RNAi biotech Atalanta debuts with $110m plus Biogen and Roche CNS tie-ups

US biotech Atalanta Therapeutics has come out of stealth mode backed with $110m from Biogen and Roche, who have also signed separate partnerships to develop new therapies for neurological diseases using RNA interference (RNAi) technology.

While there are RNAi products on the marketplace, with Alnylam becoming the first company to get a product approved in 2018, it is difficult to get this class of drug distributed through the brain and spinal cord.

But with new technology based on branched silencing RNA licensed from the University of Massachusetts Medical School, Atalanta says it could change this.

Co-founded by Craig Mello, who won the Nobel Prize for Physiology or Medicine in 2006 for his work on RNAi, the company says the technology could be used to treat central nervous system diseases such as Huntington’s, Alzheimer’s and Parkinson’s.

Atalanta has actually been working since 2018 with co-founders Anastasia Khvorova, a UMass biochemist and Neil Aronin, a professor from University of Massachusetts Medical School, providing early leadership.

The company hired Alicia Secor as CEO in summer of 2019, who has previously been CEO of Juniper Pharmaceuticals and serves on the boards of neurology and rare diseases firms GW Pharmaceuticals and Orchard Therapeutics.

Atalanta starts life with two different strategic collaborations with its big pharma backers.

The partnership with Biogen will develop RNAi therapeutics for multiple targets, including HTT for the treatment of Huntington’s disease, as well as additional unnamed CNS targets.

Atalanta will be eligible to receive development and milestone payments as well as undisclosed royalties on any resulting products.

The strategic collaboration with Genentech entails the development of RNAi therapeutics for multiple CNS targets for neurodegenerative diseases, including Parkinson’s disease and Alzheimer’s disease.

This could also result in development and milestone payments and royalties.

Unprecedented and astounding

In an interview with pharmaphorum Secor said that the technology comes from a discovery in Khvorova’s lab, which showed the technology allowed potent silencing of Huntington’s for six months in mice.

In 2019 results were published in Nature Biotechnology of the research findings, which were described by Secor as “unprecedented and astounding”.

The founders formed the company with backing from investor F-Prime Capital and has just launched its Series A round with Roche’s Genentech unit and Biogen the first to invest.

Secor said: “In my 30 years I have never seen this level of interest.”

The technology could be used in several indications, according to chief scientific officer and RNAi expert Aimee Jackson.

“There is distribution to multiple regions and deep brain structures and enhanced potency and duration of action,” she said.

With the backing the company already has, Secor said the plan is to focus on preclinical development without needing to worry about funding for the time being.

Quizzed about the possibility of an IPO or buyout from a big pharma company, Secor said the focus is very much on developing the technology.

She told pharmaphorum: “Our long-term vision is to be discovery research and commercialisation platform and product company for a very long time.

“We have a long cash runway to do some building,” she added.

Female leadership

Secor also noted the strong role that women have played in founding and running the company, noting that the name Atalanta refers to the famous female character from Greek mythology.

It also reflects the contribution from Khorova as the founder of the company.

There’s also a connection with Greek mythology from the name of the protein that is targeted by the RNAi drug in Huntington’s – Argonaute 2.

In many versions of Jason’s quest for the Golden Fleece, Atalanta served as the only woman on the crew of the Argo.

Secor noted the recent appointments of Emma Walmsley and Reshma Kewalramani as CEOs at GlaxoSmithKline and Vertex, respectively.

She told pharmaphorum: “I wanted to keep the name to remind us we were named after a woman.

“I think there is a big movement around diversity and inclusion its an opportunity to break through those glass ceilings women should be feeling empowered to take leadership roles.

“It creates a whole lot of opportunities for women. This is a good time for women and I am excited to see more women step into leadership roles.”

 

 

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PharmaShots Weekly Snapshot (Jan 4-8, 2020)

Almirall and Tyris Collaborate to Develop Next Generation Gene Therapies

Published: Jan 7, 2020 | Tags: Almirall, Tyris, Collaborate, Develop, Next Generation, Gene Therapies

Sarepta Reports Mixed Results of SRP-9001 (rAAVrh74.MHCK7.micro-dystrophin) in Part 1 of Study 102 for DMD   

Published: Jan 7, 2020 | Tags: Sarepta, Reports, Mixed Results, SRP-9001, (rAAVrh74.MHCK7.micro-dystrophin), Part 1, Study 102, DMD

PerkinElmer to Acquire Oxford Immunotec for ~$591M

Published: Jan 7, 2020 | Tags: PerkinElmer, Acquire, Oxford Immunotec, ~$591M

Pfizer Reports the First Patients Dosing of PF-06939926 in P-III CIFFREO Study for DMD

Published: Jan 7, 2020 | Tags: Pfizer, Reports, First, Patients, Dosing, of PF-06939926 in P-III CIFFREO Study for DMD

Alnylam Reports Results of Vutrisiran in P-III HELIOS-A Study for Patients with hATTR Amyloidosis with Polyneuropathy

Published: Jan 7, 2020 | Tags: Alnylam, Reports, Results, Vutrisiran, P-III, HELIOS-A, Study, Patients, hATTR Amyloidosis, Polyneuropathy

Bayer Collaborates with CureVac for CVnCoV Against COVID-19

Published: Jan 7, 2020 | Tags: Bayer, Collaborates, CureVac, CVnCoV, Against, COVID-19

Hologic to Acquire Biotheranostics for ~$230M

Published: Jan 7, 2020 | Tags: Hologic, Acquire, Biotheranostics, ~$230M

Pfizer Signs a License and Supply Agreement with ImaginAb for CD8 ImmunoPET Technology

Published: Jan 6, 2020 | Tags: Pfizer, Signs, License, Supply, Agreement, ImaginAb, CD8 ImmunoPET Technology

Merck KGaA Acquires AmpTec to Strengthen its mRNA Capabilities for Vaccines, Treatments and Diagnostics

Published: Jan 6, 2020 | Tags: Merck KGaA, Acquires, AmpTec, Strengthen, mRNA, Capabilities,  Vaccines, Treatments, Diagnostics

Genentech Signs ~$1B Pact with Ribometrix to Develop RNA-Targeted Small Molecule Therapies

Published: Jan 6, 2020 | Tags: Genentech, Signs, ~$1B, Pact, Ribometrix, Develop, RNA-Targeted, Small Molecule Therapies

Astellas Reports the US FDA’s Acceptance of Priority Review for its NDO Therapy

Published: Jan 6, 2020 | Tags: Astellas, Reports, US, FDA, Acceptance, Priority Review, NDO Therapy, Myrbetriq, mirabegron, tablets, oral suspension

Pfizer Collaborates with Dewpoint to Develop Therapies for Rare Form of Muscular Dystrophy

Published: Jan 6, 2020 | Tags: Pfizer, Collaborates, Dewpoint, Develop, Therapies, Rare Form of Muscular Dystrophy

 Nirmidas Receives the US FDA’s EUA for its COVID-19 Rapid Antibody Fingerstick Test    

Published: Jan 6, 2020 | Tags: Nirmidas, Receives, US, FDA, EUA, COVID-19, Rapid, Antibody, Fingerstick Test

AstraZeneca’s Farxiga (dapagliflozin) Receives the US FDA’s Priority Review for Chronic Kidney Disease

Published: Jan 6, 2020 | Tags: AstraZeneca, Farxiga, (dapagliflozin), Receives, US, FDA, Priority Review, Chronic Kidney Disease

AbbVie Reports Results of Skyrizi (Risankizumab) in P-III Studies for Active Psoriatic Arthritis

Published: Jan 5, 2020 | Tags: AbbVie, Reports, Results, Skyrizi, (Risankizumab), P-III, Studies, Active Psoriatic Arthritis

Regenxbio Reports the Initiation of First Pivotal Program for RGX-314 to Treat Wet AMD

Published: Jan 5, 2020 | Tags: Regenxbio, Provide, Update, RGX-314, Treat, Wet AMD, RGX-202

Evotec Receives Milestones in its Neurodegeneration Collaboration with BMS

Published: Jan 5, 2020 | Tags: Evotec, Bristol Myers Squibb, $6M, Milestones

Stryker Acquires OrthoSensor and its Knee Surgery Sensor Technology

Published: Jan 5, 2020 | Tags: Stryker, Acquires, OrthoSensor, Knee Surgery Sensor Technology

Biogen Signs a License Agreement with ViGeneron for Ophthalmic Gene Therapy Development

Published: Jan 4, 2020 | Tags: ViGeneron, Signs, Global License Agreement, Biogen, Ophthalmic Gene Therapy, Development

 Y-Biologics Signs a License Agreement with 3D Medicines for YBL-013 in the Territory of Greater China

Published: Jan 4, 2020 | Tags: Y-Biologics, signed, License Agreement, 3D Medicines, Develop, Manufacture, Commercialize, YBL-013

aTyr Reports Results of ATYR1923 in P-ll Study for COVID-19 Patients with Severe Respiratory Complications

