This week Pfizer PFE signed a letter of intent to jointly develop BioNTech’s potential vaccine for the coronavirus disease, COVID-19. Meanwhile, Roche RHHBY and Regeneron/Sanofi SNY announced plans to study their IL-6 inhibitors, Actemra and Kevzara, respectively, to treat severe COVID-19 infection.
Recap of the Week’s Most Important Stories:
Regeneron/Sanofi & Roche to Evaluate IL-6 Inhibitors for Severe Coronavirus Infection: Regeneron and Sanofi announced the initiation of a U.S. based phase II/III study to evaluate their rheumatoid arthritis (RA) drug, Kevzara, to treat patients hospitalized with severe infection due to COVID-19. While Regeneron will lead U.S. studies, Sanofi will take care of the ex-U.S. studies, which will be initiated in the coming weeks. Kevzara is an anti-interleukin (IL)-6 receptor monoclonal antibody and the companies believe that in critically-ill COVID-19 patients, the IL-6 pathway may play an important role in driving the overactive inflammatory response in the lungs and emerge as a treatment option.
Roche also said that it is working with the FDA to initiate a phase III study to evaluate its IL-6 inhibitor, Actemra/RoActemra to treat hospitalized patients with severe COVID-19 pneumonia. Actemra is also presently approved to treat RA. Roche is conducting the study in collaboration with BARDA. The study will compare Actemra/RoActemra plus standard of care (SOC) to placebo plus SOC. The phase III study is expected to begin enrolling patients in April. Roche expects to enroll 330 patients in the study globally, including the United States. Meanwhile, the FDA, last week, granted Emergency Use Authorization to Roche’s cobas SARS-CoV-2 test to detect the virus.
Pfizer to Co-Develop BioNTech’s Potential COVID-19 Vaccine: Pfizer signed a letter of intent to co-develop Germany-based biotech BioNTech’smRNA-based vaccine candidate BNT162 to prevent COVID-19. BNT162 is presently in pre-clinical testing and is expected to enter clinical studies in April. The companies are already developing an mRNA-based influenza vaccine, per a deal signed in 2018.
Meanwhile, Pfizer and partner Merck KGaA announced that they are terminating a late-stage head and neck cancer study on their drug Bavencio (avelumab). The decision to terminate was taken on the recommendation of an independent Data Monitoring Committee (DMC) as the study was unlikely to show a statistically significant improvement in the primary endpoint of progression-free survival (PFS).
Pfizer also announced top-line results from one of the three phase III study on its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate. The study evaluated the candidate for the prevention of invasive disease and pneumococcal pneumonia in healthy adults 18 years or older. 20vPnC includes all the 13 serotypes contained in Pfizer’s popular 13-valent pneumococcal conjugate vaccine, Prevnar 13 along with seven additional serotypes. The primary immunogenicity objective of the study was to demonstrate the non-inferiority for the 20 serotypes in 20vPnC in adults 60 years of age and older at one month after vaccination compared to licensed pneumococcal vaccines. The primary objective was met for all serotypes in common with licensed Prevnar 13 and six of the seven additional serotypes. However, one of the new seven serotypes failed to show non inferiority to licensed vaccines by a small margin. The company expects to file a NDA for the vaccine candidate this month.
Pfizer also announced that a phase III study evaluating two doses of its investigational JAK inhibitor, abrocitinib, in patients with moderate-to-severe atopic dermatitis met its co-primary endpoints. Statistically higher percentage of patients receiving abrocitinib witnessed improvement in clear skin from baseline compared to placebo.
Breakthrough Therapy Tag for Lilly/Incyte’sOlumiant for Alopecia Areata: The FDA granted breakthrough therapy status to Lilly LLY/Incyte’s drug Olumiant (baricitinib) for the treatment of alopecia areata (AA), an autoimmune disorder that can cause unpredictable hair loss on scalp and other body parts. Olumiant is currently being evaluated in a phase II/III (BRAVE-AA1) as well as a phase III (BRAVE-AA2) study for the indication. Meanwhile, Olumiant is marketed for the treatment of rheumatoid arthritis in several countries. It is under review in Europe and Japan for atopic dermatitis and will be filed for the same in the United States later in 2020. It is also being studied in phase III studies for systemic lupus erythematosus.
Merck’s Gefapixant Succeeds in Pivotal Cough Studies: Merck MRK announced top-line data from two phase III pivotal studies evaluating gefapixant, its investigational treatment for refractory or unexplained chronic cough. The data from the ongoing studies showed that gefapixant (45 mg twice daily) led to statistically significant decrease in 24-hour coughs per hour compared to placebo at week 12 and 24, thereby meeting the primary efficacy endpoints of the studies. However, the arm evaluating the 15 mg twice daily dose did not meet the primary efficacy endpoint in either of the two studies.
J&J Files NDA for Ponesimod in United States: J&J JNJ submitted new drug application (NDA) in the United States, seeking approval of its pipeline candidate ponesimod for treating adults with relapsing forms of multiple sclerosis (RMS). A marketing application seeking approval of ponesimod in Europe was filed earlier this month. The regulatory filings were based on data from the head-to-head OPTIMUM phase III study comparing ponesimod to Sanofi’s MS drug, Aubagio.
Novo Nordisk Halts Studies on Haemophilia Candidate: Novo Nordisk NVO paused three (two phase III and one phase II) ongoing studies investigating its anti-TFPI mAB, concizumab in hemophilia A and B patients with or without inhibitors. The decision was taken due to the occurrence of non-fatal thrombotic events in three patients in the phase III studies. While the company will not recruit any additional patients in the studies, it will also cease further treatment of patients already enrolled in the studies. Novo Nordisk and an independent Data Monitoring Committee are evaluating all available data to decide whether to continue the studies.
The NYSE ARCA Pharmaceutical Index declined 1.9% in the last five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here is how the seven major stocks performed in the last five trading sessions.
Last week, Lilly recorded the highest increase (5.6%) while Glaxo declined the most (7.8%).
In the past six months, Lilly has risen the most (16.6%) while Glaxo declined the most (19.7%).
(See the last pharma stock roundup here: ABBV, LLY Coronavirus Product Development Efforts, FDA Updates)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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