Category: Boehringer Ingelheim

• This year J.P. Morgan 39^th Annual Healthcare Conference was conducted virtually and we witnessed multiple announcements from numerous Biopharma companies
• An analysis of events and catalysts that were announced at the conference during these days are included in the report. Most of the deals occurred in the first two days of the conference
• Our PharmaShots team summarized the key deals which took place during the conference from Jan 11 to Jan 14, 2020

Day 1

Bluebird bio to Spin-Off its Oncology Business into Independent Company

• Bluebird bio spun off its genetic disease and oncology business into a new company
• The company will retain focus on SGD and will launch its oncology business (“Oncology Newco”) as a new entity
• Current CEO, Nick Leschly will assume as the CEO of the new company and the anticipated completion date is Q4’21

Sanofi to Acquire Kymab for ~$1.45B

• Sanofi to acquire Kymab for $1.1B up front and ~$350M following the achievement of certain milestones. The transaction is expected to be completed in H1’21
• The acquisition will add KY1005 to Sanofi’s pipeline and will expedite its presence in the field of immunology
• Sanofi will receive the global rights of KY1005 which is a mAb targeting OX40-ligand, currently being evaluated in early P-I/II study as monothx. and in combination with an anti-PD-L1 for immune-mediated diseases and inflammatory disorders

BeiGene Signed a Development and Commercialization Agreement with Novartis

• BeiGene will receive $650M up front and is eligible to receive up to $1.3B in development and regulatory milestones and up to $250M in sales milestones, plus royalties
• BeiGene granted Novartis exclusive rights to develop and commercialize tislelizumab for the treatment of cancer in the United States, Canada, Mexico, the European Union, United Kingdom, Norway, Switzerland, Iceland, Liechtenstein, Russia, and Japan
• BeiGene will be responsible for ongoing clinical study and Novartis will fund the new clinical studies. The partners will retain the right to commercialize its proprietary products in combination with tislelizumab
• Tislelizumab is an anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages

Illumina Signed a Research Pact with Bristol Myers Squibb

• Illumina signed a research partnership with Bristol Myers Squibb to develop a microsatellite instability CDx and liquid biopsy assay based on Illumina’s TruSight Oncology 500 ctDNA

Illumina Signed a Research Pact with Kura Oncology

• Illumina signed a research partnership with Kura Oncology to develop CDx for HRAS mutations in Head and Neck Squamous Cell Carcinomas (HNSCC)

Myriad Genetics Signed a Development and Commercialization Agreement with Illumina

• Myriad Genetics granted Illumina an exclusive right to develop and commercialize kits for the assessment of HRD by combining TruSight Oncology content and Myriad’s myChoice CDx test

Illumina Signed a Clinical Trial Agreement with Merck

• Illumina collaborates with Merck to evaluate TruSight Oncology 500 for HRD offering

Boehringer Ingelheim Signed a Research Pact with Google

• Boehringer Ingelheim signed a research partnership with Google to develop therapies by applying Boehringer’s expertise in computer-aided drug design and in-silico modeling with Google’s quantum computers and algorithms. T
• The research was conducted in Boehringer’s newly established Quantum Lab and the terms of the research are for three years

Broad Institute of MIT, Harvard, and Verily Signed a Contract Service Deal with Microsoft

• Broad Institute of MIT, Harvard, and Verily signed a contract service deal with Microsoft to accelerate innovations in biomedicine through the Terra platform

Apple Signed a Research Pact with Biogen

• Apple signed a research partnership with Biogen to identify digital biomarkers that can serve as early indicators of cognitive illnesses like Alzheimer

Komodo Health to Acquire Mavens

• The acquisition strengthens Komodo’s Healthcare Map and software suite with the integration of Mavens’ Cloud-based Platform with a Suite of Software

Day 2

Enara Bio Signed a Research Pact with Boehringer Ingelheim

• Enara Bio collaborates with Boehringer Ingelheim to develop TCR-directed immunotherapies and therapeutic vaccines by combining Enara Bio’s dark antigen platform technology and expertise in cancer antigen identification and Boehringer’s immune-oncology platforms, including oncolytic viruses and cancer vaccines
• Enara Bio will lead the discovery and validation of dark antigens. Boehringer Ingelheim will get an exclusive option to license 3 dark antigens for lung and gastrointestinal cancers and will be responsible for preclinical, clinical development, and commercialization
• Enara Bio retain the rights to cell therapy-based products and will receive an up front and option fee and is eligible for research & preclinical milestones per target and up to $1.06B in clinical, regulatory, and sales milestones, plus royalties

Gilead Signed a Clinical Trial Agreement with Vir Biotechnology

• The companies collaborated to evaluate Gilead’s TLR-8 agonist, selgantolimod in combination with Vir’s siRNA VIR-2218 for the treatment of chronic hepatitis B virus infection
• The partners planned to conduct P-II multi-arm study
• The participants in the study will also receive Gilead’s Vemlidy. The partners will own their proprietary drug

Biond Biologics Signed a Development and Commercialization Deal with Sanofi

• Biond Biologics granted Sanofi exclusive, worldwide rights to develop and commercialize BND-22 for the treatment of solid tumors
• Biond will lead the P-Ia development of BND-22 as monotherapy and in combination with other agents while Sanofi will be responsible for all further development and commercialization
• Biond Biologics will receive $125M up front and is eligible to receive ‘more than’ $1B in milestone payments, plus royalties

Steris to Acquire Cantel for $4.6B

• Cantel to receive $16.93 in cash and 0.33787 shares of Steris, valued at ~$84.66 with an enterprise value of $4.6B including $3.6B in equity and $1B in Cantel’s net debt and convertible notes
• The acquisition strengthens Steris’ infectious disease business with the addition of endoscopy and dental solution

Related Post: Insights+: Key Deals Updates of JP Morgan Healthcare Conference 2020

The post Insights+: Key Deals of JP Morgan Healthcare Conference 2021 first appeared on PharmaShots.

