treatment, patients gain greater BVCA (6.4 vs.3.7), CST control (80% vs 69%) respectively, presented at EURETINA
  •  Beovu is the first advanced humanized scFv, approved for clinical use in 40+ countries, including in the US, EU, UK, Japan, Canada, and Australia

Click here ­to­ read full press release/ article | Ref: Novartis | Image: Novartis

The post Novartis Reports Results of Beovu (brolucizumab) in Two New Post-Hoc Analyses of P-III HAWK and HARRIER Studies for Wet AMD first appeared on PharmaShots.

Novartis Reports Results of Zolgensma in P-III STR1VE-EU Study for SMA Type 1

Shots:  

  • The P-III STR1VE-EU study involves assessing Zolgensma (IV) in patients with SMA Type 1 aged <6mos. at the time of gene therapy, with 1 or 2 copies of the SMN2 backup gene and have bi-allelic SMN1 gene deletion or point mutations
  • Results: 65.6% achieved motor milestones not observed in the natural history of SMA Type 1, 66.7% were free of feeding support, 93.9% are able to swallow thin liquids, 30.3% required feeding support, 27.3% required ventilatory support; 97% patients in ITT population survived event-free, including 93.8% & 56.3% who could have reached 10.5mos. & 13.6 mos. of age respectively
  • New interim P-III STR1VE-EU data presented at WMS support the clinical evidence demonstrating a consistent, transformative benefit across Zolgensma clinical trials for the treatment of patients with SMA

Click here ­to­ read full press release/ article | Ref: Novartis | Image: Mint

Related News: Novartis’ Zolgensma (onasemnogene abeparvovec) Receives MHLW’s Approval for Spinal Muscular Atrophy

The post Novartis Reports Results of Zolgensma in P-III STR1VE-EU Study for SMA Type 1 first appeared on PharmaShots.

PharmaShots Weekly Snapshot (Aug 24 -28, 2020)

1. Taysha Gene Therapies’ TSHA-101 Receives the US FDA’s Orphan Drug Designation and Rare Pediatric Disease Designation for GM2 Gangliosidosis

Published: Aug 27, 2020 | Tags:  Taysha Gene Therapies, TSHA-101, Receives, US, FDA, Orphan Drug Designation, Rare Pediatric Disease Designation, GM2 Gangliosidosis

2. Bayer Reports the NDA Submission to NMPA for Vericiguat to Treat Chronic Heart Failure in China

Published: Aug 28, 2020 | Tags:  Bayer, Reports, NDA, Submission, NMPA, Chronic Heart Failure, China, Vericiguat

3. Galecto’s GB0139 Receives the US FDA’s and EMA’s Orphan Drug Designations for Idiopathic Pulmonary Fibrosis

Published: Aug 27, 2020 | Tags: Galecto, GB0139, Receives, US, FDA, EMA, Orphan Drug Designations, Idiopathic Pulmonary Fibrosis

4. Philips to Acquire Intact Vascular for $360M

Published: Aug 27, 2020 | Tags: Philips, Acquire, Intact Vascular, $360M

5. BioNTech and Fosun Pharma to Supply ~10M Doses of COVID-19 Vaccine to Hong Kong and Macao

Published: Aug 27, 2020 | Tags: BioNTech, Fosun Pharma,  Supply, ~10M, Doses, COVID-19 Vaccine, Hong Kong, Macao

6. Amazon Enters into Fitness Space with the Launch of Halo Band and App

Published: Aug 27, 2020 | Tags: Amazon, Enters, Fitness Space, Launch, Halo Band

7. BeiGene Signs an Exclusive License Agreement with Singlomics for Neutralizing COVID-19 Antibodies

Published: Aug 27, 2020 | Tags: BeiGene, Signs, Exclusive, License Agreement, Singlomics, Neutralizing, COVID-19, Antibodies

8. Abbott’s BinaxNOW COVID-19 Ag Card Receives the US FDA’s EUA to Detect COVID-19

Published: Aug 27, 2020 | Tags: Abbott, BinaxNOW COVID-19 Ag Card, Receives, US, FDA, EUA, Detect, COVID-19

9. FDC Launches Two Variants of Favipiravir for COVID-19 in India

Published: Aug 26, 2020 | Tags:  FDC, Launches, Two Variants, Favipiravir, COVID-19, India

10. Celltrion Initiates P-I Study of CT-P59 Against COVID-19 in Korea

Published: Aug 26, 2020 | Tags:  Celltrion, Initiates, P-I, Study, CT-P59, COVID-19, Korea

11. GSK’s Blenrep (belantamab mafodotin) Receives EC’s Approval for R/R Multiple Myeloma

Published: Aug 26, 2020 | Tags:  GSK, Blenrep, (belantamab mafodotin), Receives, EC’s, Approval, R/R, Multiple Myeloma

12. Lupin and Mylan Launch Nepexto (biosimilar, etanercept) in Germany

Published: Aug 26, 2020 | Tags: Fitbit, Report, Results, COVID-19, Study, Early, Detection, Diseases

13. Takeda Collaborates with Engitix to Target Fibrotic Liver Diseases

Published: Aug 26, 2020 | Tags: Takeda, Collaborates, Engitix, Target, Fibrotic Liver Diseases

14. Philips and B. Braun’s Onvision Needle Tip Tracking Technology Receive the US FDA’s 510 (k) Clearance for Regional Anesthesia

Published: Aug 25, 2020 | Tags: Philips, B. Braun, Onvision Needle Tip Tracking Technology, Receive, US, FDA, 510 (k) Clearance, Regional Anesthesia

15. Qiagen to Launch Digital Test for Detecting SARS-CoV-2 Antibodies in the US

Published: Aug 25, 2020 | Tags: Qiagen, Launch, Digital Test, Detecting, SARS-CoV-2, Antibodies, US

16. Novartis Reports Results of Asciminib (ABL001) in P-III ASCEMBL Study for Chronic Myeloid Leukemia

Published: Aug 26, 2020 | Tags: Novartis, Reports, Results, Asciminib, (ABL001), P-III, ASCEMBL Study, Chronic Myeloid Leukemia

17. Takeda and OVID Report Results of Soticlestat (TAK-935/OV935) in P-II ELEKTRA Study for Dravet Syndrome or Lennox-Gastaut Syndrome

Published: Aug 25, 2020 | Tags: Takeda, OVID, Report, Results, Soticlestat, TAK-935/OV935, P-II, ELEKTRA Study, Dravet Syndrome, Lennox-Gastaut Syndrome

18. ACADIA Acquires CerSci Therapeutics for $52.5M

Published: Aug 25, 2020 | Tags: ACADIA, Acquires, CerSci Therapeutics, $52.5M

19. AbbVie and Harvard University Collaborate to Develop Novel Therapies Against Emergent Viral Diseases

Published: Aug 25, 2020 | Tags: AbbVie, Harvard University, Collaborate, Develop, Novel Therapies, Against, Emergent Viral Diseases

20. AbbVie Exercises its Option to License Morphosys’ αvβ6 Integrin Inhibitor Program for Fibrotic Disease

Published: Aug 24, 2020 | Tags: AbbVie, Exercises, License, Option, Morphosys, αvβ6 Integrin, Inhibitor Program, Fibrotic Disease

21. BeiGene Signs a License and Supply Agreement with Bio-Thera for BAT1706 (biosimilar, bevacizumab) in China

Published: Aug 24, 2020 | Tags: BeiGene, Signs, License, Supply, Agreement, Bio-Thera, BAT1706, biosimilar, bevacizumab, China

22. AstraZeneca Initiates P-I Study of AZD7442 Against COVID-19

Published: Aug 25, 2020 | Tags: AstraZeneca, Initiates, P-I, Study, AZD7442, Against, COVID-19

23. Merck’s Keytruda (pembrolizumab) Receives Two New PMDA’s Approvals in Japan

Published: Aug 24, 2020 | Tags: Merck, Keytruda, (pembrolizumab), Receives, PMDA, Approvals, Japan

24. Bionano Genomics Acquires Lineagen to Facilitate the Clinical Adoption of Saphyr for Digital Cytogenetics

Published: Aug 24, 2020 | Tags: Bionano, Genomics, Acquires, Lineagen, Facilitate, Clinical Adoption, Saphyr, Digital Cytogenetics

26. Bayer and One Drop Collaborate to Develop Digital Therapies Across Multiple Therapeutic Areas

Published: Aug 24, 2020 | Tags:  Bayer, One Drop, Collaborate, Develop, Digital Therapies, Across, Multiple, Therapeutic Areas

27. BMS to Acquire Forbius for its AVID200 to Expand its Footprints in Oncology and Fibrosis

Published: Aug 24, 2020 | Tags: BMS, Acquire, Forbius, Adding, TGF-beta Inhibitor, Portfolio

28.  Novartis’ Triple Regimen Fails to Meet the Primary Endpoint in P-III COMBI-i Study for Advanced Melanoma

Published: Aug 23, 2020 | Tags: Novartis, Triple Regimen, Fails, Meet, Primary Endpoint, P-III, COMBI-I, Study, Advanced Melanoma

29. ReiThera Reports First Patient Dosing with its COVID-19 Vaccine Candidate in Italy

Published: Aug 24, 2020 | Tags: ReiThera, Reports, First, Patient Dosing, COVID-19, Vaccine Candidate, Italy

30. Takeda to Divest its Consumer Health Unit to Blackstone for $2.3B in Japan

Published: Aug 24, 2020 | Tags:  Takeda, Divest, Consumer Health Unit, Blackstone,  $2.3B, Japan

31. Chugai’s Kadcyla (trastuzumab emtansine) Receives MHLW’s Approval for Adjuvant Therapy of HER2-Positive Early Breast Cancer

Published: Aug 23, 2020 | Tags: Chugai, Kadcyla, (trastuzumab emtansine), Receives, MHLW, Approval, Adjuvant Therapy, HER2-Positive, Early Breast Cancer

32. Vertex’s Kaftrio + Ivacaftor Receive the EC’s Approval to Treat Cystic Fibrosis in People Aged 12 Years and Older

Published: Aug 22, 2020 | Tags: Vertex, Kaftrio, Ivacaftor, Receive, EC, Approval, Cystic Fibrosis, Aged, 12 Years, Older

32. AstraZeneca Collaborates with RenalytixAI to Develop Precision Medicine for Chronic Diseases

Published: Aug 22, 2020 | Tags: AstraZeneca, Collaborates, RenalytixAI, Develop, Precision Medicine, Chronic Diseases

FDA starts quick review of Merck’s MET-targeting lung cancer drug

Merck KGaA could be looking at an early 2021 approval for its MET inhibitor tepotinib in lung cancer from the FDA after the US regulator started a priority review of the drug, but could still be beaten to market by a rival drug.

