Merck's next-gen pneumococcal vaccine scores in phase 3 amid race with Pfizer

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.

Looking forward toward the market race, SVB Leerink analyst Geoffrey Porges predicted in a note to clients that Pfizer's vaccine will "ultimately win majority share" in adults, while the "infant indication faces more uncertainty." Merck has already started a phase 3 trial in infants that's set to wrap up next May, he wrote. Pfizer's trial enrollment could hit snags due to the pandemic, he added, possibly giving Merck a head start in that indication.

Jun 22, 2020

https://www.fiercepharma.com/

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