Takeda’s Alunbrig (brigatinib) Receives MHLW’s Approval as a 1L and 2L Treatment for ALK+ Advanced or Recurrent NSCLC

Published: Jan 22, 2020 | Tags: Takeda, Alunbrig, (brigatinib), Receives, MHLW, Approval,1L and 2L, Treatment, ALK+ Advanced or Recurrent NSCLC

MTPA and Aquestive Sign a License and Supply Agreement for Exservan (riluzole) to Treat ALS in the US

Published: Jan 22, 2020 | Tags: MTPA, Aquestive ,Sign ,License ,Supply Agreement, Exservan (riluzole) ,Treat, ALS ,US

ViiV’s Cabenuva (cabotegravir and rilpivirine) Receives the US FDA’s Approval as the First and Only Complete Long-Acting Regimen for HIV treatment

Published: Jan 22, 2020 | Tags: ViiV ,Cabenuva (cabotegravir and rilpivirine), Receives ,US, FDA Approval, First and Only Complete, Long-Acting ,Regimen, HIV, treatment

Eli Lilly Reports Results of Bamlanivimab (LY-CoV555) in P-III BLAZE-2 Study for Preventing COVID-19 at Nursing Homes

Published: Jan 22, 2020 | Tags: Eli Lilly, Reports, Results, Bamlanivimab (LY-CoV555), P-III, BLAZE-2 Study, Preventing, COVID-19, Nursing Homes

Servier and MiNA Therapeutics Collaborate to Develop saRNA Therapies for Neurological Diseases

Published: Jan 22, 2020 | Tags: Servier , MiNA Therapeutics, Collaborate ,Develop ,saRNA Therapies ,Neurological Diseases

Boston Scientific to Acquire Preventice for ~$1.2B

Published: Jan 22, 2020 | Tags: Boston, Scientific, Acquire, Preventice ,~$1.2B

Roche Reports the US FDA’s Acceptance of sNDA and Granted Priority Review for Esbriet (pirfenidone) to Treat UILD

Published: Jan 21, 2020 | Tags: Roche, Reports, US, FDA, Acceptance ,sNDA ,Granted ,Priority Review ,Esbriet (pirfenidone),Treat ,UILD

Qiagen’s PCR Tests Demonstrate Effectiveness in Detecting Mutations in SARS-CoV-2 Virus

Published: Jan 21, 2020 | Tags: Qiagen’s, PCR Tests, Demonstrate ,Effectiveness ,Detecting Mutations ,SARS-CoV-2 Virus

Haemonetics to Acquire Cardiva Medical for ~$510M

Published: Jan 21, 2020 | Tags: Haemonetics, Acquire ,Cardiva Medical,  ~$510M

Bayer and Merck’s Verquvo (vericiguat) Receives the US FDA’s Approval to Treat Chronic Heart Failure

Published: Jan 21, 2020 | Tags: Bayer, Merck, Verquvo (vericiguat) ,Receives ,US ,FDA, Approval, Treat, Chronic Heart Failure

MacroGenics’ Margenza (margetuximab-cmkb) Receives the US FDA’s Patients with Pretreated Metastatic HER2-Positive Breast

Published: Jan 21, 2020 | Tags: MacroGenics, Margenza (margetuximab-cmkb), Receives, US, FDA, Pretreated, Metastatic HER2-Positive Breast

Urovant’s Gemtesa (Vibegron) Receives the US FDA’s Approval for Overactive Bladder 

Published: Jan 21, 2020 | Tags: Urovant, Gemtesa (Vibegron) ,Receives, US, FDA, Approval, Overactive Bladder

Merck KGaA and GSK’s Bintrafusp Alfa Fails to Meet its Co-Primary Endpoints in Lung Cancer Study

Published: Jan 21, 2020 | Tags: Merck KGaA, GSK, Bintrafusp Alfa, Fails, Meet, Co-Primary Endpoints, Lung Cancer, Study

Vanda’s Hetlioz (tasimelteon) Receives the US FDA’s Approval for Nighttime Sleep Disturbances in Smith-Magenis Syndrome

Published: Jan 21, 2020 | Tags: Vanda,Hetlioz (tasimelteon) ,Receives, US, FDA, Approval, Nighttime Sleep Disturbances ,Smith-Magenis Syndrome

Ridgeback’s Ebanga (mAb114) Receives the US FDA’s Approval for the Treatment of Ebola

Published: Jan 21, 2020 | Tags: Ridgeback, Ebanga (mAb114), Receives, US, FDA, Approval , Treatment, Ebola

Sorrento Presents Preliminary Results of STI-2020 Against COVID-19

Published: Jan 20, 2020 | Tags: Sorrento, Presents, Preliminary, Results, STI-2020, COVID-19

Biohaven’s Troriluzole Fails to Meet its Co-Primary Endpoints in P-II/III Study for Alzheimer’s Disease

Published: Jan 20, 2020 | Tags: Biohaven, Troriluzole, Fails, Meet, Co-Primary Endpoints, P-II/III, Study, Alzheimer’s Disease

Daiichi Sankyo and AstraZeneca’s Enhertu (trastuzumab deruxtecan) Receives EU’s Approval for the HER2 Positive Metastatic Breast Cancer

Published: Jan 20, 2020 | Tags: Daiichi Sankyo, AstraZeneca, Enhertu (trastuzumab deruxtecan), Receives, EU, Approval, HER2 Positive, Metastatic Breast Cancer

Omeros Reports the US FDA’s Acceptance and Priority Review of BLA for Narsoplimab (OMS721) to Treat HSCT-TMA