Tepotinib has been developed to treat non-small cell lung cancer (NSCLC) with MET exon 14 (METex14) mutations, which occur in 3% to 5% of all cases of this form of lung cancer. It picked up its first world approval – as Tepmetko – in  Japan earlier this year.

The once-daily oral drug was awarded breakthrough status by the FDA last year for METex14-positive NSCLC patients who had progressed after first-line platinum-based chemotherapy, a week after the US regulator gave the same designation to another MET inhibitor – capmatinib – from Incyte/Novartis.

Capmatinib beat tepotinib to the US market, getting FDA approval in May under the Tabrecta trade name for all patients with METex14-positive NSCLC, regardless of whether or not they have received prior treatment. Merck is also seeking approval for a “line-agnostic” indication for its drug.

Merck’s filing comes on the back of a phase 2 study – called VISION – which enrolled patients with METex14-positive NSCLC diagnosed using an assay developed by ArcherDX that can detect the mutation from a blood test or tumour biopsy.

Tepotinib treatment achieved an objective response rate (ORR) of 48% among patients diagnosed using a blood test and 50% in the biopsy group, with a median duration of response of just over 11 months.

Tabrecta was approved based on the GEOMETRY mono-1 trial, which found a 68% ORR in patients treated with the drug first-line, with a 12.6 month median duration, and 41% among previously-treated patients with a duration of 9.7 months.

Novartis and Incyte’s drug was approved alongside a companion diagnostic developed by Foundation Medicine.

“METex14 skipping alterations drive a particularly aggressive form of NSCLC in a patient population that is generally elderly, facing poor clinical prognosis and in urgent need of new therapeutic options,” said Luciano Rossetti, Merck’s head of R&D.

Other MET inhibitors are also coming through development, including AstraZeneca’s savolitinib, which is being developed initially for NSCLC patients who have progressed after treatment with AZ’s EGFR inhibitor Tagrisso (osimertinib), and as a combination therapy for NSCLC.

MET is a recognised resistance pathway in EGFR-positive NSCLC, and earlier this year AZ reported preliminary data showing that the Tagrisso/savolitinib combination was well-tolerated in patients who had failed first-line EGFR drugs and was able to achieve partial responses in up to 48% of patients.

Merck is also exploring this application with tepotinib, and has a trial of its drug alongside Tagrisso.

The post FDA starts quick review of Merck’s MET-targeting lung cancer drug appeared first on .

Novartis eyes filings for leukaemia drug asciminib after phase 3 win

A first-in-class STAMP inhibitor developed by Novartis – asciminib – has outperformed a current drug for chronic myeloid leukaemia (CML) in a head-to-head trial, setting up regulatory filings.

The ASCEMBL trial compared asciminib (ABL001) to Pfizer’s Bosulif (bosutinib) in Philadelphia chromosome-positive CML patients who had previously been treated with two or more tyrosine kinase inhibitors (TKIs), the go-to treatment for this form of CML.

Current treatment for these patients relies on first-generation TKI imatinib – sold by Novartis as Glivec but also available as a generic – as well as second-generation drugs such as Bosulif, Bristol-Myers Squibb’s Sprycel (dasatinib) and Novartis’ Tasigna (nilotinib).

These drugs have transformed the prospects of people with CML, but most patients eventually see their cancer progress despite TKI therapy, and resistance to these drugs can lead to treatment failures. They can also be hard to tolerate, as they can affect healthy as well as leukaemic cells.

Asciminib’s novel mechanism of blocking STAMP – the ABL myristoyl pocket of the BCR-ABL tyrosine kinase – could sidestep conventional TKI resistance and side effects and provide a new third-line treatment option for CML patients, says Novartis.

In ASCEMBL, asciminib was better than Bosulif at achieving a major molecular response (MMR) at 24 weeks than Bosulif in Ph+ CML patients in chronic phase, the stage of the disease when the blood and bone marrow contains less than 10% malignant cells.

Molecular response is measured using a genetic probe to detect BCR-ABL gene mutations in blood or bone marrow based on the number of leukaemic cells present, and is considered to be MMR when the mutations are found at a rate of 1/1000th or less than would be expected in an untreated patient.

“Our ability to treat patients with TKIs changed CML care forever. However, the risk of disease progression is a reality for many patients,” said Novartis’ chief medical officer John Tsai.

“These results with asciminib are a testament to our commitment to further transform CML care – this time through STAMP inhibition, by exploiting a natural regulatory mechanism of the ABL kinase,” he added.

The FDA has awarded the drug fast-track status, given to new therapies that treat a serious or life-threatening condition and fill an unmet medical need, which means it could be eligible for a speedy review after filing.

Novartis originally planned to go after approval as a second-line treatment option as well on the back of another trial called ASC4MORE, but is sticking with third-line for the time being.

Data from the ASCEMBL trial will be submitted for presentation at an upcoming medical meeting, and results will be shared with regulatory authorities, said the drugmaker.

If approved, asciminib would beef up Novartis’ CML portfolio, which is a big earner for the company. Tasigna made sales of $1.8 billion last year, and despite generics Glivec is still a blockbuster brand for the company, adding almost $1.3 billion to its 2019 revenues.

The post Novartis eyes filings for leukaemia drug asciminib after phase 3 win appeared first on .

Novartis Reports Results of Asciminib (ABL001) in P-III ASCEMBL Study for Chronic Myeloid Leukemia

Shots:

  • The P-III ASCEMBL study involves assessing of Asciminib (ABL001) vs bosutinib in patients with Ph+ CML-CP, prior treated with two or more TKIs
  • The study met its 1EPs of superiority in major molecular response (MMR) rate @24wks.
  • Asciminib (ABL001) is an investigational treatment specifically targeting the ABL myristoyl pocket (STAMP), being evaluated in multiple clinical studies addressing the needs of CML patients. The US FDA has granted FT designation for the therapy

Click here ­to­ read full press release/ article | Ref: Novartis | Image: Fortune

Novartis’s Spartalizumab Combo Stubles; Union Therapeutics Doses In COVID-19 Trial; Yumanity To Merge With Proteostasis

Novartis’s Spartalizumab Combo Fails To Meet The Primary Goal In The Melanoma Trial 

Novartis recently declared the results of its Phase III COMBI-I trial evaluating its experimental checkpoint inhibitor spartalizumab in combination with Tafinlar (dabrafenib) and Mekinist (trametinib) for patients, previously untreated, with unresectable or metastatic BRAF V600 mutation-positive melanoma compared to Tafinlar and Mekinist alone. The results announced that the spartalizumab combo stumbled in the trial and failed to hit the primary endpoint of investigator-assessed progression-free survival in melanoma.

The drug, Spartalizumab, is an experimental monoclonal antibody designed as immunotherapy to target the human programmed death-1 (PD-1) receptor. Tafinlar and Mekinist are prescription treatments targeting melanoma, and or other cancers, including thyroid cancer.

The company will review the data further and plans to assess spartalizumab in other tumor types. Earlier this month, Novartis received the FDA recommendation for its Kesimpta (ofatumumab) for subcutaneous use for relapsing forms of multiple sclerosis (RMS). Moreover, the company also announced positive data from the Phase II ELARA trial of Kymriah (tisagenlecleucel) in patients with relapsed or refractory (r/r) follicular lymphoma (FL).

Union Therapeutics A/S Announces Completion Of Dosing Of Healthy Volunteers With UNI911 For COVID-19

Union Therapeutics announced successful completion of dosing healthy volunteers with UNI911. The study was a double-blind, placebo-controlled, randomized study, where ascending single and multiple dosing regimens were given to 44 healthy volunteers. The goal of the study was to assess the efficiency and safety of UNI911 in COVID-19 patients. 

UNI911 was administered as an inhalation treatment candidate for COVID-19 across five cohorts. The drug uses an optimized salt form of niclosamide, which is a safe oral drug and is in use for decades as an anthelmintic drug. The drug is directly delivered to lungs via inhalation to achieve high local exposures, and address the concerns of low oral bioavailability linked to niclosamide. 

Yumanity Therapeutics Plans To Merge With Proteostasis Therapeutics To Advance Neurodegenerative Disorders Pipeline

Yumanity Therapeutics has decided to merge its operations with Boston-based Proteostasis Therapeutics. The duo plans to advance the pipeline for neurodegenerative disorders including Parkinson’s disease. 

Both the companies have candidates that address the misfolded proteins at the root of disease. The companies will focus on Yumanity’s YTX-7739, which is in a Phase I trial for Parkinsons’ disease. Yumanity is also running trials for its candidates which are in different stages of clinical development for dementia with Lewy bodies, multi-system atrophy, amyotrophic lateral sclerosis (ALS) and frontotemporal lobar dementia (FTLD). Proteostasis, on the other hand, is looking for another deal for its proprietary CFTR modulators. 

The post Novartis’s Spartalizumab Combo Stubles; Union Therapeutics Doses In COVID-19 Trial; Yumanity To Merge With Proteostasis appeared first on DelveInsight Business Research.

Novartis’ Triple Regimen Fails to Meet the Primary Endpoint in P-III COMBI-i Study for Advanced Melanoma

Shots:

  • The P-III study involves assessing of spartalizumab (PDR001) + Tafinlar (dabrafenib) and Mekinist (trametinib) vs PBO + Tafinlar and Mekinist in previously untreated patients with unresectable or metastatic BRAF V600 mutation-positive melanoma
  • The study was conducted in three parts while today’s results are from part 3 of the trial. The study did not meet its 1EPS of investigator-assessed progression-free survival
  • Spartalizumab is mAb targeting PD-1 receptor while Tafinlar and Mekinist are prescription medicines, used in combination to prevent melanoma

Click here ­to­ read full press release/ article | Ref: Novartis | Image: CNBC

Blow for Novartis as PD-1 drug spartalizumab flunks trial

Novartis’ hopes of catching up with other companies in immuno-oncology have been dented after PD-1 inhibitor spartalizumab failed a phase 3 trial in skin cancer.

Novartis had hoped the COMBI-i trial would allow it to file for approval of the ‘me-too’ PD-1 inhibitor before the end of this year as part of a triple therapy for BRAF-mutated malignant melanoma alongside its targeted drugs Tafinlar (dabrafenib) and Mekinist (trametinib).

As it turned out, adding spartalizumab to treatment with the two targeted drugs failed to provide any improvement in the time patients lived without progression of their cancer.

Tafinlar/Mekinist are a blockbuster treatment regimen for BRAF-positive melanoma that added $737 million to Novartis’ coffers in the first half of the year, the third-largest oncology therapy in the company’s product line.

