Merck MRK announced positive top-line results from two late-stage studies in adults evaluating V114, its investigational 15-valent pneumococcal conjugate vaccine, in phase III development for the prevention of pneumococcal disease in adults and children.
The two-phase III studies — PNEU-AGE (V114-019) and PNEU-TRUE (V114-020) — evaluating the safety, tolerability and immunogenicity of V114 met their primary immunogenicity objectives.
PNEU-AGE being conducted in healthy adults 50 years of age or older showed that V114 is non-inferior to the currently available 13-valent pneumococcal conjugate vaccine (PCV13) for the 13 serotypes targeted by both vaccines. Moreover, it was superior for serotypes 22F and 33F, which are targeted by V114 but not PCV13. The study also met the key secondary immunogenicity objective, demonstrating superiority of V114 compared to PCV13 for serotype 3.
The other phase III study, PNEU-TRUE, being conducted in healthy adults 50 years of age or older, showed that V114 met its primary immunogenicity objective demonstrating equivalent immune response across all 15 serotypes for three different lots of V114.
Data from both studies showed that V114 was generally well tolerated, with a safety profile comparable to PCV13 and consistent with that observed in previously reported studies.
The results from these two studies and additional phase III data from the program will form the basis of global regulatory licensure applications. Merck intends to submit application with the FDA before the end of the year.
Pneumococcal serotypes, which are not in the currently licensed conjugate vaccines, such as 22F and 33F, are commonly associated with invasive pneumococcal disease worldwide. Both these serotypes currently cause 13% of the invasive pneumococcal disease seen among adults aged 65 years and older in the United States and 7-12% of the adult cases seen across Europe. Hence, a potential approval of the vaccine will bode well for Merck, given the targeted patient population.
Merck’s development program on V114 comprises 16 studies evaluating the safety, tolerability and immunogenicity of the vaccine in a variety of populations who are at increased risk for pneumococcal disease, including healthy older adults and children.
Merck’s shares have lost 7.2% this year so far against the industry’s 0.4% growth.
The company has a strong vaccine portfolio led by its human papillomavirus (“HPV”) vaccine, Gardasil. Gardasil/Gardasil 9 sales declined in the second quarter as COVID-19 hurt sales of the vaccine, particularly in the United States and Hong Kong. Merck expects its vaccines business to recover in the second half of 2020.
In June 2020, the FDA approved an expanded indication for GARDASIL9 for the prevention of oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58.
Apart from Gardasil, the company has several marketed vaccines in its portfolio like ProQuad/M-M-R II/Varivax, RotaTeq, Pneumovax 23 and Zostavax. However, Zostavax is facing stiff competition from Glaxo’s GSK Shingrix.
We remind investors that Pfizer PFE is also developing a 20-valent pneumococcal conjugate vaccine in late-stage studies.
Meanwhile, Merck is also striving hard to develop vaccines to help combat COVID-19. In June, it acquired Themis, which has a COVID-19 vaccine candidate, V591, in preclinical development with clinical studies expected to start shortly. Merck is co-developing private biotech Ridgeback Biotherapeutics’ oral antiviral candidate, MK-4482 (previously EIDD-2801), which is being evaluated in phase II studies for the treatment of COVID-19. Other companies in the race include Moderna, Inc. MRNA and Novavax, Inc.
Merck currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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