Published: Jan 20, 2020 | Tags: Omeros, Reports, US, FDA, Acceptance ,Priority Review , BLA Narsoplimab (OMS721) ,Treat, HSCT-TMA

Thermo Fisher to Acquire Mesa Biotech for $450M

Published: Jan 20, 2020 | Tags: Thermo Fisher, Acquire, Mesa Biotech, $450M

Lilly and Merus Collaborate to Discover Novel T-Cell Re-Directing Bispecific Antibodies

Published: Jan 20, 2020 | Tags: Lilly, Merus ,Collaborate ,Discover, Novel T-Cell, Re-Directing, Bispecific Antibodies

Biocryst’s Orladeyo (berotralstat) Receives the US FDA’s Approval to Prevent Attacks of Hereditary Angioedema (HAE)

Published: Jan 20, 2020 | Tags: Biocryst, Orladeyo (berotralstat), Receives, US, FDA, Approval, Prevent ,Attacks, Hereditary Angioedema (HAE)

Myovant’s Orgovyx (relugolix) Receives the US FDA’s Approval as the First Oral GnRH Receptor Antagonist for Advanced Prostate Cancer

Published: Jan 20, 2020 | Tags: Myovant, Orgovyx (relugolix), Receives, US, FDA, Approval, First Oral, GnRH Receptor Antagonist, Advanced, Prostate Cancer

Philips to Acquire Capsule Technologies for ~$635M

Published: Jan 19, 2020 | Tags: Philips, Acquire, Capsule Technologies, ~$635M

Innovent Out Licenses Byvasda’s (biosimilar, bevacizumab) Development and Commercialization Rights to PT Etana in Indonesia

Published: Jan 19, 2020 | Tags: Innovent, Out Licenses, Byvasda’s (biosimilar, bevacizumab), Development, Commercialization Rights, PT Etana, Indonesia

Grifols to Evaluate New Immunoglobulin Therapy Against COVID-19 in Spain

Published: Jan 19, 2020 | Tags: Grifols, Evaluate, New Immunoglobulin Therapy, COVID-19, Spain

Janssen Signs a Research Agreement with TenNor to Develop Treatments for Nontuberculous Mycobacteria Diseases

Published: Jan 19, 2020 | Tags: Janssen, Signs, Research Agreement, TenNor, Develop, Treatments, Nontuberculous Mycobacteria Diseases

Tessa’s CD30 CAR-T Therapy Receives EMA’s PRIME Designation for Relapsed or Refractory Classical Hodgkin Lymphoma

Published: Jan 19, 2020 | Tags: Tessa, CD30 CAR-T Therapy, Receives, EMA, PRIME Designation, Relapsed or Refractory Classical Hodgkin Lymphoma

Boehringer Ingelheim Collaborates with Cure Genetics to Develop Next-Generation Liver-Targeted Gene Therapy

Published: Jan 19, 2020 | Tags: Boehringer Ingelheim, Collaborates, Genetics, Develop, Next-Generation, Liver-Targeted, Gene Therapy

Nanobiotix Presents Results of NBTXR3 (PEP503) in P-Ib/II Study for Rectal Cancer at ASCO-GI 2021

Published: Jan 18, 2020 | Tags: Nanobiotix, Presents, Results, NBTXR3 (PEP503), P-Ib/II , Study, Rectal Cancer, ASCO-GI 2021

Cardiff Oncology Report Results of Onvansertib in P- Ib/II Study for KRAS-Mutated Metastatic Colorectal Cancer

Published: Jan 18, 2020 | Tags: Cardiff Oncology, Report, Results, Onvansertib, P- Ib/II, Study, KRAS-Mutated, Metastatic, Colorectal Cancer

Genmab’s Darzalex Faspro (daratumumab and hyaluronidase-fihj) Receives the US FDA’s Approval for Patients with Newly Diagnosed Light-chain (AL) Amyloidosis

Published: Jan 18, 2020 | Tags: Genmab, Darzalex Faspro (daratumumab and hyaluronidase-fihj), Receives, US, FDA, Approval, Patients, Newly Diagnosed, Light-chain,(AL) Amyloidosis

Daiichi Sankyo and AstraZeneca’s Enhertu Receive the US FDA’s Approval for Previously Treated HER2-Positive Advanced Gastric Cancer

Published: Jan 18, 2020 | Tags: Daiichi Sankyo, AstraZeneca, Enhertu, Receive, US, FDA, Approval, Previously, Treated, HER2-Positive, Advanced, Gastric Cancer

AstraZeneca’s Imfinzi (durvalumab) New Dosing Option Receives Approval for NSCLC in the EU & UK

Published: Jan 18, 2020 | Tags: AstraZeneca, Imfinzi (durvalumab), New Dosing Option, Receives, Approval, NSCLC, EU, UK

GSK Presents Results of Dostarlimab in P-I GARNET Study for dMMR Solid Cancers at ASCO GI

Published: Jan 18, 2020 | Tags: GSK, Presents, Results, Dostarlimab, P-I, GARNET, Study,dMMR, Solid Cancers, ASCO GI

Related Post: PharmaShots Weekly Snapshots (Jan 11- 15, 2021)

The post PharmaShots Weekly Snapshots (Jan 18 – 22, 2021) first appeared on PharmaShots.

Shots:

• The companies collaborated to develop AAV vectors deploying Cure Genetics’ VELP platform to develop next-generation gene therapies
• The focus of the pact is to provide new AAV serotypes for patients. The collaboration integrates Boehringer Ingelheim’s experience in disease biology and gene therapy development with Cure Genetics’ AAV expertise in library construction and in vivo AAV screening
• The VELP technology provides effective solutions in increasing the efficiency of novel AAV screening, further expanding the efforts in the area of gene therapy development

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

The post Boehringer Ingelheim Collaborates with Cure Genetics to Develop Next-Generation Liver-Targeted Gene Therapy first appeared on PharmaShots.