The Swiss drugmaker had hoped – despite spartalizumab coming to market well behind other PD-1/PD-L1 checkpoint inhibitors – that piggybacking on its established therapy would give it a rapid route to market and an indication free of competition from other drugs in the class like Merck & Co’s Keytruda (pembrolizumab) and Bristol-Myers Squibb’s Opdivo (nivolumab).

Prospects for the triplet therapy looked good as recently as this year’s virtual ASCO congress, when preliminary data from COMBI-I showed that the regimen eliminated tumours in 44% of patients, with an overall response rate of 78%.

Those results came from an open-label portion of the trial, however, and at the time Novartis said the results couldn’t be considered conclusive.

Novartis has not released the figures from the latest, randomised portion of the study, but said in a statement that the data “give us valuable insights into the role the investigational immunotherapy spartalizumab may play in future cancer therapy combinations.”

Merck has also tested the combination of Keytruda with Tafinlar/Mekinist in the KEYNOTE-022, which also involved BRAF-positive melanoma patients and used a similar design. Results released in 2018 showed some signs of efficacy, but also failed to reach statistical significance and on the basis of overall response rates the triple did worse than Tafinlar/Mekinist.

There’s no shortage of other trials on the go that could resurrect spartalizumab’s fortunes, but there’s no question that the COMBI-I failure has slammed the brakes on its progress to market.

The company has mid-stage trials of the PD-1 inhibitor on the go as a combination therapy with CSF-1 inhibitor BLZ945 in solid tumours, c-Met inhibitor capmatinib in liver cancer, and Palobiofarma’s adenosine A2A receptor inhibitor taminadenant (NIR178) in various cancer indications.

With six PD-1/PD-L1 inhibitors on the market – and the most recent entrants struggling to make headway sales-wise – there has been speculation that latecomers like Novartis, Eli Lilly and GlaxoSmithKline will be consigned to niche status.

The post Blow for Novartis as PD-1 drug spartalizumab flunks trial appeared first on .

Mission successful for Novartis after FDA approves ofatumumab in MS

It’s mission accomplished for Novartis after the FDA approved ofatumumab for multiple sclerosis, completing a project where the former cancer drug has been repurposed.

The FDA approved ofatumumab under the brand name Kesimpta for people living with relapsing forms of multiple sclerosis.

Kesimpta will have a list price of around $83,000 a year, which the company argues will make it one of the lowest-cost branded options in a highly competitive market where drugs like Sanofi’s Aubagio and Roche’s Ocrevus have strong footholds.

Novartis is also talking up Kesimpta’s “favourable” safety profile and an injector pen that allows the drug to be administered each month at home.

The company hopes this will give it a competitive advantage over Roche’s Ocrevus (ocrelizumab), which is given as an infusion every six months in a hospital clinic after two starter doses two weeks apart.

Novartis also pointed to trial data showing better efficacy and similar safety profile when compared with Sanofi’s oral MS drug Aubagio (teriflunomide).

Ofatumumab was first approved by the FDA as a cancer drug in chronic lymphocytic leukaemia (CLL), under the brand name Arzerra, in 2014 when it was owned by GlaxoSmithKline.

But Novartis took control of ofatumumab in 2015 as part of an asset-swap deal, picking up rights to its other uses in autoimmune diseases such as MS, and has completed a research project lasting around 10 years to reimagine the drug as a treatment for MS.

Patients taking the drug for CLL in the US will be transitioned over to an access programme at no cost.

Novartis will pay co-developer Genmab a lump sum of $30 million as payment for lost royalties.

Kesimpta works by targeting B-cells, which are the underlying cause of both multiple sclerosis and several kinds of blood cancer including CLL.

Approval of Kesimpta is based on results from the phase 3 ASCLEPIOS I and II studies, in which it demonstrated superiority versus Aubagio in significantly reducing the annualised relapse rate, three-month confirmed disability progression, and the number of gadolinium-enhancing T1 and new or enlarging T2 lesions.

The post Mission successful for Novartis after FDA approves ofatumumab in MS appeared first on .

Novartis’ Kesimpta (ofatumumab) Receives the US FDA’s Approval as the First Self-Administered Therapy for Relapsing Multiple Sclerosis

Shots:

  • The approval is based on P-III ASCLEPIOS I & II studies assessing Kesimpta (20mg, monthly, SC) vs teriflunomide (14mg, qd) in 1,882 patients aged 18-55yrs. with RMS with an EDSS b/w 0 and 5.5 across 37 countries. Additionally, P-II APLIOS study determine the bioequivalence of subcutaneous delivery of Kesimpta via a prefilled syringe and a Sensoready pen in patients with RMS
  • ASCLEPIOS I & II studies results: reduction in ARR 51% & 59% (0.11 vs 0.22) & (0.10 vs 0.25), 34% reduction in 3mos CDP, reduction in number of Gd+ T1 (98% & 94%) and new/ enlarging T2 lesions (82% & 85%) respectively
  • In a post hoc analysis, Kesimpta may halt new disease activity in RMS with 47.0% & 7.8% of patients achieved (NEDA-3) within (0–12mos.) and (12–24 mos.) of treatment, respectively. The therapy is expected to be available in the US in early Sept’2020 along with its anticipated EU approval in Q2’21

Click here ­to­ read full press release/ article | Ref: Novartis | Image: KRCU

PharmaShots Weekly Snapshot (Aug 10 – 14, 2020)

1. Roche’s Evrysdi (risdiplam) Receives the US FDA’s Approval for SMA in Adults and Children

Published: Aug 10, 2020 | Tags: Roche, Evrysdi, risdiplam, Receives, US, FDA, Approval, SMA, Adults, Children

2.  The US FDA Approves Guardant360 CDx as the First Liquid Biopsy NGS Assay to Identify EGFR Mutations in Non-Small Cell Lung Cancer

Published: Aug 07, 2020 | Tags: Guardant Health, Guardant360 CDx, Receives, US, FDA, Approval, First, Liquid Biopsy, NGS, Assay, Identify, EGFR, Mutations, Non-Small Cell Lung Cancer

 3. Roche Report Mixed Results of Etrolizumab in P-III Studies for Patients with Moderately to Severely Active Ulcerative Colitis

Published: Aug 10, 2020 | Tags: Roche, Report, Mixed Results, Etrolizumab, P-III, Studies, Patients, Moderately, Severely, Active, Ulcerative Colitis

4. Boehringer Ingelheim Acquires GST to Boost its Stem Cell Capabilities in Animal Health

Published: Aug 10, 2020 | Tags: Boehringer Ingelheim, Acquires, GST, Boost, Stem Cell Capabilities, Animal Health

5. Gilead Reports NDA Submission to the US FDA for Veklury (Remdesivir) to Treat COVID-19

Published: Aug 11, 2020 | Tags: Gilead, Reports, NDA, Submission, US, FDA, Veklury, Remdesivir, Treat, COVID-19

6. Samsung Bioepis Launches Ontruzant (trastuzumab, biosimilar) for Early and Metastatic HER2-Overexpressing Breast Cancer in Brazil

Published: Aug 11, 2020 | Tags: Samsung Bioepis, Launches, Ontruzant, trastuzumab, biosimilar, Early, Metastatic, HER2-Overexpressing, Breast Cancer, Brazil

7. Olympus to Acquire Arc Medical Design for Expanding its Product Portfolio

Published: Aug 10, 2020 | Tags: Olympus, Acquire, Arc Medical Design, Expand, Portfolio

8.  Bayer to Acquire KaNDy Therapeutics for Augmenting its Women’s Healthcare Portfolio

Published: Aug 11, 2020 | Tags: Bayer, Acquire, KaNDy Therapeutics, Augment, Women’s Healthcare, Portfolio

9.  Ligand to Acquire Pfenex for $516M

Published: Aug 11, 2020 | Tags: Ligand, Acquire, Pfenex, $516M

10. Medtronic to Acquire Companion Medical for Adding Smart Insulin Pen to its Diabetes Unit

Published: Aug 11, 2020 | Tags: Medtronic, Acquire, Companion Medical, Smart Insulin Pen, Diabetes Unit

11. BMS’ Opdivo (nivolumab) + Yervoy (ipilimumab) + CT Receive Health Canada Approval for Metastatic Non-Small Cell Lung Cancer

Published: Aug 11, 2020 | Tags: BMS, Opdivo, nivolumab, Yervoy, ipilimumab, CT, Receive, Health Canada, Approval, Metastatic, Non-Small Cell Lung Cancer

12. Sarepta Therapeutics Collaborates with University of Florida to Accelerate the Development of Therapies for Rare Genetic Diseases

Published: Aug 12, 2020 | Tags: Sarepta Therapeutics, Collaborates, University of Florida, Accelerate, Development, Therapies, Rare Genetic Diseases

13.  Innovent and Eli Lilly Report sNDA Acceptance of Tyvyt (sintilimab) Combination Regimen as 1L Therapy in Squamous Non-Small Cell Lung Cancer in China

Published: Aug 12, 2020 | Tags: Innovent, Eli Lilly, Report, sNDA, Acceptance, Tyvyt, sintilimab, Combination Regimen, 1L Therapy, in Squamous, Non-Small Cell Lung Cancer, China

14. Roche Collaborates with Celleron Therapeutics for Emactuzumab to Treat Patients with Tenosynovial Giant Cell Tumor

Published: Aug 12, 2020 | Tags: Roche, Collaborates, Celleron Therapeutics, Emactuzumab, Patients with Tenosynovial Giant Cell Tumor

15. Regeneron Reports the US FDA’s Acceptance of Evinacumab’s BLA for Priority Review as a Treatment for Patients with HoFH

Published: Aug 13, 2020 | Tags: Regeneron, Reports, US, FDA, Acceptance, Evinacumab, BLA, Priority Review, Treatment, Patients, HoFH

16Roche Reports the US FDA’s Acceptance of sBLA for Xolair (omalizumab) Prefilled Syringe for Self-Administration Across All Indications

Published: Aug 13, 2020 | Tags: Roche, Reports, US, FDA, Acceptance, sBLA,  Xolair, (omalizumab), Prefilled Syringe, Self-Administration, Across, All, Indications

17.   Zydus Launches Cheapest Version of Remdesivir at $37.41 per Vial in India

Published: Aug 13, 2020 | Tags:  Zydus, Launches, Remdac, (remdesivir), $37.41, Vial, India

18.   Novo Nordisk Resumes P-III Study of Concizumab for Patients with Hemophilia A and B

Published: Aug 13, 2020 | Tags: Novo Nordisk, Resumes, P-III, Study, Concizumab, Patients, Hemophilia A and B