Published: Jan 4, 2020 | Tags: aTyr Pharma, Report, Positive Results, ATYR1923, P-ll Study, COVID-19

Genentech’s Tiragolumab + Tecentriq Receive the US FDA’s Breakthrough Therapy Designation for PD-L1-High Non-Small Cell Lung Cancer

Published: Jan 5, 2020 | Tags: Genentech, Tiragolumab + Tecentriq, Receives, US FDA’s, Breakthrough Therapy Designation, PD-L1-High Non-Small Cell Lung Cancer

Pfizer and OPKO Reports the US FDA’s Acceptance of BLA for Somatrogon to Treat Pediatric Patients with Growth Hormone Deficiency

Published: Jan 4, 2020 | Tags: Pfizer, OPKO, Reports, US FDA, Acceptance, BLA, Somatrogon, Treat, Growth Hormone Deficiency (GHD)

 Hologic to Acquire Somatex for ~$64 M   

Published: Jan 4, 2020 | Tags: Hologic, Acquire, Somatex, $64 M

Provention Bio Reports Submission of BLA and Priority Review to the US FDA for Teplizumab to Prevent T1D  

Published: Jan 3, 2020 | Tags: Provention Bio, Reports, Submission, BLA, Priority Review, US, FDA, Teplizumab, Prevent, T1D

Oura Ring Monitors Body Temperature and Identify Early COVID-19 Symptoms

Published: Jan 2, 2020 | Tags: Oura Ring Monitors, Body Temperature, Identify, Early, COVID-19, Symptoms

Tiziana Completes Clinical Trial of Nasally Administered Foralumab for COVID-19 in Brazil

Published: Jan 3, 2020 | Tags: Tiziana, Completes, Clinical Trial, Nasally, Administered, Foralumab, COVID-19, Brazil

 Antengene Reports NDA Submission for ATG-010 (Selinexor) to Treat RRMM and RR DLBCL in South Korea     

Published: Jan 3, 2020 | Tags: Antengene, Reports, NDA, Submission, ATG-010, (Selinexor), RRMM, RR DLBCL, South Korea

AstraZeneca’s COVISHIELD Receives EUA in India for COVID-19

Published: Jan 4, 2020 | Tags: AstraZeneca, COVISHIELD, Receives, EUA in India

RedHill Reports Results of Yeliva (opaganib) in P-II Study for COVID-19

Published: Jan 3, 2020| Tags: RedHill, Reports, Results, Yeliva, (opaganib), P-II, Study, COVID-19

Related Post: PharmaShots Weekly Snapshots (Dec 28- 31, 2020)

The post PharmaShots Weekly Snapshot (Jan 4-8, 2020) first appeared on PharmaShots.

Genentech Signs ~$1B Pact with Ribometrix to Develop RNA-Targeted Small Molecule Therapies

Shots:

  • Ribometrix to receive $25M up front, ~$1B+ as milestones along with royalties on sales of therapies emerges from the collaboration
  • The companies collaborated on the discovery & preclinical development of programs. Genentech will lead further development and commercialization and will have exclusive rights to several predefined targets including an exclusive global license for the development and commercialization of molecules
  • Ribometrix will leverage its discovery platform to identify & optimize small molecule compounds modulating RNA function by targeting 3D RNA structures

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: New Indian Express

The post Genentech Signs ~$1B Pact with Ribometrix to Develop RNA-Targeted Small Molecule Therapies first appeared on PharmaShots.

ViewPoints Interview: Genentech’s Ted Omachi Shares Insight on the US FDA’s Approval of Xolair in Nasal polyps

In a recent interview with PharmaShots, Ted Omachi, Global Development Leader for Xolair, and Senior Medical Director of Product Development for Immunology, Genentech shared his views on the approval of Xolair in the US.

Shots:

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

Tuba: Can you please shed some light on Nasal Polyps? (causes, symptoms, epidemiology, etc.)

Ted: Approximately 13 million people in the U.S. are impacted by nasal polyps, a commonly occurring condition in adults that may be refractory to treatments such as nasal corticosteroids and even surgery. Nasal polyps present as noncancerous growths on the lining of the nasal sinuses or nasal cavity associated with irritation and inflammation and, as such, they can block normal airflow. Nasal polyps may also co-occur with other respiratory conditions, such as allergies and asthma. They may become quite large and develop in both nostrils, leading to a loss of smell, nasal congestion, chronic runny nose, and post-nasal drip. This condition can cause significant long-term symptoms and impact on patients’ lives. While the pathophysiology of nasal polyps is not entirely elucidated, we know that it is an inflammatory condition in which immunoglobulin E (IgE) plays an important role.

Tuba:  A quick highlight of clinical data submitted for the approval of Xolair in nasal polyps to the U.S. FDA.

Ted: The FDA’s approval is based on results from the Phase III POLYP 1 and POLYP 2 pivotal trials conducted in adult patients. To be enrolled in the study, patients needed to have large polyps in both nostrils and significant symptoms, with persistent symptoms and large polyps even after treatment with nasal steroids. Patients were then given either Xolair or placebo, in a blinded fashion, while continuing to receive nasal steroids. Patients who received Xolair had statistically significantly greater improvements, as compared to placebo, over the approximate six-month duration of the study, from baseline to Week 24, in both of the co-primary endpoints: Nasal Polyp Score (NPS) and Nasal Congestion Score (NCS). NPS is an objective measure of the size of the polyps, as determined by endoscopy, while NCS is a measure of the degree of nasal blockage, as determined by patients’ assessment of their own symptoms. The greater improvements in NPS and NCS in the Xolair group as compared to the placebo group were observed as early as the first assessment at Week 4 in both studies. They also had statistically significant improvements in smell, post-nasal drip, and runny nose. The safety profile in POLYP 1 and POLYP 2 was consistent with the established safety profile for Xolair, which is based on more than 17 years of real-world experience in allergic asthma and more than 1.3 million patient-years of usage in clinical practice. 

Tuba: Can you explain how Xolair works for nasal polyps (mechanism of action)?

Ted: Xolair is the first biologic for the treatment of nasal polyps that targets and blocks immunoglobulin E (IgE), a key driver of inflammation. By reducing free IgE, down-regulating high-affinity IgE receptors and limiting mast cell degranulation, Xolair minimizes the release of mediators throughout the allergic inflammatory cascade.

Tuba: Can you provide some insights on RoA for Xolair in Nasal Polyps?

Ted: We do not comment on sales forecasts or projections.

Tuba:  Can our readers have more details on any ongoing and upcoming patients support programs and efforts for patient adherence?

Ted: As a physician, I know firsthand that adherence and access to medicines are some of the most important factors to ensure the safety and effectiveness of treatment for patients. At Genentech, we are committed to helping patients access to the medicines prescribed by their physician, even if they can’t afford them. For more than 20 years, we have helped more than 2.2 million people get the medicine they need through patient assistance programs like Genentech Access Solutions and the Genentech Patient Foundation.

Tuba: Xolair is now approved in multiple indications including allergic asthma, CIU and nasal polyps. What’s next?

Ted: We are committed to exploring the full potential of Xolair across a range of respiratory diseases.

In August 2020, the FDA accepted our sBLA for a new self-injection option for Xolair prefilled syringe formulation across all approved US indications, with a decision on approval anticipated in Q1 2021.

Additionally, in 2018 the FDA granted Breakthrough Therapy Designation to Xolair as a potential treatment for food allergies. Xolair is currently being investigated as a potential treatment for multiple food allergies in Phase III clinical trial, Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen Oral Immunotherapy in Food Allergic Children and Adults, or OUtMATCH trial. The trial is supported by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, Genentech, and Novartis. We are hopeful about the potential to address this area of the significant need for patients as there are limited FDA-approved treatments that help prevent severe reactions due to food allergies.

Tuba: Are you focusing on approvals in different countries?

Ted: Xolair is approved for nasal polyps-related conditions in several countries outside of the U.S. In August 2020, the European Commission approved Xolair as add-on therapy with intranasal corticosteroids for the treatment of adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP) for whom therapy with intranasal corticosteroids does not provide adequate disease control. Additionally, Xolair is approved in more than 10 other countries throughout the world for nasal polyps or CRSwNP. Further regulatory reviews of Xolair to treat patients with CRSwNP (often referred to as nasal polyposis) are currently underway in multiple countries.

Tuba: What kind of pricing difference shall be expected for Xolair for Nasal Polyps vs. Xolair for other indications?

Ted: When determining the prices of our medicines, we take into consideration a number of factors including clinical benefit, patient access, investments required for future medications, and our responsibility to patients, society, and shareholders. The dosing of Xolair for nasal polyps and allergic asthma depends on the patient’s weight and serum IgE levels, which affects the cost of therapy.

About Ted Omachi:

Ted Omachi is a Medical Director in the Product Development Immunology group at Genentech, focusing on late-stage development in respiratory and allergic diseases. He joined Genentech in 2013, starting in the Medical Affairs group before transitioning to Product Development in 2015.