• 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.

Boehringer Ingelheim has signed a strategic collaboration with UK biotech Enara Bio, focused on finding ways to fight cancer using “dark antigens” in a deal worth up to €876 million ($1.07bn).

Dark Antigens represent a new class of cancer-associated antigens that derive from the genomic “dark matter” – the portion of the human genome that is normally not expressed as protein.

These sequences are usually silenced in healthy cells but are activated and presented on tumour cells.

This makes them good targets for targeted therapies that will attack cancer cells while leaving healthy cells alone.

Dark antigens are associated with specific cancers and are shared across patients and since typically not visible to the immune system, they represent a large potential repertoire of novel antigens that can be developed as targets for new immunotherapies.

In the new collaboration, Boehringer wants to combine Enara’s expertise in antigen identification with its immune-oncology technology such as oncolytic viruses and cancer vaccines.

The discovery of shared antigens could lead to the development of vaccines that can be readily used to help a broader group of cancer patients.

Enara Bio’s proprietary technology will be used to discover and validate novel dark antigens in up to three tumour types in lung and gastrointestinal cancer.

Under the agreement, Boehringer Ingelheim has the option to license dark antigens discovered and validated by Enara Bio.

Boehringer will also be responsible for all non-clinical and clinical development, as well as marketing of associated cancer immunotherapies, including therapeutic vaccines and T-cell redirecting biologics.

Enara Bio retains rights to use any discovered antigens for use in cell therapy-based products.

Enara is eligible to receive an undisclosed upfront payment, together with research/preclinical milestones and licensing fees for each tumour type that is explored.

The Oxford-based biotech is also eligible to receive more than €876 million in clinical, regulatory and commercial milestones, in addition to royalties on future product sales.

Boehringer has been particularly active in cancer deal making, buying Swiss cancer biotech NBE-Therapeutics for €1.16bn ($1.43bn) in December, snapping up antibody-drug conjugate technology.

In the same week it bought cancer vaccine and oncolytic virus specialist Labor Dr. Merk & Kollegen.

The post Boehringer to investigate ‘dark antigens’ with UK cancer specialist Enara appeared first on .

Boehringer and Eli Lilly have moved closer to a heart failure indication for their SGLT2 inhibitor Jardiance, as the FDA starts a fast-track review of the drug in its first use beyond diabetes.

The US regulator is looking at data from the EMPEROR-Reduced trial of Jardiance (empagliflozin), which found that the drug achieved a 25% reduction in the combined primary endpoint of cardiovascular death or hospitalisation compared to placebo.

Lilly and Boehringer claim almost 60% market share for Jardiance among SGLT2 drugs used to treat type 2 diabetes, driving blockbuster sales for the brand.

It was the top-selling drug in the SGLT2 inhibitor class in 2019, with sales of almost $3 billion, helped by side-effect problems that have afflicted first-to-market rival Invokana (canagliflozin) from Johnson & Johnson.

However its rivals – which also include AstraZeneca’s Farxiga (dapagliflozin)  – have moved more swiftly into areas like heart failure and chronic kidney disease (CKD) which have made large numbers of new patients eligible for treatment with the class.

The new FDA review – covering Jardiance as a treatment for adults with heart failure with reduced ejection fraction (HFrEF) in patients with and without diabetes – is Lilly and Boehringer’s first chance to fight back.

Farxiga won FDA approval for adults with HFrEF in May 2020, which helped to drive its third-quarter sales up by a third to $525 million. AZ picked up EU approval for the same indication the following November.

Lilly and Boehringer will be hoping for a swift FDA review so that Jardiance will not fall too far behind its competitor in the heart failure category, and that looks likely as the benefit in HFrEF increasingly appears to be an SGLT2 class effect.

GlobalData has said that heart failure could add billions to the sales of the two SGLT2 inhibitors, particularly if they also claim approvals in heart failure with preserved ejection fraction (HFpEF), a larger patient population.

It says Farxiga will reach peak sales of $9 billion in 2028, with Jardiance forecast to reach $4.6 billion, assuming a launch for HFrEF this year. The bulk of those sales will come from HFpEF, however,  as in this form of heart failure there is a huge unmet need and no approved therapies.

Boehringer and Lilly are waiting for the results of the EMPEROR-Preserved later in 2021, while AZ should also Farxiga in the DELIVER trial in HFpEF, with additional data on both HFrEF and HFpEF due from the DETERMINE study, before year-end.

Meanwhile, EMPEROR-Reduced also showed a slowdown in the rate of decline in kidney function among patients with HFrEF, an effect that Lilly and Boehringer are exploring in the CKD patient population in the EMPA-KIDNEY trial due to generate results in 2022.

Invokana was the first mover among the SGLT2 drugs in the kidney area, winning FDA approval towards the end of 2019 for diabetic kidney disease. After a couple of years of declining sales due to concern about a risk of lower limb amputation, Invokana managed a 25% gain to $224 million in third-quarter 2020.

Farxiga meanwhile has already been filed for CKD on the back of the DAPA-CKD trial, with a verdict due in the second quarter.

The post Boehringer, Lilly’s Jardiance ties to match AZ’s Farxiga with heart failure label appeared first on .

• 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.

“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.

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.

Shots:

• Boehringer Ingelheim to acquire all shares of NBE-Therapeutics for ~$1.434B which include contingent clinical and regulatory milestones. The transaction is expected to be closed in Q1’21
• The acquisition will add NBE-Therapeutics’ ROR1-directed ADCs including NBE-002 which is currently in P-I studies for TNBC and other solid tumors
• NBE-Therapeutics’ iADC platform will add exceptional tumor-targeting capabilities to Boehringer Ingelheim’s oncology portfolio. The deal comes one month after Merck’s $2.8B acquisition of VelosBio for its anti-ROR1 ADC

Click here ­to­ read full press release/ article | Ref: Boehringer Ingelheim | Image: Business Wire

The post Boehringer Ingelheim to Acquires NBE-Therapeutics ~ .5B first appeared on PharmaShots.