19.  Alphabet’s Verily Establishes CLIA-Certified Lab Focusing on COVID-19 Testing

Published: Aug 11, 2020 | Tags: Alphabet, Verily, Establishes, CLIA-Certified, Lab, Focusing, COVID-19, Testing

20.   Strata Oncology Collaborates with Mirati Therapeutics to Broaden Enrollment Clinical Trial of MRTX849 for Patients with Advanced Solid Tumors

Published: Aug 13, 2020 | Tags: Strata Oncology, Collaborates, Mirati Therapeutics, Broaden, Enrollment, Clinical Trial, MRTX849, Patients,  Advanced Solid Tumors

21.  AstraZeneca to Initiate Production of its COVID-19 Vaccine Early in 2021

Published: Aug 13, 2020 | Tags:  AstraZeneca, Initiate, Production, COVID-19, Vaccine, Early, 2021

22. EC Concludes Exploratory Talks with J&J to Supply 200M Doses of COVID-19 Vaccine

Published: Aug 13, 2020 | Tags: Johnson & Johnson, EC, Supply, 200M, Doses, COVID-19, Vaccine

23.  SK bioscience Collaborate with Novavax to Supply Antigen for COVID-19 Vaccine

Published: Aug 14, 2020 | Tags: Novavax, SK bioscience, Collaborate, NVX-CoV2373, Treat, COVID-19

24. Novavax Collaborates with UK Government to Supply 60M Doses of NVX-CoV2373 to Combat COVID-19

Published: Aug 14, 2020 | Tags: Novavax, Collaborates, UK Government, Supply, 60M, Doses,  NVX-CoV2373, Combat, COVID-19

25. Solasia Signs a License Agreement with Isofol to Develop and Commercialize Arfolitixorin for mCRC in Japan

Published: Aug 13, 2020 | Tags: Solasia, Signs, License Agreement, Isofol, Develop, Commercialize, Arfolitixorin, mCRC, Japan

Related Post: PharmaShots Weekly Snapshot (Aug 03- 07, 2020)

Roche takes on pricey rivals as FDA approves SMA drug

Roche is hoping to undercut hugely expensive rivals after the FDA approved its oral spinal muscular atrophy (SMA) drug Evrysdi (risdiplam).

Evrysdi is the third treatment approved for SMA, an ultra-rare muscle wasting disease that can begin in early childhood, after Biogen’s Spinraza (nusinersen) and Novartis’ Zolgensma (onasemnogene abeparvovec).

But Spinraza costs $750,000 in the first year of treatment and about half that price annually from then on.

Zolgensma costs about $2.1m for a single shot of the gene therapy, making it the most expensive drug in the world by many people’s reckoning, although the manufacturer argues this is justified given the costs of treating the condition in later life.

Roche has decided to price Evrysdi according to its weight, costing up to $340,000 per year, with the cost being under $100,000 annually for some younger patients.

While this is not cheap by anybody’s reckoning, Roche hopes that the less intimidating price tag, plus the patient-friendly oral administration method will give it a competitive edge.

The FDA approved Evrysdi for the treatment of spinal muscular atrophy (SMA) in adults and children two months of age and older.

Roche noted that Evrysdi showed clinically-meaningful improvements in motor function across two clinical trials in people with varying ages and levels of disease severity, including Types 1, 2, and 3 SMA.

Infants achieved the ability to sit without support for at least five seconds, a key motor milestone not normally seen in the natural course of the disease.

Evrysdi also improved survival without permanent ventilation at 12 and 23 months, compared to natural history.

A liquid medicine, Evrysdi is administered daily at home by mouth or feeding tube.

Evrysdi is designed to treat SMA by increasing production of the survival of the motor neuron (SMN) protein. SMN protein is found throughout the body and is critical for maintaining healthy motor neurons and movement.

Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics.

Evrysdi will be available in the US within two weeks for direct delivery to patients’ homes through Accredo Health Group, an Express Scripts specialty pharmacy.

The post Roche takes on pricey rivals as FDA approves SMA drug appeared first on .

Cerner Invests in Xealth to Jointly Develop Digital Health Solutions for Clinicians

Digital Prescribing Platform Xealth Raises $11M to Expand Digital Health Tools

What You Should Know:

– Cerner and Xealth announce a collaboration to foster
tighter physician-patient relationships by giving patients easier access to
digital health tools.

– These assets will be prescribed directly within the physician’s EHR workflow to manage conditions including chronic diseases, behavioral health, maternity care, and surgery preparation.

– Cerner and LRVHealth have together invested $6 million
in Xealth as part of this agreement, with Cerner and Xealth planning to jointly
develop digital health solutions that extend the value of the EHR.

– Already integrated into Epic, the integration puts
Xealth in the EHR of record for more than half of the U.S. hospital systems.


Xealth, a Seattle, WA-based company enabling digital
health at scale, and Cerner
Corporation
, today announced a collaboration that will bring digital
health tools to clinicians and patients to improve the healthcare experience.
As part of this agreement, Cerner and Xealth plan to jointly develop digital health
solutions that extend the value of the electronic health record
(EHR).
Already integrated into Epic, this integration puts Xealth in
the EHR of record for more than half of the U.S. hospital systems.

In addition, Cerner
and LRVHealth have together invested $6M in Xealth. Cerner joins Xealth
investors including Atrium Health, Cleveland Clinic, Froedtert and the Medical College of Wisconsin, MemorialCare Innovation Fund, Providence
Ventures and UPMC as well as McKesson, Novartis, Philips, and ResMed.

Xealth/Cerner EHR
Integration Details

At its core, the
relationship between Xealth and Cerner aims to give patients their own digital
data so they can be more engaged in their treatment plans. The Xealth platform
is designed to help clinicians easily integrate, prescribe and monitor digital health
tools for patients from one location in the EHR. Care teams will be able to
order solutions directly from the EHR to manage conditions including chronic
diseases, behavioral health, maternity care and surgery preparation. Incorporating Xealth into Cerner’s technology and patient portal
provides easier access to personal health information and gives care teams the
ability to monitor patient engagement with the tools and analyze the effects of
increased engagement on their healthcare and recovery.

The collaboration
between Cerner and Xealth will provide care teams and patients convenience and
help improve care accessibility. Better communications and engagement with key
members of their care team will create an experience that is connected across
settings before, during and after a care encounter.

Why It Matters

During the recent
surge of COVID-19 across the world, tools that automate patient education,
deliver virtual care, support telehealth and offer remote patient monitoring
have become even more prominent, creating new methods to inform care decisions
and keep care teams and patients connected.

“Today, we have the unique opportunity to improve people’s lives by allowing active participation in their own treatment plans,” said David Bradshaw, Senior Vice President, Consumer and Employer Solutions, Cerner. “Patients want greater access to their health information and are motivated to help care teams find the most appropriate road to recovery. Xealth and Cerner are making it easier and more convenient for patients and clinicians to accelerate healthcare in a more consumer-centric experience.”

Incorporating Xealth’s
digital health platform with clinician recommendations has been shown to
increase patient engagement rates as compared to a direct to consumer approach.
The company powers more than 30 digital health solutions, connecting patients
with educational content, remote patient monitoring, virtual care platforms,
e-commerce product recommendations and other services needed to improve health
outcomes.

“In order for digital health to have lasting impact, it needs to show value and ease for both the care team and patient,” said Mike McSherry, CEO and Co-Founder of Xealth. “We strongly believe that technology should nurture deeper patient-provider relationships and facilitate information sharing across systems and the care settings. It is exciting work with Cerner to simplify meaningful digital health for its health partners.”

“Combining our expertise in developing interactive digital solutions that improve the patient experience with Cerner’s world-class platforms creates immense opportunity for our clients to better meet the needs of today’s highly connected healthcare consumer,” concluded McSherry.

Novartis Reports Results of Ofatumumab (OMB157) in P-III ASCLEPIOS Trials for Relapsing Multiple Sclerosis

Shots:

  • The two P-III studies, ASCLEPIOS I & II involves assessing of ofatumumab (20mg, monthly SC) vs teriflunomide (14mg) in 1882 patients aged 18-55yrs with MS and EDDS score b/w 0 and 5.5.  The studies were conducted across 37 countries in 350+ sites 
  • Results of ASCLEPIOS I & II: 51% & 58% reduction in ARR (0.11 vs 0.22 & 0.10 vs 0.25); reduction Gd+T1 lesions (97% & 94%); reduction in new or enlarging T2 lesions (82% & 85%); superior in reducing neuroaxonal damage in both studies, as measured by NfL serum concentrations; 34% and 32% risk reduction in 3mos. and 6mos. CDW; favorable trend in rate of 6mos. CDI; no difference in annual rate of brain volume loss
  • Ofatumumab (SC, once monthly) is a CD20 mAb, targeting CD20 molecule on the B-cell surface and inducing potent B-cell lysis and depletion with its anticipated US FDA’s approval in Sept’20 and in EU by Q2’21

Click here ­to­ read full press release/ article | Ref: Novartis | Image: Clinical Trial Arena

Related News: The US FDA Extends Review of sBLA of Ofatumumab (OMB157) for Patients with Relapsing Multiple Sclerosis




Novartis plans to seek approval for CAR-T in slow-growing lymphoma after Phase II success

The company said the study of Kymriah in follicular lymphoma met its primary endpoint, though it did not disclose the trial data. It plans to submit approval applications to the FDA and EMA next year.

