Three months after winning the FDA’s breakthrough therapy designation for its bigger/better pneumococcal conjugate vaccine candidate aimed at toppling Pfizer’s Prevnar 13 megablockbuster bestseller, Merck is back with a batch of upbeat Phase II data from their big clinical program.
In a nutshell, Merck researchers say that V114 proved non-inferior to Prevnar 13 on the lineup of pneumococcus strains it guards against — while also illustrating its effectiveness to boot up an immune response against two additional disease-causing serotypes, 22F and 33F, not covered by the Pfizer vaccine.
Merck is best known for Keytruda right now, its chart-topping leader in the PD-1 field. But the company is beginning to get stuck with a rep for putting too many eggs in one basket, neglecting the rest of the pipeline while it builds billions of sales in oncology.
Keytruda remains the key clinical focus, but Merck R&D chief Roger Perlmutter is also putting on an impressive late-stage campaign for V114 that might take some of the sting out of the criticism. Merck has a juggernaut of 11 Phase III programs for V114 underway, covering children and adults. And they want to do to Pfizer what it took a few years to do with Bristol-Myers Squibb, leapfrogging the lead player.
But it’s not the only rival for the Prevnar 13. Little SutroVax is also suited up for this game of blockbusters, with a candidate that covers 20-plus serotypes, several better than Merck’s treatment.
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