Boehringer Ingelheim has expanded its oncology focus for the second time this week by buying Swiss biotech NBE-Therapeutics, adding an antibody-drug conjugate (ADC) platform led by a drug for a hard-to-treat form of breast cancer.

The German pharma group is paying €1.18 billion ($1.43bn) for all the shares in privately-held NBE, based in Basel, and says the biotech will remain at its current location and operate as a new site within its R&D network.

Terms of the deal haven’t been disclosed, but some of the headline value is tied to clinical and regulatory milestones.

NBE’s lead therapeutic NBE-002is in phase 1 testing for triple-negative breast cancer (TNBC), so called because it lacks the biomarkers that other targeted therapies can latch on to. TNBC is more aggressive than other types of breast cancer, accounting for 15-20% of cases but causing 25% of deaths.

All the Swiss company’s other development programmes are currently at the preclinical stage.

Boehringer started its push into oncology in the mid-2000s, and initially focused on small-molecule, targeted therapies for lung and gastrointestinal cancer, leading to commercial products like Giotrif (afatinib) and Vargatef (nintedanib).

In the last few years it has been progressively adding to its capabilities, for example buying oncolytic virus specialist ViraTherapeutics in 2018 and cancer vaccine player AMAL Therapeutics last year.

It also added antibody firm Northern Biologics earlier in 2020, and – just this week – immuno-oncology company Labor Dr. Merk & Kollegen, which specialises in cancer vaccines and oncolytic viruses.

NBE represents its first foray into the ADC category, which consists of antibodies targeting tumour-associated molecules that are linked to a cell-killing payload.

While they have been around for a couple of decades, the number of ADCs on the market remains low, but latterly the class has been gathering momentum in biopharma drug development as early issues with stability and toxicity have been ironed out.

Just this year, the FDA approved the first ADC for TNBC – Immunomedics’ Trodelvy (sacituzumab govitecan) – although that targets a different molecular target than NBE’s candidate. Trodelvy is directed against Trop2, while NBE-002 targets ROR1, which along with TNBC is also seen in lung adenocarcinomas.

Boehringer’s head of innovation Michael Pairet said that NBE provides the drugmaker with “exceptional” tumour-targeting capabilities that sits well alongside its own immune cell-targeting platforms.

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Healthy animals contribute to the elimination of hunger and sustainable food production. The diseases that affect animal health also affect humans. Tackling them while they are present in animals not only safeguards our health, but it is also easier, more effective, and less expensive to address. Monitoring animal health and preventing animal disease outbreaks is vital to the economy and safety of the food supply. Production of healthy livestock helps to ensure a safe food supply and keep consumer prices stable. In the top 20 ledgers, Zoetis ensured the top position with total revenue of $6.26B. Our team at PharmaShots has compiled the report of the top 20 Animal Health companies based on the 2019 animal health revenue.

KRKA is an international generic pharmaceutical company. The Company produces prescription and over-the-counter drugs for the treatment of cardiovascular, gastrointestinal, infectious, central nervous system, blood, respiratory tract, musculoskeletal, urogenital, and dermatological diseases. Krka’s modern animal health products provide effective and simple management of the most important bacterial infections, parasitic diseases, and pain control.

Animalcare Group is an international veterinary sales and marketing organization operating in seven countries and exports to approximately 32 countries in Europe and a further 16 worldwide. The Group develops and supplies veterinary pharmaceutical products and services to support the veterinary profession.

Orion is a globally operating Finnish pharmaceutical company that develops, manufactures, and markets human and veterinary pharmaceuticals and active pharmaceutical ingredients. The newest addition to Orion’s proprietary products is the prescription medicine Sileo (dexmedetomidine) oromucosal gel for dogs suffering from acute noise anxiety.

Eco Animal Health Group PLC is a United Kingdom-based engaged in the manufacture and marketing of animal health products. The company’s product portfolio includes Aivlosin – macrolide antibiotic for the treatment of respiratory and enteric diseases in pigs and poultry; Ecomectin, Ecoheart, Ecotraz, and Ecomintic for treatment and prevention of parasites in cattle, sheep, pigs, horses, and dogs and Chlortetracycline and Oxytetracycline for treatment of bacterial infections in pigs.

Heska was created by veterinary professionals for veterinary professionals dedicated to perfecting and supporting the core technology and services that truly impact the quality of pet care and help to ensure positive outcomes for veterinarians and their patients. Heska provides state-of-the-art chemistry, hematology, and blood gas & electrolyte systems, single-step heartworm, early renal health screens, allergy testing, and allergy treatment.

Ouro Fino Saude Animal is engaged in the production and sale of veterinary drugs, vaccines, and other products for cattle, pigs, poultry, sheep, horses, goats, and pets. The company’s reportable segments are Production animals, Companion animals, and International operations. It generates maximum revenue from the Production animals segment. The product portfolio includes Anticoccidians, Antimicrobials, Biological, Ectoparasiticides, Endectocides, Fortifiers / Supplements, and others.

Sequent Scientific Ltd is an India-based integrated pharmaceutical company operating an animal and a human health division. The Company operates in three segments which include active pharmaceutical ingredients (API), Analytical Services, and Animal Health. The Company’s APIs in animal health include Albendazole, Buparavaquone, Butaphosphan and Nitroscanate, and others.

Neogen develops and markets products and services dedicated to food and animal safety. The company’s diagnostic products are used by food and animal producers to test for foodborne bacteria, food allergen, natural toxins, drug, and chemical residues, plant diseases, and quality assurance.