Novartis Reports Results of Kymriah (tisagenlecleucel) in P-II ELARA Study for Follicular Lymphoma

Shots:

  • The P-II ELARA study involves assessing the efficacy and safety of Kymriah in adult patients with r/r FL across 12 countries in 30 sites globally
  • At the interim analysis, the study met its 1EPs of CRR, as assessed by IRC. The company will include the results in regulatory submissions, with anticipated filing to the US FDA in 2021, and then in EU, while the results will be presented at an upcoming medical meeting
  • Kymriah has received FDA’s RMAT designation in r/r FL based on preliminary ELARA trial findings, reflecting the unmet need for additional treatment options for FL. The Therapy was developed in collaboration with the Perelman School of Medicine at the University of Pennsylvania

Click here to­ read full press release/ article | Ref: Novartis | Image: Behance

Related News: Novartis’ Kymriah Receives NICE Approval for R/R Diffuse Large B-cell lymphoma (DLBCL) in Adults




PharmaShots Weekly Snapshot (Jul 27- 31, 2020)

 1.  Oxford Biomedica Signs Three Year Clinical Supply Agreement with Axovant to Manufacture and Supply AXO-Lenti-PD for Parkinson’s Disease 

Published: Jul 31, 2020 | Tags: Oxford Biomedica, Signs, Three Year, Clinical Supply Agreement, Axovant, Manufacture, Supply, AXO-Lenti-PD, Parkinson’s Disease

2.  Johnson & Johnson Initiates P-I/IIa Study of its Ad26.COV2.S Against COVID-19 in the US and Belgium

Published: Jul 30, 2020 | Tags: Johnson & Johnson, Initiates, P-I/IIa, Study,  Ad26,  US, Belgium

 3. Roche Receives the US FDA’s Approval for VENTANA HER2 Dual ISH Test as CDx to Identify Breast Cancer

Published: Jul 31, 2020 | Tags: Roche, Receives, US, FDA, Approval, VENTANA HER2 Dual ISH Test, CDx, Identify, Breast Cancer

4. Takeda’s Pevonedistat Receives the US FDA’s Breakthrough Therapy Designation to Treat Patients with Higher-Risk Myelodysplastic Syndrome

Published: Jul 31, 2020 | Tags: Takeda, Pevonedistat, Receives, US, FDA, Breakthrough Therapy Designation, Patients, Higher-Risk Myelodysplastic Syndromes, HR-MDS

5. Roche’s Tecentriq + Cotellic and Zelboraf Receives the US FDA’s Approval for Patients with Advanced Melanoma

Published: Jul 31, 2020 | Tags: Roche, Tecentriq, Cotellic, Zelboraf, Receives, US, FDA, Approval, Patients, Advanced, Melanoma

6. Sangamo Signs a Worldwide License Agreement with Novartis to Develop Genomic Therapies for Three Neurodevelopmental Targets

Published: Jul 30, 2020 | Tags: Sangamo, Signs, Worldwide, License Agreement, Novartis, Develop, Genomic Therapies, Three, Neurodevelopmental Targets

7.  Eli Lilly Reports Results of Jardiance (empagliflozin) in P-III EMPEROR Trial for Heart Failure Patients with Reduced Ejection Fraction with and without Diabetes

Published: Jul 30, 2020 | Tags: Eli Lilly, Reports, Results, Jardiance, empagliflozin, P-III, EMPEROR Trial, Heart Failure, Patients, Reduced Ejection Fraction, with and without, Diabetes

8.  AstraZeneca’s Tagrisso (osimertinib) Receives the US FDA’s BT Designation for the Adjuvant Treatment of Patients with Stage IB-IIIA EGFR-Mutated Lung Cancer

Published: Jul 29, 2020 | Tags: AstraZeneca, Tagrisso, Osimertinib, Receives, US, FDA, BT, Designation, Adjuvant Treatment, Patients, Stage IB-IIIA EGFR-Mutated, Lung Cancer

9. Henlius and Accord’s Zercepac (trastuzumab, biosimilar) Receive the EMA Approval for HER2-Positive Breast Cancer and Gastric Cancer

Published: Jul 30, 2020 | Tags: Glenmark, Report, Results, FabiFlu, favipiravir, P-III, Clinical Study, Patients, Mild, Moderate, COVID-19

10. UCB Canada’s Brivlera (brivaracetam) Receives Health Canada Approval to Treat Partial-Onset Seizures in Pediatric Epilepsy Patients

Published: Jul 29, 2020 | Tags: UCB Canada, Brivlera, brivaracetam, Receives, Health Canada, Approval, Treat, Partial-Onset Seizures, Pediatric, Epilepsy Patients

11. BARDA Signs a Multi-Year Agreement with Regeneron for its REGN-EB3 for National Preparedness

Published: Jul 23, 2020 | Tags: BARDA, Signs, Multi-Year Agreement, Regeneron, REGN-EB3, National Preparedness

13.  Baxter and Ayogo Expand their Partnership to Advance Digital Health Solution for Home Dialysis

Published: Jul 29, 2020 | Tags: Baxter, Ayogo, Expand, Partnership, Advance, Digital, Health Solution, Home Dialysis

14.  Merck’s MK-6482 Receives the US FDA’s Breakthrough Therapy Designation to Treat Patients With Von Hippel-Lindau Disease-Associated Renal Cell Carcinoma

Published: Jul 29, 2020 | Tags: Merck, MK-6482, Receives, US, FDA, Breakthrough Therapy Designation, Treat, Patients, Von Hippel-Lindau Disease- Associated, Renal Cell Carcinoma

15AbbVie Report Results of Rinvoq (upadacitinib) in a P-III AD Up Study for Patients with Atopic Dermatitis

Published: Jul 28, 2020 | Tags: AbbVie, Reports, Results, Rinvoq, upadacitinib, P-III, AD Up, Study, Patients, Atopic Dermatitis

16.   Roche’s Actemra/RoActemra (tocilizumab) Fails to Meet the Primary Endpoint in P-III COVACTA Study for Patients with COVID-19 Associated Pneumonia

Published: Jul 29, 2020 | Tags: Roche, Actemra/RoActemra, tocilizumab, Fails, Meet, Primary Endpoint, P-III, COVACTA Study, Patients, COVID-19, Associated Pneumonia

17.  Sanofi and GSK Sign an Agreement with the UK Government to Supply ~60M Doses of COVID-19 Vaccine

Published: Jul 28, 2020 | Tags: Sanofi, GSK, Sign, Agreement, UK, Government, Supply, ~60M, Doses, COVID-19, Vaccine

18.  Eli Lilly’s P-tau217 Blood Test Demonstrate High Accuracy in Diagnosis of Alzheimer’s Disease

Published: Jul 29, 2020 | Tags: Eli Lilly, P-tau217, Blood Test, Demonstrate, High Accuracy, Diagnosis, Alzheimer’s Disease

19.  Roche and UCB Collaborate to Develop UCB0107 for Alzheimer’s Disease

Published: Jul 28, 2020 | Tags: Roche, UCB, Collaborate, Develop, UCB0107,  Alzheimer’s Disease

20.  Zebra Medical Receives the US FDA’s Approval for its HealthMammo Mammography Tool

Published: Jul 27, 2020 | Tags: Zebra Medical, Receives, US, FDA, Approval, HealthMammo, Mammography Tool, Oncology, Breast Cancer

21.   AstraZeneca Report Results of Farxiga in P-III DAPA-CKD Study for Patients with Chronic Kidney Disease

Published: Jul 27, 2020 | Tags: AstraZeneca, Reports, Results, Farxiga, P-III, DAPA-CKD, Study, Patients, Chronic Kidney Disease

22.  Eli Lilly Amends its 2013 Agreement with Chi-Med to Commercialize Elunate (fruquintinib) in China

Published: Jul 28, 2020 | Tags: Eli Lilly, Amends, 2013, Agreement, Chi-Med, Commercialize, Elunate, Fruquintinib, China

23. AstraZeneca Signs an Agreement with Emergent BioSolutions to Expand Manufacturing of AZD1222 for COVID-19

Published: Jul 27, 2020 | Tags: AstraZeneca, Signs, Agreement, Emergent BioSolutions, Expand, Manufacturing, AZD1222, COVID-19

24.  Pfizer and BioNTech Initiate P-II/III Global Study of its Lead mRNA Vaccine Candidate Against COVID-19

Published: Jul 28, 2020 | Tags: Pfizer, BioNTech, Initiate, P-II/III, Global Study, Lead, mRNA, Vaccine, Candidate, Against, COVID-19

25.  Three Pharma Companies Launch Favipiravir to Treat COVID-19 in India

Published: Jul 26, 2020 | Tags:  Three, Pharma, Companies, Launch, Favipiravir, COVID-19, India

26. Kite’s Tecartus (brexucabtagene autoleucel) Receives the US FDA’s Approval as the First Cell-Based Gene Therapy for Relapsed or Refractory MCL

Published: Jul 27, 2020 | Tags: Kite, Tecartus, brexucabtagene autoleucel, Receives, US, FDA, Approval, First, Cell-Based, Gene Therapy, Relapsed, Refractory, MCL

27.   Centus Biotherapeutics’ Equidacent (bevacizumab, biosimilar) Receives CHMP’s Positive Opinion for the Treatment of Multiple Cancer Indications

Published: Jul 26, 2020 | Tags: Centus Biotherapeutics, Equidacent, (bevacizumab, biosimilar, Receives, CHMP, Positive Opinion, Treatment, Multiple Cancer Indications

28.   AstraZeneca Signs an Agreement with Daichii Sankyo to Develop and Commercialize DS-1062 Worth Up to $6B

Published: Jul 27, 2020 | Tags: AstraZeneca, Signs, Agreement, Daichii Sankyo, Develop, Commercialize, DS-1062, Worth, Up to, $6B, Global, Oncology,

29. Sorrento to Acquire SmartPharm and Develop Pipeline of Gene-Encoded Therapeutic Antibodies Targeting COVID-19 and Cancer

Published: Jul 27, 2020 | Tags: Sorrento, Acquire, SmartPharm, Develop, Pipeline, Gene-Encoded, Therapeutic Antibodies, Targeting, COVID-19, Cancer, Oncology, Global




Insights+ Exclusive: COVID-19 Healthcare News Monthly Updates – July 2020

Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it. The COVID-19 virus has been named “SARS-CoV-2” (severe acute respiratory syndrome coronavirus 2) and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). The outbreak of the respiratory disease was first detected in Wuhan City, Hubei Province, China in Dec 2019. Life sciences companies are putting all of their efforts into finding a treatment or developing a vaccine for this disease. PharmaShots is keeping a track of all of the important updates in the Life-sciences sector, where we have covered news updates regarding collaborations, clinical trials, funding, and regulatory guidelines related to the COVID-19 from Jan to date.

