Merck and Co Inc (MRK)

[DewDiligence]

V114—MRK’s 15-valent pneumococcal vaccine—meets primary endpoint in two more phase-3 trials, setting the table for a BLA submission during 4Q20:

https://finance.yahoo.com/news/merck-announces-positive-topline-results-104500311.html

Merck…today announced findings from two additional Phase 3 studies evaluating the safety, tolerability and immunogenicity of V114, the company’s investigational 15-valent pneumococcal conjugate vaccine.

In the PNEU-PATH (V114-016) study, healthy adults 50 years of age or older received V114 or PCV13 followed by PNEUMOVAX 23 one year later. Immune responses following vaccination with PNEUMOVAX 23 (month 13) were comparable in both vaccination groups for the 15 serotypes in V114. Results also showed that at 30 days post vaccination with either V114 or PCV13 (day 30), immune responses were comparable for both groups across the 13 serotypes shared by the conjugate vaccines and higher in the V114 group for serotypes 22F and 33F, the two serotypes not included in PCV13.

In PNEU-DAY (V114-017), a Phase 3 study in immunocompetent adults 18 to 49 years of age with underlying medical conditions associated with increased risk for pneumococcal disease, V114 generated immune responses generally comparable to PCV13 for the 13 shared serotypes and higher immune responses for serotypes 22F and 33F at 30 days post-vaccination.

…V114 was generally well tolerated in both studies, with a safety profile consistent with that observed for V114 in previously reported studies.

Plans for global regulatory licensure applications, beginning with the U.S. Food and Drug Administration before the end of the year, remain on track.