Vetoquinol is a veterinary pharmaceutical laboratory that develops, manufactures, and markets veterinary drugs and non-medicinal products and services in Europe, North America, and Asia-Pacific. With a presence in 24 countries through its subsidiaries, its strong network of 100 distributor partners provides visibility for its products in more than 80 countries.

Kyoritsu Seiyaku Corporation manufactures drugs for animals. It develops, manufactures, and distributes various drugs for animals, pet care products, veterinary diet, and pet food, as well as provides veterinary services. Kyoritsu Seiyaku also offers human pharmaceuticals such as infertility and osteoporosis treatment drugs.

Dechra Pharmaceuticals is an international pharmaceutical business focused on the veterinary market, with its key area of specialization being the development and marketing of companion animal products. The Company is engaged in the development, manufacturing, and marketing of products for veterinarians.

Phibro Animal Health is an animal health and mineral nutrition company. The Company offers antibacterials, anticoccidials, anthelmintics, vaccines, and nutritional products for the treatment of animals and serves personal care, industrial chemical, and chemical catalyst industries worldwide.

Virbac is a France-based veterinarian pharmaceutical company specialized in the development and production of vaccines and medicines for domestic animals and livestock. Its development is focused mainly on formulating drugs designed to prevent or cure certain animal diseases.

Bayer is a life science company, and its segments include Pharmaceuticals, Consumer Health, Crop Science, and Animal Health. Bayer’s Animal Health segment is engaged in the development, production, and marketing of prescription and nonprescription veterinary products. Bayer has completed the sale of its Animal Health business unit to Elanco in Aug 2020.

Idexx Laboratories provides diagnostic, detection, and information systems for veterinary, food, and water testing applications. The Company also operates an international network of veterinary reference laboratories and offers its products to customers worldwide.

Elanco is a global animal health company that develops, manufactures, and markets products for companion and food animals and serves clients worldwide. Elanco acquired Bayer AG’s animal health unit in a deal valued at $7.6B, creating one of the biggest stand-alone veterinary medicine companies in the world.

Covetrus is a global animal-health company that provides animal-health technology and services. The Company combines practice management software, prescription management, multi-channel client engagement services, and supply chain infrastructure to promote connectivity between veterinarians and their clients worldwide.

MSD Animal Health, a division of Merck provides services and technologies, to prevent, treat, and control diseases across all major farm and companion animal species. It consists of commercial offices in more than 50 countries and business operations in more than 150 markets and runs a global network of manufacturing and R&D facilities

Boehringer Ingelheim serves clients worldwide, researches, develops, and manufactures pharmaceutical products, as well as offers prescription medicines and consumer health care products for human and animal health. The Boehringer Ingelheim Animal Health business is a global leader in the animal health industry and a part of Boehringer Ingelheim.

Zoetis is a global leader in the discovery, development, manufacture, and commercialization of animal health medicines, vaccines, and diagnostic products with a focus on both livestock and companion animals. It commercializes products primarily across species, including livestock, such as cattle, swine, poultry, fish, and sheep; and companion animals comprising dogs, cats, and horses.

Related Post: Top 20 Immunology Companies Based 2019 Immunology Segment Revenue

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Boehringer Ingelheim and South Korea’s Bridge Therapeutics have decided to axe their collaboration over a potential new drug for idiopathic pulmonary fibrosis (IPF), BBT-877.

The German pharma had hoped the drug would be a successor to Ofev (nintedanib), which is one of its most important drugs and is approved for the potentially fatal lung-scarring disease.

Signed in July last year, Boehringer paid 45 million euros up front and the deal would have been worth up to 1.1 billion euros in milestone payments if trials had worked out plus royalties.

While the companies gave no further details about why the partnership came to an abrupt halt, the German pharma announced earlier this year that it was concerned about the drug’s potential toxicity. Bridge said that it still plans to continue developing BBT-977 to treat IPF.

At the time the agreement was signed, BBT-877 was in phase 1 development but shares in Korean biotech tanked in August when Boehringer announced that BBT-877 would need additional testing.

This delayed a phase 2 trial and at the time Bridge acknowledged it was possible that the German pharma would return rights.

Boehringer had wanted to conduct two further toxicity tests following results from preclinical trials.

Following the cancellation of the tie-up, Bridge will regain all rights to BBT-877, which is also in development for other fibrotic diseases.

CEO James Lee said: “After receiving and reviewing data and dossiers, we will closely work with regulatory authorities to clarify future development plans and necessary studies to initiate human trials in the future.”

BBT-877 was originally discovered by Korea’s LegoChem Biosciences and licensed to Bridge Biotherapeutics in 2017.

It works by inhibiting autotaxin, a protein discovered in the early 1990s that is an important enzyme for generating the lipid-signalling molecule, lysophosphatidic acid.

Founded in 2015, Bridge’s clinical pipeline includes BBT-401, a first-in-class Pellino-1 inhibitor for ulcerative colitis.

It is also developing BBT-176, a potent targeted cancer therapy for non–small cell lung cancer (NSCLC). Bridge is resident at Johnson & Johnson’s JLABS facility in Shanghai.

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Shots:

• 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

Click here ­to­ read full press release/ article | Ref: Boehringer Ingelheim | Image: Yicai Global

The post Boehringer Ingelheim Initiates P-II Study of BI 764198 for Patients with Severe Respiratory Illness from COVID-19 first appeared on PharmaShots.