75. Roche’s Actemra/RoActemra (tocilizumab) Fails to Meet the Primary Endpoint in P-III COVACTA Study for Patients with COVID-19 Associated Pneumonia

Jul 30, 2020 | Clinical Trial

74. Sanofi and GSK Sign an Agreement with the UK Government to Supply ~60M Doses of COVID-19 Vaccine

Jul 29, 2020 | Collaboration

73. UK’s Recovery Continues to Test Roche’s Tocilizumab in COVID-19

Jul 29, 2020 | Clinical Trial

72. Roche’s Actemra/RoActemra Fails in COVID-19 Trial

Jul 29, 2020 | Clinical Trial

71. Green Cross’ GC5131A Receives the Regulatory Approval for P-II Trial for COVID-19

Jul 29, 2020 | Regulatory

70. Relief’s RLF-100 (aviptadil) Receives the US FDA’s Expanded Access Protocol to Treat Respiratory Failure in COVID-19

Jul 29, 2020 | Regulatory

69. AstraZeneca Signs an Agreement with Emergent BioSolutions to Expand Manufacturing of AZD1222 for COVID-19  

Jul 28, 2020 | Regulatory

68. Pfizer and BioNTech Initiate P-II/III Global Study of its Lead mRNA Vaccine Candidate Against COVID-19

Jul 28, 2020 | Clinical Trial

67. Gilead’s Veklury (Remdesivir) Health Canada’s Marketing Authorization with Conditions (NOC/c) to Treat COVID-19 

Jul 28, 2020 | Regulatory

66. Three Pharma Companies Launch Favipiravir to Treat COVID-19 in India  

Jul 27, 2020 | Launch

65. Sorrento to Acquire SmartPharm and Develop Pipeline of Gene-Encoded Therapeutic Antibodies Targeting COVID-19 and Cancer  

Jul 27, 2020 | Collaboration

64. AI Therapeutics Reports Initiation of P-II Trial of LAM-002A (apilimod dimesylate) for COVID-19 Patients

Jul 27, 2020 | Clinical Trial

63. Zydus to Initiate Clinical Study of Desidustat in Patients with Chemotherapy-Induced Anemia (CIA)  

July 24, 2020 | Clinical Trial

62. Glenmark Report Results of FabiFlu (favipiravir) in P-III Clinical Study for Patients with Mild to Moderate COVID-19

Jul 27, 2020 | Clinical Trial

61. The UK Government to Launch AbC-19 Lateral Flow Free Finger-Prick Test for COVID-19  

Jul 27, 2020 | Launch

60. Mylan Launches Remdesivir Under the Brand Name Desrem for COVID-19 in India  

Jul 27, 2020 | Launch

59. Pfizer and BioNTech Elicits Strong T-cell Response in P-I/II Study Against COVID-19

Jul 27, 2020 | Clinical Trial

58. AstraZeneca and Oxford University’s AZD1222 Delivers Dual Immune Response in its P-II/III COV001 Study Against COVID-19

Jul 27, 2020 | Clinical Trial

57. Quest Diagnostic Receives the US FDA’s First EUA for Sample Pooling in COVID-19  

Jul 20, 2020 | Diagnostic

56. Celltrion Initiates P-I Study of its COVID-19 Antibody Treatment in South Korea

Jul 20, 2020 | Clinical Trial

55. Zydus Initiates Adaptive P-I/II Clinical Study Evaluating its ZyCoV-D Against COVID-19 in India  

Jul 16, 2020 | Clinical Trial

54. Novartis Launches Zero Profit Portfolio for Symptomatic Treatment of COVID-19

Jul 16, 2020 | Launch

53. AstraZeneca and the University of Oxford to Share Positive News on its COVID-19 Vaccine Imminently

Jul 15, 2020 | Collaboration

52. 3M Collaborates with MIT to Develop Paper-Based Diagnostic Test for COVID-19

Jul 13, 2020 | Collaboration

51. Moderna to Commence Late-stage COVID-19 Vaccine Trial on 27 July, 2020

Jul 13, 2020 | Clinical Trial

50. The International Fencing Federation (FIE) Reports the Global COVID-19 Support Plan

July 13, 2020 | Launch

49. Gilead’s Veklury (remdesivir) Receives the TGA’s Approval to Treat Adults and Adolescents with Severe COVID-19 Symptoms  

Jul 12, 2020 | Regulatory

48. The Zimbabwe Government to Launch US $10M COVID-19 Relief Package

Jul 11, 2020 | Launch

47. Gilead’s Veklury (remdesivir) Receives the TGA’s Approval to Treat Adults and Adolescents with Severe COVID-19 Symptoms

Jul 10, 2020 | Regulatory

46. AstraZeneca Collaborates with ProteinQure to Design Novel Peptide Therapeutics

Jul 10, 2020 | Collaboration

45. Cipla Launches Cipremi at $53.34 per Vial in India

Jul 10, 2020 | Launch

44. The Health Ministry of Kyrgyzstan Reports Supply of Avifavir an Antiviral Drug form Russia

Jul 09, 2020 | Regulatory

43. Regeneron Signs an Agreement with BARDA and the US Department of Defense for REGN-COV2 Worth $450M

Jul 08, 2020 | Clinical Trial

42. Angion Commences P-II Study of ANG-3777 in Patients with Acute Lung Injury Associated with COVID-19 Pneumonia in Brazil

Jul 08, 2020 | Clinical Trial

41. The European Commission Signs an Agreement with Roche and Merck to Supply their COVID-19 Therapies in EU

Jul 09, 2020 | Collaboration

40. GSK and Medicago to Initiate P-I Trial of Plant-Based COVID-19 Vaccine in July 2020

Jul 08, 2020 | Clinical Trial

39. Regeneron Signs an Agreement with BARDA and the US Department of Defense for REGN-COV2 Worth $450M

Jul 08, 2020 | Collaboration  

38. Innovation Pharmaceuticals Reports Results Brilacidin in COVID-19 Clinical Trial

 Jul 07, 2020 | Clinical Trial

37. Reven Reports Publication of Two COVID-19 Articles for RJX Platform

Jul 07, 2020 | Regulatory

36. Emergent Signs a Five-Year Manufacturing Services Agreement with Janssen for Ad26.COV2-S to Treat COVID-19  

Jul 07, 2020 | Collaboration   

35. Constant Therapeutics’ TXA127 will be Evaluated in P-II Trial for COVID-19 Patients

Jul 07, 2020 | Clinical Trial

34. Sinovac’s P-III COVID-19 Trial Receives the Brazilian Regulator Approval  

Jul 07, 2020 | Regulatory

33. Nasus Pharma Reports Results of TaffiX as a Intranasal Antiviral Protection Against SARS-CoV-2

Jul 07, 2020 | Clinical Trial

32. Mylan Receives EUA Approval for its Remdesivir to Treat COVID-19  

Jul 07, 2020 | Regulatory

31. Diffusion Pharmaceuticals Reports IND Submission for P-Ib/IIb COVID-19 Clinical Program with TSC to the US FDA

Jul 07, 2020 | Clinical Trial

30. Novavax to Receive $1.6B Funds from the US

Jul 07, 2020 | Grants

29. Aboundbio Signs an Agreement with SaudiVax for COVID-19

Jul 07, 2020 | Collaboration

28. Hepion Pharmaceuticals Reports Preclinical Results of CRV431 for Treating COVID-19

Jul 07, 2020 | Clinical Trial

27. Therapeutic Solution Reports Submission of Publication of Preclinical Data on StemVac for Supporting COVID-19 Indication

 Jul 07, 2020 | Clinical Trial

26. Regeneron with its Partner NIAID Report the Initiation of P-III Trial to Evaluate REGN-COV2 for Treatment and Prevention of COVID-19  

Jul 06, 2020 | Clinical Trial

25. Mylan’s Remdesivir Lyophilized Powder for Injection Receives the DCGI Accelerated Approval for Restricted Emergency Use in COVID-19 Patients in India    

Jul 06, 2020 | Regulatory

24. Zydus to Initiate Clinical Trials Evaluating ZyCoV-D Vaccine Against COVID-19 in July 2020

Jul 03, 2020 | Clinical Trial

23. Sanofi and Regeneron’s Kevzara (sarilumab) Fails in P-III Trial for Patients with COVID-19 in the US

Jul 03, 2020 | Clinical Trial

22. Moderna Reports the Enrollment of P-II Trial for its mRNA-1273 to Treat COVID-19  

Jul 03, 2020 | Clinical Trial

21. Sorrento Selects T-VIVA-19 as a Targeted Protein Vaccine Candidate Against COVID-19

Jul 02, 2020 | Clinical Trial

20. Dr. Reddy’s and GRA Collaborate with Fujifilm for Avigan (favipiravir) to Treat COVID-19 Outside Japan

Jul 02, 2020 | Collaboration

19. Pfizer and BioNTech Report Results of BNT162b1 mRNA-Based Vaccine in P-I/II Study Against COVID-19

Jul 02, 2020 | Clinical Trial

18. Zydus to Initiate Clinical Trials Evaluating ZyCoV-D Vaccine Against COVID-19 in July 2020

Jul 03, 2020 | Clinical Trial

17. Sanofi and Regeneron’s Kevzara (sarilumab) Fails in P-III Study for Patients with COVID-19 in the US

Jul 02, 2020 | Clinical Trial

16.  Phase II Study of MRx-4DP0004 in Patients Hospitalized with COVID-19 Open for Enrolment

Jul 02, 2020 | Clinical Trial

15.  Regulatory Authorities Step Up Cooperation in Connection with COVID-19

Jul 02, 2020 | Regulatory

14. Austria Donates €2M to CEPI to Support COVID-19 Vaccine Programmes

Jul 02, 2020 | Grant

13. Liminal BioSciences Joins CoVIg Plasma Alliance to Develop New COVID-19 Therapy

Jul 02, 2020 | Collaboration

12. Biophytis Receives FDA IND Clearance for COVA, a P-II/III Clinical Trial with Sarconeos (BIO101) for the Treatment of Patients with COVID-19 Related Respiratory Failure

Jul 02, 2020 | Clinical Trial

11.  EUSA Receives the US FDA Approval of P-III Clinical Trial for Siltuximab in Hospitalized Patients With COVID-19 Associated Acute Respiratory Distress Syndrome

Jul 02, 2020 | Clinical Trial

10.  Moderna Faces Delay in its COVID-19 Vaccine Trial

Jul 02, 2020 | Clinical Trial

9. Anivive Initiates Two Pre-Clinical Studies of GC376 for the Treatment of COVID-19

Jul 02, 2020 | Clinical Trial

8. MediciNova Announces Opening of IND for MN-166 (ibudilast) for Prevention of Acute Respiratory Distress Syndrome in Patients with COVID-19

Jul 01, 2020 | Clinical Trial

7. GoldenBiotech’s Antroquinonol Receives FDA Approval on COVID-19 P-II Trial in the US

Jul 01, 2020 | Regulatory

6. New Study Highlights Senhwa Biosciences Silmitasertib as Potential Treatment for COVID-19

Jul 01, 2020 | Clinical Trial

5. International Regulators Provide Guiding Principles for COVID-19 Clinical Trials

Jul 01, 2020 | Regulatory

4.  FibroGenesis Identifies Mechanism Responsible for Blocking COVID19-Like Lung Inflammation

Jul 01, 2020 | Clinical Trial

3. Inimmune Awarded $2M SBIR to Advance Vaccine Technologies

Jul 01, 2020 | Grant

2. UNION Receives Danish Medicines Agency’s Approval to Initiate Clinical Study With Niclosamide for Treatment of COVID-19

Jul 01, 2020 | Clinical Trial

1. FAMHP Facilitates and Supports the Development of COVID-19 Treatments and Vaccines

Jul 01, 2020 | Regulatory

Related Post : Insights+ Exclusive: COVID-19 Healthcare News Monthly Updates – June 2020




Sangamo Signs a Worldwide License Agreement with Novartis to Develop Genomic Therapies for Three Neurodevelopmental Targets

Shots:

  • Sangamo to receive $75M upfront within 30 days, $720M milestone payments including up to $420M in development milestones and up to $300M in commercial milestones plus royalties on sales of the product. Additionally, Sangamo to take care of certain research and manufacturing activities funded by Novartis
  • Novartis to get exclusive license rights of ZFP-TFs for three genes including ASD and intellectual disability for neurodevelopmental disorders also holds an option to license Sangamo’s AAVs. The company will perform research activities, investigational new drug-enabling studies clinical development, related regulatory interactions, manufacturing and, global commercialization
  • ZFP-TFs is a genome regulation technology delivered using AAVs and will be utilized by the partnering companies to upregulate, or activate, the expression of genes expressed in individuals with certain types of neurodevelopmental disorders

Click here to read full press release/ article | Ref: Businesswire | Image: Healthworld




Novartis, company culture and COVID-19: the pharmaphorum podcast

Novartis’ Steven Baert joined the pharmaphorum podcast for episode 22 to discuss how COVID-19 will change the face of company culture, now and in the future.

