This week, Merck MRK, Glaxo GSK and Roche RHHBY made announcements related to their efforts to make vaccines and medicines for COVID-19. Sanofi SNY announced its intention to sell majority of its stake in Regeneron through a registered public offering and share buyback by Regeneron. The FDA granted approvals to Bristol-Myers’ BMY dual immunotherapy, Opdivo + Yervoy for a new lung cancer indication and Sanofi’s Dupixent to treat atopic dermatitis or eczema in kids.
Recap of the Week’s Most Important Stories:
Merck Enters COVID-19 Vaccine/Treatment Development Arena: Merck announced three deals to find new medicines and vaccines to help combat COVID-19. First, Merck announced a deal to acquire Austrian private biotech, Themis, which has a COVID-19 vaccine candidate in preclinical development. Themis developed the candidate using its measles virus vector platform. Second, Merck is buying exclusive worldwide rights to develop and commercialize private biotech Ridgeback Biotherapeutics’ oral antiviral candidate, EIDD-2801, which is being evaluated in early clinical studies to treat COVID-19. Merck will take care of clinical development and regulatory filings of the candidate. Third, Merck signed a collaboration with a non-profit research organization, IAVI to co-develop a vaccine to prevent COVID-19.
Glaxo to Make 1B Doses of its Adjuvanted COVID-19 Vaccine: Glaxo said it plans to produce 1 billion doses of its pandemic vaccine adjuvant next year to support the development of multiple COVID-19 vaccine candidates that are suitable for use with an adjuvant. The pandemic adjuvant can reduce the amount of vaccine protein required per dose, which can result in production of more vaccines. Glaxo has formed several collaborations to make its pandemic adjuvant technology available to partners who are making adjuvanted COVID-19 vaccine candidates.
Meanwhile, the FDA granted priority review designation to Glaxo’s regulatory application seeking approval of its drug Nucala for Hypereosinophilic Syndrome (HES), a rare disease caused by eosinophilic inflammation. Nucala is already marketed for severe eosinophilic asthma and for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA).
Roche Begins Study on Actemra plus Gilead’s Remdesivir in Severe COVID-19 Patients: Roche, in partnership with Gilead, initiated a phase III study to evaluate its drug Actemra/RoActemra plus Gilead’s antiviral remdesivir in hospitalized patients with severe COVID-19 pneumonia. Remdesivir is already being evaluated in phase III studies as a monotherapy for the treatment of COVID-19. Meanwhile, Roche is also evaluating Actemra in a phase III study in hospitalized patients with severe COVID-19 pneumonia. Roche is close to completing enrollment in this study with data expected to be presented this summer.
Sanofi to Exit Most of Its Stake in Regeneron: Sanofi intends to sell most of its stake in Regeneron through a registered public offering and related share repurchase by Regeneron. Sanofi currently holds approximately 23.2 million shares of Regeneron common stock, which represents approximately 20.6% ownership. Sanofi plans to sell a portion of its stake (almost worth $7.3 billion) in Regeneron through a registered public offering. Regeneron will thereafter repurchase its common stock worth $5 billion from Sanofi, following the successful completion of the public offer. Following the completion of public offering and share repurchase, Sanofi will continue to hold approximately 400,000 shares of Regeneron. However, the deal will have no effect on the companies’ ongoing collaboration terms.
Meanwhile, Dupixent’s pivotal phase III study evaluating it in patients 12 years and older with eosinophilic esophagitis (EoE) met both its co-primary endpoints, as well as all key secondary endpoints. In the study, Dupixent dramatically reduced eosinophils in the esophagus and also improved all clinical, anatomic and histologic measures of the disease.
Several Approvals by FDA and EC: The FDA granted approval to Bristol-Myers dual immunotherapy, Opdivo + Yervoy combined with limited chemotherapy as first-line treatment of metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. The FDA approval was based on pre-specified interim data from the phase III CheckMate -9LA study. This marks the second approval of an Opdivo + Yervoy-based combo for the first-line treatment of advanced NSCLC. Last week, the FDA had approved Opdivo + Yervoy as first-line treatment of patients with metastatic NSCLC whose tumors express PD-L1≥1%.
The FDA approved Sanofi/Regeneron’s blockbuster drug, Dupixent to treat children aged 6 to 11 years with moderate-to-severe atopic dermatitis whose disease is notwell controlled on topical prescription medications. Dupixent is already approved to treat moderate-to-severe atopic dermatitis in adults as well as for two other type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis and severe asthma.
The FDA also approved Lilly’s LLY Tauvid (flortaucipir), a diagnostic agent to image tau neurofibrillary tangles in the brain for use in patients being evaluated for Alzheimer's disease.
Meanwhile, the European Commission approved Bristol-Myers’ Zeposia (ozanimod) for treating relapsing remitting multiple sclerosis (RRMS) patients with active disease. With the approval, Zeposia becomes a new first-line treatment option in Europe, which can help address the disease’s hallmark relapses and brain lesions.
New Collaboration Deals for Lilly & AstraZeneca: Lilly and Boehringer Ingelheim announced a collaboration with Duke Clinical Research Institute to conduct a pragmatic study, EMPACT-MI (n~3300) to evaluate Jardiance's effects following an acute myocardial infarction/heart attack. The study will evaluate if Jardiance can improve outcomes and prevent heart failure in adults with and without diabetes who have had an acute myocardial infarction/heart attack. The study will be part of Jardiance’s ENPOWER clinical program.
AstraZeneca AZN signed a deal with ArcherDX, a genomic analysis company, to use the latter’s personalized assay to identify eligible patients for its newly launched global phase III MERMAID-1 study on Imfinzi for patients with resected, early-stage non-small cell lung cancer
The NYSE ARCA Pharmaceutical Index rose 0.67% in the last four trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here is how the nine major stocks performed in the last four trading sessions.
Last week, Merck rose the most (3.2%) while AstraZeneca & AbbVie declined the most (3.2%).
In the past six months, Lilly has risen the most (29%) while Merck declined the most (9.2%).
(See the last pharma stock roundup here: FDA Ok’s Cancer Drugs for New Use, JNJ Stops US Baby Powder Sales)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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