Related Post:  ViewPoints Interview: Genentech’s Ted Omachi Shares Insights on Xolair (omalizumab) PFS

The post ViewPoints Interview: Genentech’s Ted Omachi Shares Insight on the US FDA’s Approval of Xolair in Nasal polyps first appeared on PharmaShots.

Genentech’s Tiragolumab + Tecentriq Receive the US FDA’s Breakthrough Therapy Designation for PD-L1-High Non-Small Cell Lung Cancer

Shots:

  • The BTD is based on P-II CITYSCAPE study assessing Tiragolumab + Tecentriq vs Tecentriq + PBO as a 1L treatment of 135 patients in a ratio (1:1) with LA unresectable metastatic NSCLC whose tumors have high PD-L1 expression with no EGFR
  • Result: improvement in ORR (37% vs 21%); reduction in the risk of disease worsening or death (42%); ORR (66% vs 24%); m-PFS (not reached vs 4.11 mos.); Grade 3 AEs (48% vs. 44%)
  • Tiragolumab is a mAb designed to bind with TIGIT and works as an immune amplifier, by potentially enhancing the body’s immune response. The company is evaluating the tiragolumab across various settings in different tumor types, including lung, esophageal and cervical cancers

Click here ­to­ read full press release/ article | Ref: BusinessWire | Image: Magic Number IP

The post Genentech’s Tiragolumab + Tecentriq Receive the US FDA’s Breakthrough Therapy Designation for PD-L1-High Non-Small Cell Lung Cancer first appeared on PharmaShots.

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

Shots:

  • Relay to receive $75M as upfront, $25M in additional near-term payments, and has the right to opt for 50/50 profit/cost-sharing on RLY-1971 in the US. If Relay exercises the option, it will be eligible to receive 50% profits on US sales & ~$410M as commercialization milestones & royalties on ex-US sales
  • If Relay elects not to opt-in, then it will receive ~$695M as milestones along with royalties on global sales of RLY-1971
  • Genentech will assume the development of RLY-1971 with the potential to expand into multiple combination studies including its GDC-6036 (KRAS G12C inhibitor). The relay will receive additional royalties on the approval of IRLY-1971 + GDC-6036

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

The post Genentech Signs a Worldwide License Agreement with Relay Therapeutics to Develop and Commercialize RLY-1971 first appeared on PharmaShots.

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

Shots:

  • The approval is based on ENSEMBLE PLUS study, which demonstrated similar frequency and severity of IRRs for 2hrs. Ocrevus infusion time vs conventional 3.5hrs in patients with RRMS. The initial dose is given as two 300mg infusions given 2wks. apart and a subsequent dose of single 600mg infusions were administered over a shorter, 2hrs. time
  • Results: frequency of IRRs post 600mg infusion (24.6% vs 23.1%), majority of IRRs were mild or moderate, and >98% resolved in both groups without complication
  • Ocrevus is a humanized mAb designed to target CD20-positive B cells and is the first and only therapy approved for both RMS and PPMS

Click here ­to­ read full press release/ article | Ref: Genentech | Image: Xconomy

The post Genentech’s Ocrevus Shorter 2-Hour Infusion Receives the US FDA’s Approval for Relapsing & Primary Progressive Multiple Sclerosis first appeared on PharmaShots.

Insights+ Key Biosimilars Events of November 2020

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients. Hence, the providers are more likely to adopt biosimilars as a “reference product to biologics” possessing similar therapeutic properties. During the month of November, Formycon and Bioeq reported the first patient dosing in the P-III study of FYB202 while Prestige collaborated with Teva to commercialize Tuznue. Our team at PharmaShots has summarized 21 key events of the biosimilar space of Nov 2020.

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

Published: 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)

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

Published: Nov 06, 2020

Product: FYB201 (biosimilar, ranibizumab)

  • Formycon & Bioeq reported the BLA resubmission strategy for FYB201 (biosimilar referencing Lucentis) has been adjusted
  • With the revised submission strategy, the companies expect a simplification of the approval procedure. The modified submission dossier is anticipated to be filed with the US FDA in H1’21
  • The adjustment of the regulatory strategy while optimizing the commercial supply chain is not expected to have any impact on the timing of the anticipated launch of FYB201 in the US & EU

Formycon and Bioeq Reported First Patient Dosing in P-III Study of FYB202 (biosimilar, ustekinumab)

Published: Nov 09, 2020

Product: FYB202 (biosimilar, ustekinumab)

  • The focus of the P-III study is to demonstrate the comparability of FYB202 & the reference product Stelara in terms of efficacy, safety & immunogenicity in patients with moderate to severe psoriasis vulgaris
  • FYB202 is being developed as part of JV b/w Aristo Pharma & Formycon along with Bioeq. Bioeq is responsible for the clinical studies which were developed in close cooperation with the US FDA & the EMA
  • The ustekinumab is mAb targeting the cytokines IL-12 & IL-23. Stelara is used to treat various severe inflammatory conditions such as mod. to sev. psoriasis, CD & for UC

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

Published: Nov 09, 2020

Product: Biosimilar

  • Alvotech and Cipla entered an exclusive partnership to provide patients with better access to high quality and cost-effective biosimilar medicines in South Africa
  • Alvotech will be responsible for the development and supply of the products and Cipla will be responsible for the registration and commercialization
  • The biosimilar portfolio will include five biosimilars- two for oncology and three for treating auto-immune diseases

Genentech Filed Complaint Against Centus Over Proposed Bevacizumab Biosimilar

Published: Nov 13, 2020

Product: Proposed Bevacizumab Biosimilar

  • Genentech filed a complaint in the Eastern District of Texas alleging that the proposed biosimilar to Avastin (bevacizumab) product infringes 10 US patents
  • Genentech alleges that Centus and partners failed to disclose sufficient information about the proposed biosimilar to enable Genentech to do a sufficient analysis of potential patent infringements
  • Centus has a BLA under review with the FDA for the bevacizumab biosimilar candidate FKB238, and the company has filed a notice of intent to commercialize the agent

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

Published: Nov 11, 2020

Product: Tuznue (biosimilar, trastuzumab)

  • Teva to get an exclusive right to commercialize Tuznu in Israel, leveraging its marketing capabilities and experience in bringing pharmaceutical products to market and will be responsible for local registration, sales, and marketing in Israel
  • Prestige will assume responsibility for product registration with the EMA and commercial supply of Tuznue from its manufacturing facilities in Osong, Korea
  • Tuznue is biosimilar referencing Roche’s Herceptin (trastuzumab), used to treat HER2-overexpressing BC & m-gastric adenocarcinoma. Additionally, the EMA has accepted an MAA for Tuznue based on the global clinical trial results

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

Published: Nov 11, 2020

Product: SB16 proposed biosimilar to Prolia

  • The P-I study assesses the PK/PD, safety, tolerability of SB16 (denosumab) vs Prolia in 168 healthy male volunteers for osteoporosis. The study will be 3 arms study that involves dosing with SB16 either the EU or US-sourced Prolia
  • The proposed biosimilar references Amgen’s Prolia which was approved in 2010 for osteoporosis with a high risk of fracture
  • With the initiation, Samsung Bioepis continues to advance its biosimilar portfolio covering immunology, oncology, ophthalmology, and hematology

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

Published: Nov 11, 2020

Product: HLX14 (denosumab, biosimilar)

  • The first patient has been dosed in a P-I study of HLX14, conducted in 2 parts, Part 1 is a pilot study assessing PK/PD, safety, tolerability & immunogenicity of HLX14 vs EU-sourced denosumab (SC) in healthy male volunteers
  • Part 2 is a four-arm study assessing the bioequivalence of HLX14 vs US-, EU-, CN-sourced denosumab. The study also evaluates PD, safety, tolerability, and immunogenicity between HLX14 and the reference drug
  • Results from the P-I study will provide reference for the dosing scheme in the clinical studies of HLX14

Xbrane Reported Patient Enrollment Completion in P-lll XPLORE Study of Xlucane (biosimilar, ranibizumab)

Published: Nov 11, 2020

Product: Xlucane (biosimilar, ranibizumab)

  • Xbrane reported that the last patient has been enrolled into the P-III XPLORE study assessing Xlucane vs Lucentis in 580 patients with wet AMD
  • The company will conduct an interim read-out from the XPLORE study when the last patient has reached 6mos. of their treatment schedule. Top-line data is expected to be communicated mid-2021 and filing of the MAA/BLA to EMA and the US FDA anticipated to take place imminently
  • Filing of MAA/BLA is expected to take place mid-2021. With an expected 12mos. regulatory process upon filing, MAA is expected in the EU and the US mid-2022 allowing for the launch of Xlucane

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

Published: Nov 16, 2020

Product: HLX15 (biosimilar, daratumumab)

  • 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

Samsung Bioepis Presented Results of SB11 Proposed Biosimilar to Lucentis in P-III Study at the AAO 2020 Virtual