We also looked at how Novartis’ own operations had to change in response to the coronavirus pandemic and the considerable challenges that presented him as its chief people and organisation officer.

It’s a role that sees him responsible for the physical and mental wellbeing of 130,000 employees around the world, huge numbers of which had to rapidly transition to new ways of remote working.

Steven also talked about how his company’s culture has already changed in response to COVID-19 and what he thinks the virus means for pharma’s future working practices.

You can listen to episode 22 of the pharmaphorum podcast here, download the episode to your computer or find it – and subscribe to the rest of the series in iTunes, Spotify, acast and Stitcher.

The post Novartis, company culture and COVID-19: the pharmaphorum podcast appeared first on .

PharmaShots Weekly Snapshot (Jul 20- 24, 2020)

 1.  Gilead and Galapagos’ Jyseleca (filgotinib) Receive the CHMP’s Positive Opinion for Moderate to Severe Rheumatoid Arthritis 

Published: Jul 24, 2020 | Tags: Gilead, Galapagos, Jyseleca, filgotinib, Receive, CHMP, Positive Opinion,  Moderate, Severe, Rheumatoid Arthritis

2.  Synaffix Expands its Existing Collaboration with ADC Therapeutics to Explore Two Additional Programs

Published: Jul 24, 2020 | Tags: Synaffix, Expands, Existing Collaboration, ADC, Explore, Two Additional Programs

 3. Zydus to Initiate Clinical Study of Desidustat in Patients with Chemotherapy-Induced Anemia (CIA)

Published: Jul 23, 2020 | Tags: Zydus, Initiate, Clinical Study, Desidustat, Patients, Chemotherapy Induced Anemia, CIA

4. AstraZeneca’s Breztri Aerosphere Receives the US FDA’s Approval for the Maintenance Treatment of COPD

Published: Jul 24, 2020 | Tags: AstraZeneca, Breztri Aerosphere, Receives, US, FDA, Approval, Maintenance Treatment, COPD

5. Abbott’s IOS-Compatible App Receives the US FDA’s Approval for Patients with Neurological Disorder

Published: Jul 17, 2020 | Tags: Abbott, IOS-Compatible App, Receives, US, FDA, Approval, Patients, Neurological Disorder

6. BioMarin Reports the Submission of MAA to EMA for Vosoritide to Treat Children with Achondroplasia

Published: Jul 23, 2020 | Tags: BioMarin, Reports, Submission, MAA, EMA, Vosoritide, Treat, Children, Achondroplasia

7.  Ovid Therapeutics and University of Connecticut Collaborate to Accelerate the Development of OV101 (gaboxadol) for Angelman Syndrome

Published: Jul 22, 2020 | Tags: Ovid Therapeutics, University of Connecticut, Collaborate, Accelerate, Development, OV101, gaboxadol, Angelman Syndrome

8.  Genentech Reports Results of Port Delivery System with Ranibizumab in P-III Archway Study for Neovascular Age-Related Macular Degeneration

Published: Jul 22, 2020 | Tags: Genentech, Reports, Results, Port Delivery System, Ranibizumab, P-III, Archway Study, Neovascular Age-Related Macular Degeneration

9. Glenmark Report Results of FabiFlu (favipiravir) in P-III Clinical Study for Patients with Mild to Moderate COVID-19

Published: Jul 22, 2020 | Tags: Glenmark, Report, Results, FabiFlu, favipiravir, P-III, Clinical Study, Patients, Mild, Moderate, COVID-19

10. Daiichi Sankyo Signs a Research Agreement Gustave Roussy for DS-1062 and Patritumab Deruxtecan to Treat Lung and Breast Cancer

Published: Jul 23, 2020 | Tags: Daiichi Sankyo, Signs, Research Agreement, Gustave Roussy, DS-1062, Patritumab Deruxtecan, Treat, Lung, Breast Cancer

11. Chugai and Biofourmis Collaborate to Develop Solutions for Digitally Measuring Endometriosis Pain

Published: Jul 23, 2020 | Tags: Chugai, Biofourmis, Collaborate, Develop, Solutions, Digitally Measuring, Endometriosis Pain

13.  AbbVie Reports Results of Rinvoq (upadacitinib) as Monotherapy in a P-III Measure Up 2 Study for Atopic Dermatitis

Published: Jul 22, 2020 | Tags: AbbVie, Reports, Results, Rinvoq, upadacitinib, Monotherapy, P-III, Measure Up 2, Study, Atopic Dermatitis

14.  Evotec Collaborates with Quantro Therapeutics to Discover and Develop Novel Therapies for Cancer and Other Diseases

Published: Jul 22, 2020 | Tags: Evotec, Collaborates, Quantro Therapeutics, Discover, Develop, Novel, Therapies, Cancer, Other Diseases

15Boston Scientific Receives the US FDA’s Approval for Next-Generation WATCHMAN FLX Left Atrial Appendage Closure Device

Published: Jul 20, 2020 | Tags: Boston Scientific, Receives, US, FDA, Approval, Next-Generation, WATCHMAN FLX, Left Atrial, Appendage Closure Device

16.   Gilead to Acquire Tizona’s Stakes for $300M

Published: Jul 22, 2020 | Tags: Gilead, Acquire, Tizona, Stake, $300M, AbbVie, TTX-080, TTX-03

17.  Biocon Collaborates with Voluntis on Digital Therapeutics for Insulins

Published: Jul 21, 2020 | Tags: Biocon, Collaborates, Voluntis, Digital Therapeutics, Insulins

18.  Paige Receives the US FDA’s 510(k) Clearance for its FullFocus Viewer to Use in Digital Pathology

Published: Jul 22, 2020 | Tags: Paige, Receives, US, FDA, 510(k), Clearance, FullFocus Viewer, Use, Digital Pathology

19.  The UK Government to Launch AbC-19 Lateral Flow Free Finger-Prick Test for COVID-19

Published: Jul 21, 2020 | Tags: The UK, Government, Launch, AbC-19, Lateral Flow, Free Finger-Prick Test, COVID-19

20.  Roche Collaborates with Jnana Therapeutics to Discover Novel Therapies to Treat Immune-Mediated and Neurological Diseases

Published: Jul 21, 2020 | Tags: Roche, Collaborates, Jnana Therapeutics, Discover, Novel Therapies, Treat, Immune-Mediated, Neurological Diseases

21.   Mylan Launches Remdesivir Under the Brand Name Desrem for COVID-19 in India

Published: Jul 20, 2020 | Tags: Mylan, Launches, Remdesivir, Under, Brand Name, Desrem, COVID-19, India

22.  Pfizer and BioNTech Elicits Strong T-cell Response in P-I/II Study Against COVID-19

Published: Jul 21, 2020 | Tags: Pfizer, BioNTech, Elicits, Strong, T-cell, Response, P-I/II, Study, Against, COVID-19, Germany

23. AstraZeneca and Oxford University’s AZD1222 Delivers Dual Immune Response in its P-II/III COV001 Study Against COVID-19

Published: Jul 20, 2020 | Tags: AstraZeneca, Oxford University, AZD1222, Delivers, Strong, Immune Response, P-II/III, COV001, Study, Against, COVID-19  

24.  Royalty Pharma Acquires PTC’s Royalty Interest in Risdiplam for $650M

Published: Jul 19, 2020 | Tags: Royalty Pharma, Acquires, PTC, Royalty Interest, Risdiplam,  $650M

25.  Quest Diagnostic Receives the US FDA’s First EUA for Sample Pooling in COVID-19

Published: Jul 19, 2020 | Tags:  Quest Diagnostic, Receives, US, FDA, First, EUA, Sample Pooling, COVID-19

26. Roche Signs RWD Collaboration with PicnicHealth to Create Personalized Treatment for Patients with Multiple Sclerosis

Published: Jul 19, 2020 | Tags: Roche, Signs, RWD, Collaboration, PicnicHealth, Create, Personalized Treatment, Patients, Multiple Sclerosis

27.   Celltrion Initiates P-I Study of its COVID-19 Antibody Treatment in South Korea

Published: Jul 19, 2020 | Tags: Celltrion, Initiates, P-I, Study, COVID-19, Antibody Treatment, South Korea

28.   GSK to Acquire 10% stake in CureVac for $163M

Published: Jul 20, 2020 | Tags: GSK, Acquire, 10%, Stake, CureVac, $163M




UCB’s IL-17 latecomer bimekizumab beats Cosentyx in psoriasis trial

Belgian biopharma company UCB is bringing up the rear of the IL-17 inhibitor category with its bimekizumab drug, so is celebrating new late-stage data showing superiority to the class leader.

The BE RADIANT trial pitted bimekizumab against Novartis’ Cosentyx (secukinumab) in the treatment of adults with moderate-to-severe psoriasis, and according to UCB is the first study to compare IL-17 drugs directly in this setting.

Bimekizumab performed better than Cosentyx across all the primary and secondary measures in the study, and according to analysts at Jefferies the trial “should facilitate UCB’s ability to carve a niche in the highly competitive psoriasis market.”

They think that could translate into peak sales of more than $2bn a year for UCB’s drug, up from their earlier estimate of $1.5 billion, assuming follow-up phase 3 trials in psoriatic arthritis and ankylosing spondylitis come good.

That would help ease the pain of the forthcoming patent expiries for the Belgian drugmaker’s current top-selling product Cimzia (certolizumab pegol), due in Europe in 2021 and in the US in 2024.

