Pharma Stock Roundup: AZN COVID-19 Vaccine Interim Data, PFE Emergency Use Appeal

This week, AstraZeneca AZN announced that its COVID-19 vaccine candidate achieved an average efficacy rate of 70% in first interim analysis of its phase III study. Meanwhile, Pfizer PFE and its partner BioNTech submitted their request for Emergency Use Authorization (“EUA”) to the FDA for their mRNA-based vaccine candidate in the United States. Merck MRK announced a deal to buy private biotech, OncoImmune, which will add a late-stage COVID-19 treatment to its portfolio.

Recap of the Week’s Most Important Stories

AstraZeneca’s COVID-19 Vaccine Effective: Interim data from late-stage studies in the UK and Brazil on AstraZeneca vaccine candidate, AZD1222 showed that the candidate was, on an average, about 70% effective in preventing COVID-19. One dosing regimen (n=2,741) given as a half dose, followed by a full dose at least one month apart demonstrated efficacy of 90%. Another regimen (n=8,895), given as two full doses at least one month apart, showed an efficacy of 62%, bringing the average efficacy rate at 70%. The efficacy rate was less than 95% and 94.5% announced by rival vaccine makers Pfizer/BioNTech and Moderna, respectively.

AstraZeneca said that protection from COVID-19 occurred 14 days or more after receiving two vaccine shots.AstraZeneca’s vaccine can be transported and stored at normal refrigerator temperatures (2°-8°C) for at least six months.

Meanwhile, the FDA approved a new dosing regimen for AstraZeneca’s key cancer drug, Imfinzi for the approved indications of unresectable, stage III non-small cell lung cancer (NSCLC) after chemoradiation therapy and previously treated advanced bladder cancer. Following the approval, a 1,500mg fixed dose of Imfinzi can now be administered every four weeks in patients weighing above 30kg as an alternative to weight-based dosing of 10mg/kg every two weeks.

Pfizer Seeks FDA’s Emergency Use Tag for COVID-19 Vaccine: Pfizer & BioNTech submitted a request to the FDA to grant emergency use authorization (EUA) to their mRNA-based coronavirus vaccine candidate, BNT162b2. Pfizer believes it can start vaccinating high-risk populations by the end of December if granted EUA. Final data from a phase III study on BNT162b2, announced last week, showed that the candidate was 95% effective in preventing COVID-19. Pfizer plans to manufacture up to 50 million doses by the end of this year, if approval is received, and potentially up to 1.3 billion doses by the end of 2021.

Meanwhile Pfizer began patient dosing in a phase III study on anti-TFPI investigational therapy, marstacimab, for people with severe hemophilia A and B with or without inhibitors

Merck Strengthens COVID-19 Portfolio with OncoImmune Deal: Merck announced a deal to buy private biotech OncoImmune, which will add CD24Fc, a candidate in phase III studies for the treatment of patients with severe and critical COVID-19, to its portfolio. For the deal, Merck is making an upfront payment of $425 million in cash. Meanwhile, CD24Fc is also being evaluated in a pivotal phase III study for prophylaxis of graft versus host disease.

Meanwhile, Merck has filed applications to the FDA and European Medicines Agency for licensure of V114, its investigational 15-valent pneumococcal conjugate vaccine.

EU Approves Sanofi’s Meningococcal Vaccine: The European Commission granted approval to Sanofi’s SNY MenQuadfi, a meningococcal vaccine candidate for the prevention of meningococcal meningitis in patients 12 months of age and older.  The approval was based on data from seven pivotal phase II and III studies.The vaccine was approved in the United States in April this year

Glaxo’s Maternal RSV Vaccine Enters Phase III: Glaxo GSK began patient dosing in a phase III study— GRACE — on its maternal respiratory syncytial virus (RSV) vaccine candidate. Glaxo is developing vaccine against RSV for pediatric patients, pregnant women and older adults. The study on RSV vaccine for pregnant women will evaluate the candidate’s safety and efficacy for pregnant mothers and infants. A phase III study on older adult’s RSV candidate is expected to begin in the coming months while for pediatric population, a phase I/II study is ongoing. Currently no vaccine is available for RSV.

FDA Approves Roche’s Influenza Drug for Expanded Use: The FDA approved Roche’s RHHBY influenza medicine, Xofluza to prevent influenzain those who have had contact with an infected person (post-exposure prophylaxis). Presently, Xofluza is approved for the treatment of uncomplicated influenza in patients aged 12 years and above

The NYSE ARCA Pharmaceutical Index rose 0.2% in the last five trading sessions.

Large Cap Pharmaceuticals Industry 5YR % Return

Large Cap Pharmaceuticals Industry 5YR % Return

Large Cap Pharmaceuticals Industry 5YR % Return

Here’s how the eight major stocks performed in the last five trading sessions.

While AbbVie ABBV recorded the maximum increase (4.6%), AstraZeneca declined the most (2.6%).

In the past six months, while AbbVie recorded the maximum increase (15.7%), Roche declined the most (6%).

(See the last pharma stock roundup here: PFE COVID-19 Vaccine Final Analysis, FDA Updates & More)

What's Next in the Pharma World?

Watch out for pipeline and regulatory updates next week.

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