Published: Nov 16, 2020

Product: SB11 proposed biosimilar to Lucentis

  • The P-III study involves assessing SB11 vs reference ranibizumab in monthly injections (0.5 mg) in 705 patients in a ratio (1:1) with nAMD while only 634 patients continued to receive treatment up to 48wks.
  • One-year results from the P-III study demonstrated equivalence between SB11 and reference ranibizumab in patients with nAMD
  • The study met its 1EPs i.e. changes from baseline in BCVA @8wks. and CST @4wks. The EMA has accepted for review the MAA of SB11 in Oct’2020

Samsung Bioepis and Biogen Reported the FDA’s Acceptance of BLA for SB11 Proposed Biosimilar to Lucentis

Published: Nov 18, 2020

Product: SB11 proposed biosimilar to Lucentis

  • The US FDA has accepted for review the BLA of SB11, a proposed biosimilar referencing Lucentis (ranibizumab)
  • The EMA has accepted for review the MAA of SB11 in Oct’2020. If approved, SB11 will add to the biosimilars portfolio developed under the collaboration of Samsung Bioepis and Biogen including Benepali, Imraldi & Flixabi
  • In Nov’2019, Samsung Bioepis entered into a commercialization agreement with Biogen for 2 ophthalmology biosimilar candidates, SB11 (ranibizumab) & SB15 (aflibercept) in the US, Canada, Europe, Japan & Australia. Ranibizumab is an anti-VEGF therapy for retinal vascular disorders

The US FDA Draft New Guidelines for Biosimilarity and Interchangeability

Published: Nov 19, 2020

Product: Biosimilar

Shots:

  • The FDA has released a draft guidance for industry entitled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act”
  • The draft guidance is intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable products, as well as describe FDA’s interpretation of statutory requirements added by the BPCI Act
  • The draft guidance is to be published in the Federal Register on Nov 20, 2020

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

Product: Nov 20, 2020

Product: AVT02, a proposed biosimilar to Humira

  • The US FDA has accepted the BLA of AVT02 for review and is expected to decide on the filing in Sept’2021 while the EMA has accepted for review an MAA for AVT02 with an EMA decision anticipated in the Q4’21
  • The filings were based on AVT02-GL-101 & AVT02-GL-301 studies demonstrating a high degree of similarity b/w AVT02 and the reference products. AVT02-GL-101 study met its 1EPs of PK similarity while the later study confirmed the efficacy and safety of AVT02 in patients with mod. to sev. chronic psoriasis
  • AVT02 is a proposed biosimilar to the reference product Humira (adalimumab) with high concentration (100mg/mL) dosage forms

Henlius Presented Results of HLX04 (biosimilar, bevacizumab) in P-III Study at ESMO Asia 2020

Published: Nov 20, 2020

Product: HLX04 (biosimilar, bevacizumab)

  • The P-III HLX04-mCRC03 study involves assessing the efficacy, safety and immunogenicity of HLX04 vs reference bevacizumab (7.5 mg/kg, q3w or 5 mg/kg, q2w) + CT (Xelox or mFOLFOX6) as a 1L treatment in patients in the ratio of (1:1) with mCRC
  • Result: PFSR36wk (46.4% vs 50.7%); no significant difference b/w the treatment groups in 2EPs including OS, PFS, ORR, TTR and DoR; safety and immunogenicity profiles were similar b/w HLX04 and the reference
  • The NMPA has accepted the NDA for HLX04. Additionally, Henlius has submitted a patent for a new formulation of HLX04 with potential better safety and stability, designed for ophthalmic use

Samsung Biologics and AstraZeneca Dissolved Rituximab Alliance

Published: Nov 20, 2020

Product: SAIT101 (biosimilar, rituximab)

  • Samsung Biologics and AstraZeneca had decided to suspend long-running research and development activities by a jointly owned subsidiary, Archigen Biotech, which was solely engaged in development of SAIT101 (biosimilar, rituximab)
  • Samsung halted the P-III study of SAIT101 in Oct’2012 and resumed it in 2014 via Archigen. The P-III study similar therapeutic effect to Rituxan in 315 FL patients with ORR (66.3% vs 70.6%)
  • The companies decided to stop commercializing SAIT101 and take step for liquidation of Archigen as the product lacks commercial viability

The US FDA Approved Pfizer’s Oncology Supportive Care Biosimilar Nyvepria (biosimilar, pegfilgrastim)

Product: Nov 20, 2020

Product: Nyvepria (biosimilar, pegfilgrastim)

  • The EC has approved Nyvepria, a biosimilar referencing Neulasta to reduce the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic CT for malignancy
  • The EC approval is based data demonstrating a high degree of similarity of Nyvepria to its reference product
  • Pfizer plans to make Nyvepria available to patients in multiple EU countries starting in Q1’21. The EC’s approval follows the US FDA’s approval granted in Jun’2020

Innovent Reported Results of Tyvyt + Byvasda (biosimilar, bevacizumab) in P-lll ORIENT-32 Study as 1L Treatment for HCC

Product: Nov 23, 2020

Product: Byvasda (biosimilar, bevacizumab)

  • The P-lll ORIENT-32 study involves assessing of Tyvyt (sintilimab) + Byvasda vs sorafenib as a 1L treatment in 571 patients in a ratio (2:1) with advanced HCC and the result were released in an oral presentation at the ESMO Asia Virtual Congress 2020
  • Result: Reduction in risk of all-cause mortality (43.1%); the median OS (not reached vs 10.4 mos.); reduction in risk of progression (43.5%); m-PFS (4.6 vs 2.8 mos.), results was presented at ESMO 2020
  • The improved OS and PFS benefits of the dual regimen were generally consistent across all subgroups and showed an acceptable safety profile with no new safety signals

Innovent’s Sulinno (biosimilar, adalimumab) Received NMPA’s Approval for Polyarticular Juvenile Idiopathic Arthritis

Published: Nov 23, 2020

Product: Sulinno (biosimilar, adalimumab)

  • The NMPA has approved Sulinno for the treatment of pJIA which is the fourth approved indication of the therapy in China. Earlier, Sulinno was approved for RA, PS, and psoriasis
  • The launch of Sulinno has provided more Chinese patients with high-quality and relatively affordable adalimumab injection, bringing hope and opportunities to more patients
  • Sulinno is a human anti-TNF-α mAb referencing Humira. The clinical results were published at the Inaugural Issue of The Lancet Rheumatology in 2019

Alvotech and Alvotech & CCHT Signed an Exclusive Commercialization Agreement with Yangtze River for Eight Biosimilars in China

Product: Nov 25, 2020

Product: Biosimilar

  • The companies collaborate with the Yangtze to commercialize eight biosimilars in China. The initial pipeline contains biosimilar candidates for the treatment of autoimmunity, ophthalmology, and oncology
  • Alvotech and Alvotech & CCHT will be jointly responsible for the development, registration, and supply of biosimilars in China while Yangtze River Pharmaceutical will exclusively commercialize the biosimilars
  • The manufacturing of biosimilars will be made in a new state-of-the-art biopharmaceutical facility, currently being built in Changchun, China, through the Alvotech & CCHT. The first phase of the facility is expected to be completed in 2021

Bio-Thera Reported MAA Submission to EMA for BAT1706 a Proposed Biosimilar to Avastin

Product: Nov 26, 2020

Product: BAT1706 (a proposed biosimilar to Avastin)

  • The company has submitted an MAAA for BAT1706 to EMA. Bio-Thera seeks a commercial license for all approved indications of bevacizumab in the EU Member States, Iceland, Norway, and Liechtenstein
  • The submission of the MAA for BAT1706 marks it as the first ex-China MAA/ BLA submission. The BLA of the biosimilar for metastatic carcinoma of the colon or rectum and NSCLC is under NMPA’s review
  • The company plans to submit a BLA for BAT1706 to the US FDA by the end of 2020. Bevacizumab is a mAb that targets VEGF thus reduces neovascularization, thereby inhibiting tumor growth

Related Post: Insights+ Key Biosimilars Events of October 2020

The post Insights+ Key Biosimilars Events of November 2020 first appeared on PharmaShots.

PharmaShots’ Key Highlights of Third Quarter 2020

The third quarter of 2020 was flooded with major acquisitions in the pharma and biotech industry along with multiple approvals. Starting with the latest acquisitions, Gilead acquired Immunomedics for ~$21B, Illumina acquired GRAIL for ~$8B, J&J acquired Momenta Pharmaceuticals for $6.5B and Nestlé acquired Aimmune Therapeutics for $2.6B, Sanofi acquired Principia Biopharma for ~$3.68B  Apart from acquisitions, big alliances were the highlights of the quarter which include Biogen collaboration with Denali on LRRK2 program for Parkinson’s Disease worth ~$2.125B, Sanofi’s agreement with Kymera to advance novel protein degrader therapies, Roche & UCB’s collaboration to develop UCB0107 for AD, Merck’s $4.5B oncology deal with Seattle Genetics. The third quarter of the year also showcases multiple approvals of the therapies which include Roche’s FDA’s approval for the VENTANA HER2 Dual ISH test as CDx, Genentech’ Gavreto (pralsetinib) got the US FDA’s approval for metastatic RET fusion-positive NSCLC. Meanwhile, AstraZeneca, J&J, and Novavax initiated the P-III development of their COVID-19 vaccine candidates. Our team at PharmaShots has summarized and complied with the insights of Q3’20.