Cimzia accounted for €1.7 billion of the group’s 4.9 billion in sales last year, and bimekizumab has taken on even greater importance for the company after another pipeline drug – epilepsy candidate padsevonil – failed a clinical trial in March.

In BE RADIANT bimekizumab performed better than Cosentyx at achieving complete clearance of skin lesions – known as a PASI 100 response – at both 16 and 48 weeks. It also topped Novartis’ $3.6 billion blockbuster on the proportion of patients with a 75% improvement in skin lesions at four weeks.

That’s good news for UCB, but while it’s the first IL-17 drug that has shown superiority to Cosentyx in a head-to-head trial, other new biologics with blockbuster sales forecasts are also aiming to steal psoriasis market share from Novartis.

Just this week Eli Lilly reported that its IL-23 inhibitor mirikizumab outperformed Cosentyx in the OASIS trial, setting up regulatory filings later this year.

Meanwhile, AbbVie’s already-marketed IL-23 drug Skyrizi (risankizumab) also topped Novartis’s drug in testing and has got off to a swift start since its launch last year, with first-quarter 2020 sales of $300 million.

Jefferies notes that sales upside for bimekizumab are capped in a psoriasis market “dominated by competitors with large marketing budgets,” and suggests that UCB may now seek out a commercial partner to give it more marketing muscle.

The analysts are positive on UCB’s prospects overall, despite patent expires, with blockbuster sales also predicted for osteoporosis therapy Evenity (romosozumab) and zilucoplan for generalised myasthenia gravis.

The post UCB’s IL-17 latecomer bimekizumab beats Cosentyx in psoriasis trial appeared first on .

Novartis takes $485m hit after axing eczema drug from pipeline

Novartis has axed development of its mid-stage eczema drug ZPL389, taking a $485 million hit in the process.

Buried deep in the Swiss company’s Q2 results statement, the company said it had discontinued development of the oral H4 receptor antagonist.

Novartis added ZPL389, also known as adriforant, to its pipeline with a buyout of UK biotech Ziarco in late 2016.

At that time Sanofi was cruising towards an important FDA approval for its Dupixent (dupilumab) injection for the skin disease also known as atopic dermatitis.

Noting the blockbuster potential for drugs that treat the underlying cause of the inflammatory disease driven by the immune system, several other big pharma companies tried to get in on the act.

But three years after buying Ziarco for an undisclosed sum, Novartis said the phase 2 drug had been scrapped.

Novartis had been eyeing a potential filing with regulators in 2024 or later.

It’s perhaps not a surprise as the drug had missed an endpoint related to itch in a phase 2a study shortly before Novartis bought out Ziarco.

The drug had outperformed placebo at reducing eczema symptoms, which had been enough to convince Novartis that the project was worth investing in.

It’s the latest disappointment for Novartis and its bid to take on Dupixent, which has become one of Sanofi’s most important drugs with sales of 776 million euros ($880 million) in Q1 after approval in eczema and asthma.

Novartis paid $110 million for global rights for Galapagos and MorphoSys anti-IL-17C antibody MOR106 in 2018 – but the biotech axed development in October last year after an analysis midway through a phase 2 trial showed it was likely to fail.

Spain’s Almirall is another company hoping to take on Sanofi – it has licensed in lebrikizumab from Dermira.

Almirall is hoping that the IL-13 inhibitor class drug will be a strong competitor for Dupixent, which has a different mechanism of action focused on IL-4.

Incyte is also planning a US filing of its atopic dermatitis cream containing ruxolitinib before the end of this year.

The topical formulation of the JAK1/2 inhibitor hit targets in a pair of phase 3 trials that produced readouts earlier this year.

The post Novartis takes $485m hit after axing eczema drug from pipeline appeared first on .

Biogen plans trial of Spinraza in patients not responding to SMA gene therapy

Biogen is planning to trial its Spinraza spinal muscular atrophy (SMA) drug in patients who have not responded properly to Novartis’ gene therapy Zolgensma, combining the two ultra-expensive therapies to treat the rare muscle-wasting disease.

In the US, a single shot of Zolgensma (onasemnogene abeparvovec) costs $2.1 million, while Spinraza (nusinersen) costs $750,000 in its first year.

Biogen said it aims to begin a phase IV study as in a long-term follow-up study of Novartis’ drug it has been reported that some patients have been subsequently treated with Spinraza.

The phase IV RESPOND study aims to test efficacy and safety of Spinraza with a suboptimal clinical response to Zolgensma.

So far four out of 10 patients in a long-term study of Zolgensma have been subsequently treated with Spinraza, Biogen said.

Based on the planned study design, RESPOND will be a two-year, open-label study to evaluate the efficacy and safety of Spinraza in SMA patients previously treated with Zolgensma to further inform treatment decisions.

Efficacy will be assessed by change from baseline on motor function measures and additional clinical outcomes such as swallowing and caregiver burden.

Neurofilament levels, an exploratory endpoint, will also be evaluated as a marker of biological disease activity.

The primary study group aims to include 40 infants aged nine months or younger at the time of the first dose of Spinraza, who have two copies of SMN and are likely to develop type 1 disease and received Zolgensma at six months old or younger.

A second study group will include 20 children and will generate data in patients with a broader age range, up to three years old at the time of the first Spinraza dose.

After a screening period, participants will receive the approved 12 mg dose of Spinraza, which is four loading doses followed by maintenance doses every four months, over the two-year study period.

If approved by regulators the company aims to begin enroling patients in the first quarter of next year.

While Zolgensma is a gene therapy that aims to correct the genetic defect that causes the disease, Spinraza works by increasing the amount of full-length SMS protein that is critical to maintaining motor neurons.

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Biogen to launch Phase IV study of spinal muscular atrophy drug in post-gene therapy patients

The company plans to enroll 60 patients who have received its drug, Spinraza, following suboptimal response to Novartis’ Zolgensma, which was approved last year. The trial, RESPOND, is anticipated to start enrolling in the first quarter of 2021, pending regulatory approval.

Pandemic hits sales at Novartis after strong launch for SMA gene therapy

The COVID-19 pandemic has bit into sales at Novartis, the big Swiss pharma said in second quarter results, after orders fell back following a period of stockpiling earlier in the year.

Figures for the quarter showed reported sales fell by 4% to $11.3 billion compared with the corresponding period last year, although favourable currency fluctuations helped to soften the impact.

Net income was a reported $1.9 billion, down 11% compared with last year’s Q2.

The company said that COVID-19 negatively affected sales in April and May, mainly because of fewer patients starting courses of medicine and reducing visits to the doctor.

Novartis added that digital technology and new ways of working are helping to keep the company running smoothly and have reduced costs.

It has a digital clinical trial management system that has allowed trials to continue despite the disruption caused by the coronavirus outbreak.

The company said measures had “limited COVID-related impacts” to trial data filing timelines.

Results also showed a strong launch for its rare diseases gene therapy, Zolgensma, which is now approved for the muscle wasting disease spinal muscular atrophy (SMA) in the US and EU.

Zolgensma is a one-off shot that corrects the underlying genetic cause of the disease and is notable for being the world’s most expensive drug at $2.1 million.

Novartis’ AveXis unit only began launches of the drug in Europe this month, a few weeks after the drug hit the market in Japan.

But sales in the US are going well, where payers are clearly finding ways to deal with the drug’s price tag.

In Q2 Zolgensma generated revenues of $205 million, and for the half year they were $375 million.

Novartis’ psoriasis drug Cosentyx continues to gain traction with sales increasing by 10% to $944m in Q2, but sales of multiple sclerosis pill Gilenya fell in a competitive market, down by 11% to $738 million.

There is also a potential threat of generic competition to Gilenya, although Novartis said its forecasts assume that there will be no US generic approved this year.

The company said that guidance has “tightened” within previously announced ranges – net sales are expected to grow mid single digit, with core operating income expected to grow low double digit.

 

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Lilly’s mirikizumab tops Novartis’ blockbuster Cosentyx in psoriasis

Eli Lilly is a latecomer in the new generation of biologic therapies for psoriasis with its mirikizumab candidate, but a win in a head-to-head trial against Novartis’ big-selling Cosentyx could help close the gap.

The pivotal trial with anti-IL-23 antibody mirikizumab – OASIS-2 – delivered a significant improvement over placebo at 16 weeks, achieving its primary objective, but while that would help secure marketing approval it would not be enough to give Lilly a return on its investment.

More importantly, 12-month data from the trial showed that mirikizumab outperformed Novartis’ IL-17-targeting antibody Cosentyx (secukinumab), which brought in $3.6 billion in sales last year in psoriasis as well as other indications like psoriatic arthritis and ankylosing spondylitis.

The results mean Lilly can now submit mirikizumab to regulatory authorities around the world armed with data showing it works better than Cosentyx, which could help it grow more quickly in the crowded psoriasis market if it is eventually approved.

In OASIS-2, 74% of patients had a 90% improvement in psoriasis symptoms (PASI 90) at 16 weeks with mirikizumab – roughly the same proportion as those on Cosentyx, which compared to 6% of the placebo group.

At the 12-month timepoint there was no placebo assessment, with a monthly 300 mg dose of Cosentyx compared to 250 mg of mirikizumab given every four or eight weeks. For Lilly’s drug, PASI 90 scores were seen in upwards of 81% of patients, while for Cosentyx they had dipped below 70%.

A similar pattern was seen in patients who had complete clearance of their skin lesions (PASI 100), at around 37% for the two active drugs versus 1.8% for placebo at four months. After a year, that outcome was seen in 43% of the Cosentyx group, and 54% and 59% for the four- and eight-week mirikizumab doses.

“We look forward to bringing mirikizumab to market to provide patients with an additional treatment option that has the potential to provide near complete or complete skin clearance as measured by PASI 90 and PASI 100, with sustained results at 52 weeks,” commented Patrik Jonsson, president of Lilly Bio-Medicines.

Mindful of its latecomer status, Lilly is investing heavily to catch up with Cosentyx and other new psoriasis antibodies, including IL-23-targeting drugs like AbbVie’s Skyrizi (risankizumab) – which also trumped Cosentyx in a head-to-head trial – as well as Johnson & Johnson’s Tremfya (guselkumab) and Sun Pharma’s Ilumya (tildrakizumab).

Lilly is also running large-scale phase 3 trials of mirikizumab in ulcerative colitis and Crohn’s disease to expand the potential uses of the antibody in an attempt to build a franchise quickly.

Skyrizi is thought by some analysts to be the key rival in psoriasis. AbbVie’s only launched last year but is already on track for blockbuster sales with a turnover of $300 million in the first quarter of 2020, notwithstanding the possible brake on sales caused by coronavirus lockdowns.