In the race between two pharma giants
in a multibillion-dollar field, Merck Monday posted two trial wins. With
the data, the drugmaker is preparing to file its next-gen pneumococcal
vaccine candidate, V114, with regulators worldwide.
Merck’s 15-valent vaccine candidate met
its objectives in two phase 3 studies in certain patient populations,
the New Jersey drugmaker said.
One study tested the vaccine candidate in patients 18 and older who are
living with HIV, and the other focused on patients 50 and older who
also received a quadrivalent flu vaccine.
In the first study, V114 elicited an
immune response against all 15 serotypes included in the shot.
The second study showed that the vaccine can be given at the same time
as a quadrivalent flu vaccine, Merck said.
The tests are only two out of
16 late-stage studies for the vaccine in various patient populations. As
the program moves forward, Merck is discussing regulatory filings with
authorities in the U.S. and elsewhere.
On the company’s first-quarter
conference call earlier this year, R&D head Roger Perlmutter said
Merck is “really very enthusiastic about this vaccine because of the
important new serotypes in it and also the balance with respect to the
immune response that we saw in our V114 studies” in earlier testing.
Meanwhile, Pfizer is also pushing forward with its 20-valent shot, a follow-up to the mega-successful Prevnar 13. The company unveiled positive phase 3 data in March and said it was on track for an FDA filing this year.
Pfizer’s Prevnar 13 pulled in $5.8 billion last year, underscoring the size of the potential market at stake.
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