Shots:

• The companies present the findings from a new exploratory sub-analysis of the P-III EMPEROR-Reduced study demonstrating that Jardiance (empagliflozin) reduced the risk of adverse CV by 25% and kidney events by 50% in adults with HFrEF with/out diabetes regardless of CKD status at ASN Week 2020
• In all patient cohorts participating in the EMPEROR-Reduced trial, the safety profile was like the well-established safety profile of Jardiance. In Mar’2020, the US FDA granted FT designation to the therapy for CKD based on its ongoing EMPA-KIDNEY study with its expected results in 2022
• In 2019, the US FDA granted FT designation to Jardiance for the reduction of the risk of CV death and hospitalization for heart failure in people with HF based on its EMPEROR program, which consists of two P-III studies EMPEROR-Reduced & EMPEROR-Preserved

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Dialysis Patient Citizens Education Center

The post Boehringer Ingelheim and Eli Lilly Report Results of Jardiance in Adults with HFrEF Regardless of Chronic Kidney Disease Status first appeared on PharmaShots.

Patients with heart failure often have a dismal prognosis as the condition usually worsens over time, but a new study aims to see if digital health technologies can improve their prospects.

The trial – run by Boehringer Ingelheim and Yale University – will test a smart bathroom scale device that has cardiac monitoring built in, as well as an app to help patients improve their diet and lose weight and a digital assistant designed to motivate them to actively manage their health.

The investigators hope the digital tools will encourage people with heart failure to make and adhere to changes in their lifestyle that will improve “patient outcomes, clinical efficiencies and…quality of life.”

If it works, the approach could have a significant impact on the care of people with heart failure, which is a massive problem worldwide. In the US alone there are six million people with failing hearts, leading to a million hospitalisations each year.

The 200-patient study will look at each of the three digital technologies separately, added to standard care for heart failure, and see how they perform compared to standard care alone over a six-month period.

The primary endpoint of the study is improvement in quality of life assessed by a scale known as the KCCQ survey, with secondary measures including the number of hospitalisations, treatment prescribing rates and mortality.

Crucially, given the ongoing pandemic, all the digital technologies can be used in the home, so there will be no need for anything more than the regular follow-ups in clinic for the enrolled subjects.

“Our digital health study…will move beyond evaluating if these tools work and establish if they actually help make patients’ lives better, which is how these technologies should be judged,” said Yale professor of medicine Perry Wilson, one of the study investigators.

“The health of heart failure patients can change quickly, and these tools can help healthcare providers intervene before serious complications lead to hospitalisations, alleviating our overburdened healthcare system,” he added.

Boehringer is already an investor in the smart scale – called Bodyport – as the pharma company led the start-up’s $11 million first-round financing in August. The device is designed to detect cardiac signals and biomarkers through a user’s feet, rather than relying on wearables.

The live coaching app, Noom, provides personalised diet and weight management advice and its developers have also previously partnered with Novo Nordisk on a programme designed to help people struggling with obesity.

Finally, the motivational tool – Conversa – is an automated conversational platform that its developers say uses artificial intelligence and behavioural science methodology to encourage patient engagement.

The tool is already being used by hundreds of hospitals in the US to help manage chronic care, acute discharge, perioperative, cancer treatment and COVID-19, according to the company.

“We launched this study with Yale to help identify how digital health technology may address some of the key pain points for adults with heart failure, like the need for more frequent communication with healthcare providers in between visits and coaching to help with the daily management of the condition,” said Christine Marsh, Boehringer’s senior vice president, market access.

Results from the study are due next year, according to the investigators.

Heart failure has become a hot topic for study of digital interventions, in part because of the slow progression of the condition also because adherence to treatment and lifestyle interventions is closely linked to how well patients fare.

Johnson & Johnson for example is deploying wearables and smartphone apps in the CHIEF-HF trial of its Invokana (canagliflozin) in heart failure patients.

Amgen meanwhile is sponsoring a study in the US to investigate whether wearables can help physicians monitor changes in heart failure patients’ conditions so they can get the optimal doses of medications.

The post Boehringer, Yale trial digital tech in heart failure appeared first on .

A fellowship programme is looking for digital pioneers to design and lead service transformation projects in England’s NHS as the COVID-19 pandemic continues.

DigitalHealth.London opens applications to its Digital Pioneer Fellowship programme, supporting change makers employed by NHS organisations in London to design and lead transformation projects underpinned by digital innovation.

Sponsored this year by Boehringer Ingelheim, the programme is now in its third year.

It provides up to 30 fellows with the opportunity to be part of a learning community focused on accelerating the pace of digital transformation within their respective NHS organisations.

Individuals taking part have access to workshops, resources and events throughout the year to share challenges and experience, learn from experts and collaborate to co-design solutions.

They will hear from and be given the opportunity to ask questions of sector experts during taught modules on subjects ranging from change management and business case development to agile delivery and service improvement.

Fellows will also be able to choose a mentor and be grouped into action learning sets with other fellows working in similar environments on digital transformation projects.

In the first year of the programme over 80% of the fellows surveyed cited positive gain, saying that they gained specific technical skills or had met an individual challenge thanks to the fellowship.

All fellows surveyed were confident that being part of the fellowship was of benefit to their career, DigitalHealth.London said in a statement.

Sara Nelson, programme lead, digital pioneer fellowship, said: “The COVID-19 pandemic has been one of the biggest challenges the NHS has faced and I have no doubt that the staff’s quick adaptation and uptake of digital innovations has been vital in enabling key services and care to continue over this period.

“As a nurse with over 25 years of service to the NHS, I appreciate how challenging digital transformation in the NHS can be if staff aren’t given the support, advice and time to develop professional skills that they need.

“I am extremely proud of the individuals we have supported previously through our Digital Pioneer Fellowship programme for the contributions they have made to bringing digital innovation into London’s NHS, and am very pleased today to announce the opening of applications for the next cohort of pioneers.”

 

 

 

 

The post NHS looks for digital pioneers to reshape services during pandemic appeared first on .

