This week, Eli Lilly LLY has applied for the emergency use of its coronavirus antibody candidate and Pfizer PFE/BioNTech has started rolling filing for their COVID-19 vaccine approval in Europe. AstraZeneca AZN resumed its COVID-19 vaccine study in Japan.
Recap of the Week’s Most Important Stories
Lilly Files for EUA of Antibody Candidate, LYCoV555: Lilly applied to the FDA for Emergency Use Authorization (EUA) for its antibody therapy candidate, LYCoV555, as a monotherapy for the treatment of higher-risk patients who have been recently diagnosed with mild-to-moderate COVID-19. The company also released promising data from the combination cohort of the phase II BLAZE-1 study which showed that an antibody combination, LYCoV555 and LY-CoV016, reduced viral load symptoms and COVID-19 related hospitalization and emergency room visits.
The request for EUA was based on this dual therapy data as well data from the monotherapy cohort which was released last month. Lilly will file a separate request for EUA for the combination therapy in November.
Lilly, meanwhile, entered into an agreement with Bill & Melinda Gates Foundation for the supply of its potential COVID-19 antibody therapy for low- and middle-income countries. The deal is part of the foundation’s COVID-19 Therapeutics Accelerator (CTA) philanthropic program, which aims to quickly bring effective COVID-19 medicines to the market. Commercial manufacturing of the candidate will begin at CTA’s reserved manufacturing facility in Denmark from April 2021.
EMA Starts Rolling Review of Pfizer’s Coronavirus Vaccine: Pfizer/BioNTech began rolling submission of their mRNA-based coronavirus vaccine candidate, BNT162b2, to the European Medicines Agency (EMA). The EMA accepted rolling review on the candidate based on available preclinical and clinical data.
As part of the rolling review process, the EMA’s Committee for Medicinal Products for Human Use has begun evaluating the pre-clinical data. After the rolling review process is complete, the final/formal marketing application will be filed once the EMA is satisfied that the submitted data are adequate and demonstrates the vaccine’s efficacy and safety.
Meanwhile, Pfizer along with partner OPKO Health announced favorable top-line data from a phase III study evaluating somatrogon dosed once-weekly in children 3 to <18 years of age with growth hormone deficiency. The study met its primary endpoint by showing improved treatment burden with somatrogon injection compared to somatropin injection (current standard of care) administered once daily, as measured by mean overall Life Interference total score. The efficacy of somatrogon seen in the study demonstrates its potential to reduce lifestyle interference, support patient preference, and improve adherence compared to somatropin.
Meanwhile, Pfizer and partner Sangamo announced initiation of a phase III study evaluating giroctocogene fitelparvovec/SB-525, an investigational gene therapy in patients with severe hemophilia A.
AstraZeneca Re-Starts COVID-19 Vaccine Study in Japan: AstraZeneca resumed the phase I/II clinical study on its COVID-19 vaccine candidate, AZD1222, in Japan following re-start of studies in UK, Brazil, South Africa and India. Last month, AstraZeneca temporarily paused all its global late-stage studies on AZD1222, which it is developing in partnership with Oxford University, as a patient in U.K. suffered an unspecified illness. However, while the international studies have now resumed, the study in the United States remains on hold and the company is in discussion with the FDA to provide the necessary information to re-start the studies.
Glaxo/Vir Biotech’s COVID-19 Antibody Drug Enters Phase III: Glaxo GSK and partner Vir Biotech announced the global expansion to phase III of the COMET-ICE study on their monoclonal antibody, VIR-7831, for the early treatment of COVID-19 in patients who are at high risk of hospitalization. The study continued to phase III on the recommendation of an Independent Data Monitoring Committee based on positive data from the lead in portion of the phase II COMET-ICE study. Initial data from the phase III study are expected by the end of 2020 while results for the primary endpoint are expected in the first quarter of 2021.
The COMET program also includes two other studies, one for the treatment of hospitalised patients and another for the prevention of symptomatic infection. The study is part of a collaboration agreement between Glaxo and Vir Biotechnology signed in April to develop antibody treatments for coronaviruses including SARS-CoV-2.
J&J Agrees to Supply 200M Doses of Coronavirus Vaccine to European Countries: J&J JNJ announced an agreement with the European Commission to supply 200 million doses of its investigational COVID-19 vaccine candidate, following approval, to European countries. The agreement also includes an option for EU member states to secure up to 200 million additional doses.
J&J has begun a large pivotal phase III study to evaluate the safety and efficacy of a single dose of its investigational COVID-19 vaccine candidate, JNJ-78436735, this month. J&J has signed a similar advance supply agreement to provide 100 million doses of its candidate to the U.S. government. J&J has a goal to supply more than one billion doses globally, if the vaccine is approved.
EMA Accepts Sanofi’s Application for Pompe Disease Candidate: The European Medicines Agency accepted Sanofi’s SNY application seeking approval of its investigational enzyme replacement therapy, avalglucosidase alfa, for the treatment of late-onset Pompe disease, for review. The marketing authorization application is based on data from two studies which include both infantile-onset and late-onset Pompe disease patients. The EMA is expected to give its decision in the second half of 2021.
Novo Nordisk Raises 2020 Outlook: Novo Nordisk NVO raised its previously issued sales and operating profit growth outlook for 2020 due to lower-than-anticipated negative impacts from COVID-19. It expects sales growth at constant exchange rate (CER) in the range of 5-8% versus prior expectation in the range of 3-6%. Operating profit growth expectations were raised from 2-5% to 5-8%. The company also issued preliminary third-quarter sales and operating profit growth rate. Novo Nordisk’s sales increased by 7% and operating profit increased by 7%, both at CER, in the third quarter.
The NYSE ARCA Pharmaceutical Index rose 1.13% in the last five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here is how the eight major stocks performed in the last five trading sessions.
In the last five trading sessions, Lilly recorded the maximum increase (6.3%) while Merck declined the most (1.5%).
In the past six months, AstraZeneca has risen the most (21.1%) while Merck declined the most (2.5%).
(See the last pharma stock roundup here: FDA Approves New Uses of PFE, JNJ & GSK’s Drugs)
What's Next in the Pharma World?
Watch out for J&J’s third quarter earnings results and regular pipeline and regulatory updates next week.
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