Novavax Initiated P-III Study of its COVID-19 Vaccine in the UK

Date – Sept 25, 2020

Product – NVX-CoV2373

  • Novavax has initiated P-III study assessing the efficacy, safety and immunogenicity of NVX-CoV2373 vs PBO in Matrix-M in up to 10,000 individuals aged 18-84yrs. with/out relevant comorbidities, over the next 4-6wks.
  • Half the participants will receive two IM injections of vaccine comprising 5µg of protein antigen with 50µg Matrix‑M adjuvant, administered 21 days apart, while half of the trial participants will receive PBO
  • The 1EPs & 2EPs is the first occurrence of PCR-confirmed symptomatic COVID-19 & PCR-confirmed symptomatic mod. to sev. COVID-19 with the onset at least 7 days after second study vaccination in volunteers prior not infected with SARS-CoV-2 respectively. Novavax has continued to scale-up its manufacturing capacity, currently up to 2B annually

J&J Initiated Global P-III Clinical Study of its COVID-19 Vaccine

Date- Sept 24, 2020

Product- JNJ-78436735

  • The initiation of the ENSEMBLE trial follows positive interim results of P-I/IIa study demonstrating the safety and immunogenicity of JNJ-78436735 following a single vaccination. The results have been submitted to medRxiv and expected to be published imminently
  • The P-III ENSEMBLE study is design to assess the safety & efficacy of a single vaccine dose vs PBO in up to 60,000 adults aged ≥18yrs., including those that are over age 60. The trial will include both with/ out comorbidities associated with an increased risk for progression to severe COVID-19
  • The company will continue to ramp up its manufacturing capacity to meet its goal of providing 1B doses/year. J&J anticipates the first batches of a COVID-19 vaccine to be available for EUS in early 2021, if proven to be safe and effective

Illumina Acquired GRAIL for ~$8B

Date – Sept 22, 2020

Deal Value – ~$8B

  • Illumina to acquire GRAIL in cash & stock transaction for $8B including ~$3.5B in cash and $4.5B in shares of Illumina common stock. Illumina founded GRAIL in 2016 and later spun out it to develop state-of-the-art data science, ML and create the atlas of cancer signals in the blood, enabling multi-cancer early detection tests
  • GRAIL to receive CVR and future payments representing a pro rata portion of certain GRAIL-related revenues/ year for 12yrs., reflecting a 2.5% payment right to the first $1B of revenue each year for 12yrs. and 9% CVR if revenue is above $1B. Additionally, GRAIL to get the option to receive additional cash and/or stock consideration, prior to closing, in lieu of the CVR
  • The acquisition will transform cancer care using genomics and NGS platform and accelerates commercialization and adoption of transformative multi-cancer screening test with potential to detect cancer. GRAIL expects to launch Galleri in 2021 which can detect 50+ cancer indications

Fitbit to Launch ECG App in the US and EU in October 2020

Date – Sept 15, 2020

Product – ECG App

  • Fitbit’s ECG app has received the US FDA’s 510 (k) clearance and EC’s CE marking to assess heart rhythm for atrial fibrillation (AFib). The Fitbit ECG app will be available in Oct’2020 to the users on Fitbit Sense smartwatch
  • The company has launched a multi-site clinical trial across the US, to detect AFib from normal sinus rhythm and to generate an ECG trace, recording of a heart’s electrical rhythm, that is qualitatively like Lead I ECG. The study demonstrated that algorithm has an ability to detect 98.7% of AFib cases (sensitivity) and is 100% accurate in identifying study participants with normal sinus rhythm (specificity)
  • Fitbit Sense smartwatch is available today for pre-order on Fitbit.com with WW availability starting later this month and is available for $329.95 in carbon/graphite stainless steel and lunar white/soft gold stainless steel

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

Date – Sept 15, 2020

Product – Beovu (brolucizumab)

  • 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 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) which enhances tissue penetration, rapid clearance from 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

Gilead Acquired Immunomedics for ~$21B

Date – Sept 14, 2020

Deal Value – ~$21B

  • Gilead to acquire Immunomedics for $88.00/ share representing a 108% premium to Immunomedics’ closing price on Sept 11, 2020, making a total deal value $21B. The transaction is expected to be completed in Q4’20
  • The acquisition will add Immunomedic’s s Trodelvy to Gilead’s portfolio, expanding its oncology pipeline and accelerated its revenue and EPS growth. Additionally, the Trodelvy is being studied in an ongoing P-III study for 3L HR+/HER2- BC and a registrational P-II study in bladder cancer, NSCLC, and other solid tumors
  • Trodelvy (sacituzumab govitecan-hziy) is a Trop-2 directed ADC, received accelerated approved for mTNBC in the US while the company plans to submit the sBLA for the full approval of the therapy in Q4’20. Immunomedics is on track to file for regulatory approval in EU in the H1’21

Merck Signed Up to $4.5B Oncology Deal with Seattle Genetics

Date – Sept 14, 2020

Deal Value – ~$4.5B

  • Seattle Genetics to receive $600M up front, $1B as equity investment, 5M shares of Seattle Genetics common stock at a price of $200/ share, $2.6B as milestones including $850M development milestones and $1.75B as commercial milestones. The companies will equally share costs and profits on the global development of ladiratuzumab vedotin and other LIV-1-targeting ADCs
  • The companies will co-commercialize the therapy in the US and EU. Seattle Genetics will be responsible for approval in the US & Canada and will record sales in the US, Canada, and EU while Merck will be responsible for approval in EU & outside the US & Canada, and will record sales in countries outside the US, EU, and Canada
  • Additionally, companies enter exclusive license and co-development agreement to accelerate the global reach of Tukysa for HER2+ cancers in regions outside the US, EU & Canada. As per the agreement, Seattle Genetics to receive $125M as upfront and is eligible to receive up to $65M as progress-dependent milestones, $85M as research and development milestones, and royalties on sales of Tukysa in Merck’s territory

Novartis’ Kisqali (ribociclib) Received Highest Score on the ESMO Magnitude of Clinical Benefit Scale

Date – Sept 11, 2020

Product – Kisqali (ribociclib)

  • Novartis’ Kisqali + endocrine therapy has achieved 5 out of 5 score on ESMO-MCBS, confirming substantial benefit for premenopausal women with HR+/HER2- aBC, based on OS benefit and improved QoL in the P-III MONALEESA-7 study
  • Kisqali is also the only CDK4/6 inhibitor to receive a score of 4 out of 5 in combination with fulvestrant  for 1L postmenopausal women with HR+/HER2- aBC based on the OS benefit and maintained QoL observed in P-III MONALEESA-3. Additionally, Kisqali + fulvestrant receive a score of 4 out of 5 in 2L setting based on the MONALEEA-3 study
  • New data presented at ESMO 2020 add to the substantial body of evidence further differentiating Kisqali as the only CDK 4/6 inhibitor that improves OS in two P- III trials, with consistent results across patient subgroups, and with QoL benefits. Kisqali in patients with endocrine resistance led to a 30% & 41% reduction in the risk of death in the MONALEESA-3 & -7 studies over standard endocrine therapy respectively

AbbVie Licensed I-Mab’s Lemzoparlimab (TJC4) for ~$2B

Date – Sept 09, 2020

Deal Value – ~$2B

  • I-Mab to receive $180M upfront, $20M on P-I results and is eligible to receive $1.74B which include $840M as development & regulatory milestones while remaining as commercial milestones along with royalties on sales of the therapy outside China
  • AbbVie to get an exclusive global license (Ex-greater China) to develop and commercialize lemzoparlimab while I-Mab retain its right in China. Both the companies will conduct clinical trials to evaluate lemzoparlimab in multiple cancers while each partner have the potential to expand the collaboration to additional transformative therapies
  • The companies will have the opportunity to further licenses to explore each other’s related programs in their respective territories. Lemzoparlimab is an anti-CD47 mAb, designed to minimize inherent binding to normal RBCs while preserving its strong anti-tumor activity

Genentech’ Gavreto (pralsetinib) Received the US FDA’s Approval Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

Date – Sept 07, 2020

Product – Gavreto (pralsetinib)

  • The approval is based on P-I/II ARROW study assessing Gavreto (400mg, qd) in RET fusion-positive NSCLC patients with or without prior therapy, and regardless of RET fusion partner or CNS involvement. The study also involves patients with RET-MTC, RET fusion-positive thyroid cancer and other RET-altered solid tumors
  • Results: ORR (57%) and CR rate (5.7%) in 87 NSCLC patients prior treated with Pt. based CT, m-DOR was not reached, in 27 treatment-naïve NSCLC patients, ORR (70%); CR rate (11%). Gavreto is now the 6th FDA-approved medicine in Genentech’s portfolio for lung cancer
  • Gavreto is an oral precision therapy targeting RET alterations, including fusions and mutations, regardless of the tissue of origin. Additionally, the US FDA has granted BT designation for RET fusion+ NSCLC and RET mutation+ MTC and PR for advanced or m-RET-mutant MTC and RET fusion+ thyroid cancer to the therapy with its anticipated PDUFA date as 28 Feb, 2021

