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Pfizer beats out Novartis with FDA MenB nod

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Dr. Emilio Emini, Pfizer's SVP of vaccine R&D

We have a winner. In a two-horse race with Novartis ($NVS) to grab the first-ever U.S. approval for a meningitis B vaccine, Pfizer ($PFE) has emerged victorious, nabbing the FDA's blessing Wednesday.

The green light for Pfizer's breakthrough-tagged vaccine, to be marketed as Trumenba, comes well ahead of the agency's PDUFA date, which regulators had set for Feb. 14. Recent meningitis B outbreaks on college campuses "heightened concerns for this potentially deadly disease," Karun Midthun, director of the FDA's Center for Biologics Evaluation and Research, said in a statement. 

Now, the U.S. could have MenB protection "within weeks," a Pfizer spokeswoman told FierceVaccines. "We are working as quickly as possible to make Trumenba available … to healthcare providers to administer the vaccine," she said via email. In a statement, Pfizer's SVP of vaccine R&D, Emilio Emini, called the approval "an important public health advance."

It's a come-from-behind victory for Trumenba, which analysts at one time expected to trail Novartis's Bexsero--already approved in Europe--to the U.S. market by quite a ways. But the Pfizer shot charted impressive Phase II study results--among participants who received three doses, 82% had antibodies that killed four different serogroup B strains, compared with less than 1% before vaccination--and that was enough to convince the company to push down the regulatory pathway. It filed for approval June 17, the same day as the Swiss drugmaker.

But that doesn't mean Trumenba won't have its own hurdles to face. Pfizer may have to contend with lowered uptake thanks to its targeted age range of 10 to 25, a group that's often vaccinated less than infants, ISI Group analyst Mark Schoenebaum wrote in a March note to investors. At the time, his conservative model yielded peak Trumenba sales of about $225 million by 2019.

In the meantime, Pfizer can tally another success in its quest to boost its vaccines business beyond the best-selling Prevnar franchise, a long-stated goal of CEO Ian Read's. Along with blockbuster Prevnar 13, Trumenba will join a pair of former Baxter ($BAX) jabs, which Pfizer agreed to pick up in a July deal, in the drug giant's marketed vaccine portfolio. 

- read the FDA's release
- read Pfizer's release

Special Reports: The top 5 vaccine makers by 2013 revenue - Pfizer | Top women in biotech 2014 - Susan Silbermann, Pfizer

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