Shots:

• Boehringer Ingelheim has acquired Global Stem cell Technology (GST) focusing to strengthen its portfolio capabilities to accelerate innovation and growth
• The acquisition follows two years of partnership b/w the companies that brought the first-ever registered stem cell-based veterinary medicine (Arti-Cell Forte) in the EU
• The acquisition of GST will accelerate the development pipeline of Boehringer Ingelheim while maintaining its focus on setting new standards of care for animals. Arti-Cell Forte is testimony to the innovation strength that lies within both companies

Click here ­to­ read full press release/ article | Ref: Boehringer Ingelheim | Image: GST

Shares in Redx Pharma were soaring this morning after it licensed its preclinical fibrotic disease drug RXC006 to AstraZeneca.

The company’s shares were valued as high as 95p on the London Stock Exchange following the announcement, the highest they had been since 2015.

AstraZeneca has bought an exclusive global licence to develop and market RXC006, a porcupine inhibitor for fibrotic diseases including idiopathic pulmonary fibrosis (IPF).

Redx will receive up to $17m in early payments between signing the deal and the successful start of the first clinical trial.

The biotech based at AZ’s former UK R&D site in Alderley Park, Cheshire, could receive a further $360 million in development and commercial milestones plus tiered royalties.

Redx is also eligible for tiered royalties of mid-single digit percentages, based on any future net sales.

In the meantime Redx will continue to develop its lead cancer drug, RXC004, which is also a porcupine inhibitor and is in a phase 1/2 clinical trial.

US-based investment group Redmile acquired Redx earlier this year, and Redx finances were put on a firmer footing when it raised $30m by issuing convertible loan notes to Redmile Group and Sofinnova at the end of June.

The deal consisted of a $29m loan and a $1m investment and gave the company enough funding to carry on its R&D work into next year.

The RXC006 deal makes sense for AstraZeneca, which has respiratory diseases as one of its main focus areas, although IPF is being targeted by other pharma companies too.

Mene Pangalos, executive vice president BioPharmaceuticals R&D, AstraZeneca said: “Fibrotic diseases such as idiopathic pulmonary fibrosis have significant impact on patients’ lives and new therapies are urgently needed.

“We look forward to progressing this porcupine inhibitor into clinical trials as a novel approach to suppress Wnt signalling and potentially modify fibrotic disease processes.”

IPF is a progressive and life-threatening disease caused by scarring to the lungs and Boehringer Ingelheim is currently one of the major players in the market with its Ofev (nintedanib), with competition from Roche’s Esbriet (pirfenidone).

Last year Roche bought US biotech Promedior for $1.39bn, adding a potential IPF drug to its portfolio, and Belgium’s Galapagos has a potential IPF drug in phase 3 clinical development with Gilead with a readout due next year.

Porcupine inhibition is a novel anti-fibrotic approach that suppresses Wnt ligand secretion from pro-fibrotic cells.

Wnt ligands are known to be strong drivers of fibrotic mechanisms and are highly expressed in diseases such as IPF.

Wnt ligands regulate multiple aspects of disease biology so porcupine inhibition presents a potentially powerful anti-fibrotic approach.

 

The post Redx shares soar after IPF drug licence deal with AstraZeneca appeared first on .

The FDA’s approval of AstraZeneca’s SGLT2 inhibitor Farxiga in heart failure was a first for the class, but Boehringer Ingelheim and Eli Lilly are closing the gap with a positive pivotal trial for their rival drug Jardiance.

Top-line data from the phase 3 EMPEROR-Reduced study have shown that Jardiance (empagliflozin) beat out placebo on the primary objective of reducing death and hospitalisation rates in heart failure patients with and without diabetes.

The study was carried out in heart failure patients with reduced ejection fraction (HFrEF), the same group for which AZ claimed an FDA approval for Farxiga (dapagliflozin) in May.

Boehringer and Lilly now plan to present the data from EMPEROR-Reduced at the European Society of Cardiology (ESC) congress next month, and start filing for approval of Jardiance for HFrEF before the end of the year.

Jardiance was the top-selling drug in the SGLT2 inhibitor class with sales of almost $3 billion last year helped by side-effect problems that have afflicted Johnson & Johnson’s first-to-market Invokana (canagliflozin).

Farxiga has been gaining ground quickly however, with sales topping $1.5 billion in 2019 and growing another 20% in the first half of 2020, despite the impact of the coronavirus pandemic.

“The results of the EMPEROR-Reduced trial indicate that SGLT2 inhibitors have the potential to become a new standard of care for this disease, which will be a meaningful addition to currently established treatments,” said lead investigator Milton Packer of Baylor University Medical Center in Dallas.

Analysts at GlobalData have suggested that heart failure could add billions to the sales of the two SGLT2 inhibitors, particularly if they also claim approvals in heart failure with preserved ejection fraction (HFpEF), a larger patient population.

GlobalData has predicted that Farxiga will reach peak sales of $9 billion in 2028, while Jardiance is forecast to reach $4.6 billion, assuming a launch for HFrEF in 2021.

The bulk of those sales will come from HFpEF, which has “a huge unmet need and no specific standard of care,” it says.

AZ will however start losing patent protection for its drug in the coming years, depending on the outcome of patent litigation, so the launch of generics could rein in the SGLT2 market.

There have been numerous trial failures in HFpEF in recent years, including Novartis’ big selling heart failure therapy Entresto (sacubitril/valsartan), and Farxiga, Jardiance, and Merck & Co/Bayer’s vericiguat are the only drugs with positive data in this form of heart failure.

Boehringer and Lilly are waiting for the results of the EMPEROR-Preserved next year, while AZ is testing Farxiga in the DELIVER trial in HFpEF, with additional data on both HFrEF and HFpEF due from the DETERMINE study. Both of those Farxiga trials are also due to read out in 2021.

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