AstraZeneca Expanded the Development of AZD1222 into P-III Study in the US Across All Adult Age Groups

Date- Sept 01, 2020

Product- AZD1222

  • AstraZeneca has expanded the development of AZD1222 into P-III D8110C00001 study to assess it safety, efficacy and immunogenicity. BARDA has funded the P-III study to accelerate the development of the vaccine
  • The P-III D8110C00001 study involves assessing of AZD1222 vs PBO for the prevention of COVID-19, in up to 30,000 participants aged ≥ 18yrs. in a ratio (2:1) across ~100 trial centers in and outside the US. Participants are being randomized to receive two doses of either AZD1222 or a saline control, 4wks. apart, with twice as many participants receiving the potential vaccine than the saline control
  • The company is evaluating the AZD1222 globally with late-stage clinical trials ongoing in the UK, Brazil, and South Africa, while the trials are planned to start in Japan and Russia

GSK and VIR Biotechnology Initiated P-II/III COMET-ICE Study of VIR-7831 Against COVID-19

Date- Sept 01, 2020

Product- VIR-7831

  • The first patient has been dosed last week in a P-II/III COMET-ICE study with VIR-7831 for the early treatment of COVID-19 in patients who are at high risk of hospitalization
  • The study will enroll ~ 1,300 patients globally who have early symptomatic infection. The P-II/III study comprises of two parts: The Lead-In phase will assess the safety and tolerability of VIR-7831 (IV, 500mg) vs PBO over a 14-day period in non-hospitalized patients and aims to recruit 20 patients across the US
  • Following this initial safety assessment, the Expansion phase will assess the safety and efficacy VIR-7831 (IV) vs PBO in ~1,300 non-hospitalized participants globally. The company expects the results in Q1’21 and early access to the Ab treatment in H1’21

World’s First App-Based Nicotine Addiction Treatment Received the MHLW’s Approval in Japan

Date – Aug 31, 2020

Product – CureApp

  • On Aug 21, 2020, CureApp receive MHLW’s approval for the manufacturing and sale of Asia’s first therapeutics app, the “CureApp SC Nicotine Addiction Treatment App and CO Checker’’. The company plans to receive insurance reimbursement and release CureApp SC in FY2020
  • CureApp SC is a prescription medical device designed to aid patients receiving outpatient smoking cessation treatment and supports patients to quit smoking in a home setting. The product consists of three components – a patient app, a doctor app, and a portable CO Checker
  • The patient app can provide personalized guidance and is used in tandem with the portable CO Checker, allowing patients to accurately measure the concentration of CO in their breath at home. The patient’s condition obtained from the patient app and the CO Checker will be shared with doctors via the doctor app

GSK’s Blenrep (belantamab mafodotin) Received EC’s Approval for R/R Multiple Myeloma

Date – Aug 27, 2020

Product – Blenrep (belantamab mafodotin-blmf)

  • The EC’s approval is based on DREAMM-2 study assessing Blenrep (2.5/ 3.4 mg/kg, q3w) as monothx. in adult patients prior treated with 4 therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 mAb, and who have demonstrated disease progression on the last therapy
  • The data demonstrated that Blenrep (2.5 mg/kg dose, q3w) resulted in 32% ORR, mDoR (11mos.) & mOS (13.7mos.) while the safety and tolerability profile is consistent with previous data of the therapy
  • Blenrep is a BCMA mAb conjugated to the cytotoxic agent auristatin F via a non-cleavable linker and has received EMA’s PRIME designation in 2017

Novartis’ Kesimpta (ofatumumab) Received the US FDA’s Approval as the First Self-Administered Therapy for Relapsing Multiple Sclerosis

Date – Aug 21, 2020

Product – Kesimpta (ofatumumab)

  • The approval is based on P-III ASCLEPIOS I & II studies assessing Kesimpta (20mg, monthly, SC) vs teriflunomide (14mg, qd) in 1,882 patients aged 18-55yrs. with RMS with an EDSS b/w 0 and 5.5 across 37 countries. Additionally, P-II APLIOS study determine the bioequivalence of subcutaneous delivery of Kesimpta via a prefilled syringe and a Sensoready pen in patients with RMS
  • ASCLEPIOS I & II studies results: reduction in ARR 51% & 59% (0.11 vs 0.22 & (0.10 vs 0.25), 34% reduction in 3mos CDP, reduction in number of Gd+ T1 (98% & 94%) and new/ enlarging T2 lesions (82% & 85%) respectively
  • In a post hoc analysis, Kesimpta may halt new disease activity in RMS with 47.0% & 7.8% of patients achieved (NEDA-3) within (0–12mos.) and (12–24 mos.) of treatment, respectively. The therapy is expected to be available in the US in early Sept’2020 along with its anticipated EU approval in Q2’21

Johnson & Johnson Acquired Momenta Pharmaceuticals for $6.5B

Date – Aug 19, 2020

Deal Value – ~$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 key innovation hub. Nipocalimab provides an opportunity for Janssen to deliver transformative treatments in autoantibody-driven autoimmune diseases

Sanofi Acquired Principia Biopharma for ~$3.68B

Date – Aug 17, 2020

Deal Value – ~$3.6B

  • Sanofi to acquire Principia Biopharma in all stock transaction, at $100/share making total deal value ~$3.68B in cash. The transaction is expected to be completed in Q4’20
  • The focus of the acquisition is to strengthen its R&D areas of autoimmune and allergic diseases with the expansion of SAR442168 development program into CNS disorders. Additionally, the deal also adds rilzabrutinib to Sanofi’s portfolio of immunology and inflammation indications
  • The Principia’s BTK inhibitor ‘168 is developed using its Tailored Covalency platform and was evaluated in P-IIb study for MS leading reduction of 85% Gd-enhancing T1 hyperintense lesions vs PBO. In 2017, Sanofi signed exclusive WW license agreement with Principia to develop and commercialize BTK inhibitor ‘168 in MS and other CNS diseases

Zydus Launched Cheapest Version of Remdesivir at $37.41 per Vial in India

Date – Aug 13, 2020

Product – Remdesivir

  • 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 patients

Biogen Signed an Agreement with Denali on LRRK2 Program for Parkinson’s Disease Worth ~$2.125B

Date – Aug 07, 2020

Deal Value – ~$2.125B

  • Denali to receive $560M up front, $465M as equity investment at a price of $34.94/ share, representing 11.2% of Denali’s pro-forma outstanding stock along with $1.125B as milestones.
  • The two companies will codevelop Denali’ LRRK2 inhibitor for PD and co-commercialize it the US and China while Biogen have the right to commercialize the therapy in other territories and will pay royalties for the same. Biogen & Denali will share global development cost (60% & 40%) with equal share in profit and loss in the US and in China (60% & 40%) respectively
  • Denali’ LRRK2 inhibitor (DNL151) has been progressed into late stage clinical studies expected to commence in 2021. Additionally, Biogen to receive exclusive option rights to two programs for neurodegenerative diseases utilizing Denali’s TV technology platform, including for amyloid beta + right of first negotiation for two additional unnamed TV platform programs

Siemens Healthineers Acquired Varian for $16.4B

Date – Aug 04, 2020

Deal Value – ~$16.4B

  • Siemens Healthineers to acquire Varian in all-cash transaction, at a price of $177.50/ share with 42% to the 30-day volume weighted average closing price of Varian’s common stock as of July 31, 2020, making a total deal value ~$16.4B
  • The transaction is expected to be closed in H1’21. The combined company will offer an integrated platform of end-to-end oncology solutions to addressing the complete continuum of cancer care, from screening and diagnosis to care delivery and post-treatment survivorship
  • Varian and Siemens Healthineers will lead the digital transformation of oncology healthcare, enabling more efficient diagnosis, increased treatment quality and access, personalized precision cancer care, and improved outcomes for millions of patients worldwide

Sanofi and GSK Received $2.1B from the US Government to Supply 100M Doses of COVID-19 Vaccine

Date – Aug 03, 2020

Value – $2.1B

  • The US government will provide ~$2.1B to support the development of the vaccine, including clinical trials with some amount to be used for ramping up the manufacturing and delivery of an initial 100M dose of the vaccine
  • The US government has an option to supply an additional 500M dose and helps the government’s Operation Warp Speed goals for providing millions of doses of a safe and effective COVID-19 vaccine
  • Additionally, the companies are in discussion with the EC for the supply of up to 300M doses of a COVID-19 vaccine. Both the companies are committed to making their COVID-19 vaccine affordable and available globally

Roche’s Actemra/RoActemra (tocilizumab) Failed to Meet the Primary Endpoint in P-III COVACTA Study for Patients with COVID-19 Associated Pneumonia

Date – Jul 29, 2020

Product – Actemra/RoActemra (tocilizumab)

  • The P-III COVACTA study involves assessing of Actemra/RoActemra (IV) + SOC vs PBO + SOC in adult patients hospitalized with severe COVID-19 associated pneumonia. Patients will be followed for 60 days post randomization
  • The study did not meet its 1EPs i.e. improvement in clinical status and 2EPs i.e. difference in patient mortality @4wks. (19.7% vs 19.4%); median time to discharge (20 vs 28days); rate of infection (38.3% vs 40.6%); rates of serious infections (21.0% vs 25.9%)
  • Actemra/RoActemra was the first approved anti-IL-6 receptor biologic available in both in IV/ SC formulations for the treatment of adult patients with moderate-to-severe active RA. Roche will continue the clinical study of Actemra in other treatment settings including in combination with an antiviral

Roche and UCB Collaborated to Develop UCB0107 for Alzheimer’s Disease

Date- Jul 29, 2020

Deal Value- ~$2B+

  • UCB to receive $120M and is eligible to receive $2B as cost reimbursement, development and commercial milestones as well as royalties on sales of the therapies, if Roche proceed the clinical development. Roche to get an exclusive license to develop and commercialize UCB0107 for AD
  • UCB to fund and perform a POC study in AD and, upon availability of the results of that study while Roche has the right to progress with the development or return full rights back to UCB
  • UCB0107 is an IgG4 mAb targeting a central Tau epitope, being developed to block/reduce the spread of Tau pathology. UCB continues to develop UCB0107 in PSP, with anticipated initiation of P-III study in Q2’21

AstraZeneca Signed an Agreement with Daichii Sankyo to Develop and Commercialize DS-1062 Worth Up to $6B

Date – Jul 27, 2020

Deal Value – ~$6B

  • Daichii Sankyo to receive $1B as upfront of which $350M is due upon execution, $325M after 12mos. and $325M after 24 mos., ~$5B as contingent payment including $1B as regulatory milestones, and $4B as commercial milestones, making a total deal value up to ~6B
  • The companies will jointly develop and commercialize DS-1062 globally and share equal development & commercialization costs, except in Japan where Daiichi Sankyo will maintain exclusive rights and manufacture and supply DS-1062
  • Daiichi Sankyo is expected to book sales in US, certain EU countries, and other markets where the company has affiliates while AstraZeneca is expected to book sales in other markets globally, including China, Australia, Canada, and Russia. DS-1062 is a TROP2 directed DXd ADC, currently in P-I study for NSCLC and TNBC

Sanofi Signed an Agreement with Kymera to Advance Novel Protein Degrader Therapies Worth Up to $2.1B

Date – Jul 10, 2020

Deal Value – ~$2.1B

  • Kymera to receive $150M up front, $2B as development, regulatory and commercial milestones along with royalties on sales of therapies. Additionally, the company has an option to develop and commercialize the two programs in the US while retaining global rights to its IRAK4 program in oncology indications.
  • Sanofi will get a global right to develop and commercialize protein degrader therapies targeting IRAK4 in patients with immune-inflammatory diseases and a second undisclosed preclinical program
  • Kymera will advance the IRAK4 program through P-I study, afterwards Sanofi will be further responsible for its development and will lead all clinical development activities for the second program. IRAK4 is a key protein involved in inflammation mediated by the activation of TLRs and IL-1Rs

Bausch Health Spun off its Eye Health Business

Date – July 08, 2020

Product – N/A

  • Bausch Health spin off its leading eye health business into an independent publicly traded company under the name Bausch + Lomb. The spinoff is expected to be completed in H1’21
  • The spinoff will lead to the formation of two separate companies that include an eye-health company built on the iconic Bausch + Lomb brand and a diversified company with leading positions in gastroenterology, aesthetics/dermatology, neurology, and international pharmaceuticals
  • Bausch + Lomb will consist of Bausch Health’s global vision care, surgical, consumer and ophthalmic Rx businesses which had generated $3.7B revenue in 2019. The other company would comprise brands across the Salix, International Rx, neurology, and medical dermatology businesses that generated a revenue of ~$4.9B in 2019

Roche Signed a ~$1B Agreement with Blueprint Medicines for its Precision Therapy to Treat Patients with RET-Altered Cancer Indications

Date – Jul 07, 2020

Deal Value – ~$1B

  • Blueprint Medicine to receive $675M as up front, $100M as equity investment and is eligible to receive up to $927M as development, regulatory and commercial milestones along with royalties on sales of therapy outside the US
  • Roche to get an exclusive right to co-develop globally and commercialize pralsetinib outside the US, excluding Greater China. In the US, Roche will get co-commercialization rights to pralsetinib. The companies will share global development expenses based on pre-specified cost-sharing percentages and equally share profits and losses in the US
  • Pralsetinib (qd, PO) is precision therapy for the treatment of patients with RET-altered NSCLC, MTC and other types of thyroid cancer, and solid tumors and has demonstrated tumour-agnostic potential with its PDUFA date as Nov 23, 2020

Merck KGaA and Pfizer’s Bavencio (avelumab) Received the US FDA’s Approval as a 1L Treatment for Locally Advanced or Metastatic Urothelial Carcinoma

Date – Jul 01, 2020

Product – Bavencio (avelumab)

  • The approval is based on P-III JAVELIN Bladder 100 study assessing Bavencio (10 mg/kg, IV infusion, q2w) + BSC vs BSC as monothx. in 700 patients with LA/ m-UC whose disease had not progressed after 1L platinum-based induction CT as per RECIST v1.1
  • Results: median OS (7.1 vs 21.4mos.); improvement in OS represents a 31% reduction in the risk of death in the overall population, in PD-L1+ patients (44% reduction in risk of death), in an exploratory analysis of patients with PD L1 negative tumors, OS hazard ratio (0.85)
  • Priority review of the therapy was completed under FDA’s Real-Time Oncology Review (RTOR) pilot program, following the receipt of BT designation. In 2017, the US FDA approved the therapy under the accelerated approval program and now converted it to a full approval

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

Insights+: The US FDA New Drug Approvals in September 2020

The US FDA has approved 6 NDAs in Sept 2020, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 85 novel products so far in 2020, including 6 in Sept 2020. Additionally, last year in 2019, the US FDA has approved 48 novel products. We have compiled a list of a total of 6 new drugs approved by the US FDA in Sept 2020.

1. Athena Bioscience’s Qdolo (tramadol hydrochloride) Received the US FDA’s NDA Approval for Oral Solution

Published: Sept 01, 2020 | Tags: Athena Bioscience, QDOLO, tramadol hydrochloride, Receives, U.S. FDA, Approval, NDA, Oral, Solution

  • Athena Biosciences announced that the US FDA has approved Qdolo (tramadol hydrochloride) oral solution 5mg/1mL C-IV
  • The most common AE’s (≥15.0%) observed in patients were dizziness/vertigo, nausea, constipation, headache, somnolence, vomiting, and pruritus
  • Qdolo is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. It will be available at the chain, independent, and specialty pharmacies

2. BMS’ Onureg (azacitidine) Received the US FDA’s Approval as Continued Treatment for Acute Myeloid Leukemia

Published: Sept 01, 2020 | Tags: Azacitidine, Acute Myeloid Leukemia, Approval, BMS, Continued Treatment, FDA, Onureg, US

  • The approval is based on P-III QUAZAR AML-001 study assessing Onureg (300 mg, PO) vs PBO  for 14 days of a 28-day cycle + BSC in a ratio (1:1) in 472 patients aged ≥55yrs. with AML and had achieved CR or Cri following intensive induction CT and cannot proceed with intensive curative therapy including HSCT
  • The P-III QUAZAR AML-001 study results: m-OS (24.7 vs 14.8mos.); m-DOR (12 vs 6 cycles). Additionally, the therapy has received the US FDA’s PR designation while EMA validates its MAA in May’2020
  • Onureg (CC-486) is an oral hypomethylating agent that incorporates into DNA and RNA and carries out hypomethylation of DNA, as well as direct cytotoxicity to abnormal hematopoietic cells in the bone marrow

3. RadioMedix and Curium Detectnet (copper Cu 64 dotatate injection) Received the US FDA’s Approval for Positive Neuroendocrine Tumors (NETs)

Published: Sept 03, 2020 | Tags: RadioMedix, Curium, Detectnet, copper Cu 64 dotatate injection, US FDA Approval, Positive Neuroendocrine Tumors (NETs)

  • The approval is based on P-lll study which involves the assessing of Detectnet (copper Cu 64 dotatate injection) in Neuroendocrine Tumors (NETs) patients. Curium expects to launch detectnet immediately with doses available through various nuclear pharmacies
  • The P-III results demonstrated that the clinical sensitivity and specificity provide a great aid to clinicians in develop accurate treatment approach for their NET patients. Additionally, the 12.7-hrs. half-life allows detectnet to be produced centrally and shipped to sites
  • Detectnet is a positron emission tomography (PET) agent indicated for the localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult patients

4. Genentech’ Gavreto (pralsetinib) Received the US FDA’s Approval Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

Published: Sept 04, 2020 | Tags: Pralsetinib, Adults, Approval, FDA, Fusion-Positive, Gavreto, Genentech, Metastatic Non-Small Cell Lung Cancer, Rearranged, Transfection, US

  • The approval is based on P-I/II ARROW study assessing Gavreto (400mg, qd) in RET fusion-positive NSCLC patients with or without prior therapy, and regardless of RET fusion partner or CNS involvement. The study also involves patients with RET-MTC, RET fusion-positive thyroid cancer, and other RET-altered solid tumors
  • Results: ORR (57%) and CR rate (5.7%) in 87 NSCLC patients prior to treated with Pt. based CT, m-DOR was not reached, in 27 treatment-naïve NSCLC patients, ORR (70%); CR rate (11%). Gavreto is now the 6th FDA-approved medicine in Genentech’s portfolio for lung cancer and will co-commercialize by Genentech and Blueprint Medicines in the US
  • Gavreto is an oral precision therapy targeting RET alterations, including fusions and mutations, regardless of the tissue of origin. Additionally, the US FDA has granted BT designation for RET fusion+ NSCLC and RET mutation+ MTC and PR designation for advanced or m-RET-mutant MTC and RET fusion+ thyroid cancer to the therapy with its anticipated PDUFA date as Feb 28, 2021

5. Pfizer’s Xeljanz (tofacitinib) Received the US FDA’s Approval for Active Polyarticular Course Juvenile Idiopathic Arthritis

Published: Sept 28, 2020 | Tags: Active Polyarticular Course Juvenile Idiopathic Arthritis, Approval, FDA, Tofacitinib, US, Xeljanz

  • The approval is based on P-III study including 2 phases assessing tofacitinib (5mg or 1mg/mL oral solution, bid) for 44wks. The 2phases includes an 18 wks. open-label, run-in phase study of 225 patients and a 26wks. PBO controlled withdrawal study of 173 patients
  • Results: the study met its 1EP showing ACR30 response at the end of the run-in phase; the occurrence of disease flare in patients (31% vs 55%) @44wks. The approval makes Xeljanz the first and only JAK inhibitor approved in the US for pcJIA
  • The US FDA has approved the two formulations of Xeljanz (a tablet and an oral solution) and are dosed based on weight. The oral solution is expected to be available by the end of Q1’21 while the tablets (5mg) are available instantly

6. Eton Pharmaceutical’s Alkindi Sprinkle (hydrocortisone) Received the US FDA’s Approval as Replacement Therapy in Pediatric Patients

Published: Sept 29, 2020 | Tags: Eton Pharmaceuticals, Alkindi Sprinkle, hydrocortisone, US FDA Approval, Adrenocortical Insufficiency

  • The approval is based on 6 clinical studies, including the 1st and only interventional P-lll study which involves the assessing of Alkindi Sprinkle (hydrocortisone) for Pediatric AI in neonates to children under 8 yrs. of age
  • Eton expects Alkindi Sprinkle to be commercially available in the Q4’ 2020 and it will be available in four strengths: 0.5mg, 1mg, 2mg, and 5mg, to give greater dosing flexibility to clinicians
  • Alkindi Sprinkle is the 1st and only FDA-approved granular hydrocortisone formulation for the treatment of adrenocortical insufficiency specifically designed for use in children

Related Post: Insights+: The US FDA New Drug Approvals in August 2020

The post Insights+: The US FDA New Drug Approvals in September 2020 first appeared on PharmaShots.

Genentech Collaborates with Imbio to Develop Imaging Diagnostics for Lung Diseases

Shots:

  • The agreement leverages Imbio’s technical, regulatory & commercial expertise to build medical imaging AI technology for use in research, clinical trials & clinical practice
  • The focus of the agreement is to develop quantitative imaging diagnostics for lung diseases and to bring unique solutions for pulmonary imaging. The collaboration integrates Imbio’s expertise in imaging biomarkers with Genentech’s pulmonary disease expertise for enhancing drug development and delivering more personalized healthcare
  • Imbio will continue to develop & market its portfolio of quantitative imaging algorithms for lung & cardiothoracic diseases apart from the collaboration

    Click here ­to­ read full press release/ article | Ref: PR Newswire | Image: UT Health

The post Genentech Collaborates with Imbio to Develop Imaging Diagnostics for Lung Diseases first appeared on PharmaShots.

FDA’s Ok to Roche’s Oral SMA Therapy; Roche’s Etrolizumab Mixed Results in Ulcerative Colitis; Secura receives rights to Copiktra from Verastem

Roche Set to Compete With Biogen and Novartis in the SMA Market With its First Oral Therapy 

Spinal Muscular Atrophy Market

The US FDA has recommended the use of Evrysdi (risdiplam), a candidate of Genentech, a Roche company, for spinal muscular atrophy (SMA), an inherited neuromuscular disease resulting in muscle atrophy, in adults and children two months of age and older.

Evrysdi is orally administered and was evaluated in a broad clinical trial program with patients range from birth to 60 years old, including difficult-to-treat populations whose disease had progressed. It is a survival motor neuron-2 (SMN-2) splicing modifier, designed to increase and sustain SMN protein levels throughout the central nervous system and peripheral tissues. It is under investigation in two clinical studies for Types 1, 2, and 3 SMA. The drug showed improvement in both the trials. The drug improved survival without permanent ventilation at 12 and 23 months compared to natural history.

Before Evrysdi, Biogen’s Spinraza and Novartis’ Zolgensma are already approved and commercially available in the Spinal muscular atrophy market; however, it’s comparatively lower price and oral administration route will benefit the drug to expand in the SMA market. 

Roche’s Gut Disease Drug, Etrolizumab Presents Muddled Results in Ulcerative Colitis Trials 

Ulcerative Colitis Market

Genentech has been running a major clinical trial program, studying its first-ever investigational therapy, Etrolizumab, to treat Ulcerative Colitis. The results from the trials evaluating Etrolizumab as induction therapy and as maintenance therapy posted by the company appeared mixed.

The results from the Phase III HIBISCUS I induction study, etrolizumab met the primary endpoint in patients without prior anti-tumor necrosis factor (anti-TNF) treatment; however, in the HIBISCUS II induction study, which also included people without prior anti-TNF treatment, etrolizumab failed to meet its primary endpoint.

In the HICKORY study, in people with prior anti-TNF treatment, etrolizumab managed to meet the primary endpoint at induction, but at maintenance, it failed. In the LAUREL maintenance study in people without previous anti-TNF treatment also etrolizumab was unable to meet its primary endpoint.

Etrolizumab is an antibody engineered to block two members of a family of proteins called integrins to stop immune overreaction by preventing the WBCs to enter into the gut.  

Secura Bio Secures the Global Commercial and Development Rights to Copiktra from Verastem

Verastem, a biopharma company advancing cancer treatments, has signed a definitive agreement with Secura Bio to sell its global commercial and development rights to COPIKTRA (duvelisib). Moreover, Secura also has received rights to Verastem’s oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first FDA-approved dual inhibitor of PI3K-delta and PI3K-gamma. 

Oncology Market

Under the terms of the agreement, Verastem will receive an up-front amount of USD 70 Million, with a total deal value of up to USD 311 Million and royalties on sales. For smoother transactions, Secura has taken a USD 70 Million financing by  Athyrium Capital Management. Secura will fund the ongoing trials and projects of Verastem to develop VS-6766 and Defactinib in Low-Grade Serous Ovarian Cancer and KRAS Mutant Non-Small Cell Lung Cancer at least until 2024. 

Secura plans to reinforce the development of Copiktra in the treatment of T-cell lymphomas, and exploit PI3K and HDAC inhibitors for additional value in the trial outcomes. 

The post FDA’s Ok to Roche’s Oral SMA Therapy; Roche’s Etrolizumab Mixed Results in Ulcerative Colitis; Secura receives rights to Copiktra from Verastem appeared first on DelveInsight Business Research.

Genentech Reports Results of Port Delivery System with Ranibizumab in P-III Archway Study for Neovascular Age-Related Macular Degeneration

Shots:

  • The P-III Archway study involves assessing of PDS with ranibizumab, refilled @6mos. at fixed intervals, vs ranibizumab (0.5mg, monthly IVT) in 418 patients with nAMD, prior treated with VEGF therapy
  • Results: 98.4% of PDS patients were able to go 6mos. without needing additional treatment and achieved vision outcomes equivalent to patients receiving ranibizumab (0.5mg, monthly IVT), PDS demonstrated non-inferior and equivalent visual acuity outcomes with a favorable benefit-risk profile
  • PDS is a permanent refillable eye implant that continuously delivers a customized formulation of ranibizumab over a period of mos., potentially reducing the treatment burden associated with frequent eye injections

Click here to read full press release/ article | Ref: Genentech | Image: Twitter




Roche, PicnicHealth start RWD partnership with multiple sclerosis focus

The companies will use a combination of more than seven years of medical record data with five years of prospective data on 5,000 MS patients, including real-world outcomes data and MRI images. Other disease areas to be explored include hematology and rare diseases.