'Breakthrough' nod for Pfizer MenB candidate sets up showdown with Bexsero

Pfizer's ($PFE) approval pathway for its meningococcal B vaccine just got shorter. On Thursday, the FDA designated the candidate, dubbed rLP2086, as a breakthrough therapy, which will speed its trip through the regulatory process--and put it in a head-to-head battle with Novartis' ($NVS) Bexsero.

With breakthrough status, Pfizer's vaccine gets a fast-tracked FDA review that should allow it to file for approval based on Phase II data by midyear, the company said. As of now, of the 5 meningococcal serogroups, the deadly B is the only one without an FDA-approved vaccine.

"We are encouraged by the FDA's recognition of the need to prevent meningococcal B disease, and the Breakthrough Therapy designation highlights the urgent need for prevention of meningococcal B disease," Dr. Emilio Emini, Pfizer's SVP of vaccine research and development, said in a statement.

That urgent need--recently highlighted with meningitis B outbreaks on U.S. university campuses, including those of Princeton University and the University of California, Santa Barbara--may also have catalyzed an accelerated regulatory pathway for Bexsero, ISI Group analyst Mark Schoenebaum wrote in a note to investors. Novartis, which got the FDA's OK to ship in the European-approved jab to combat the outbreaks, now plans to file for U.S. approval in Q2--ahead of schedule, reports say.

But while the two shots will compete, there are some important differences to note between them, Schoenebaum says. For one, the FDA is evaluating Pfizer's candidate primarily in adolescents and adults ages 10 to 25, as opposed to Bexsero's clinical data, which are largely for infants and young children. And for Pfizer, that means a potentially lower uptake, with a conservative model yielding peak sales of about $225 million by 2019, Schoenebaum wrote.

"Despite the potentially fatal outcome of meningococcal B, we expect uptake for the vaccine to be lower than that seen for other vaccines like PFE's Prevnar 13, where >90% of all infants get the vaccine in the U.S.," Schonebaum wrote. "… In contrast to infants, teenagers are often vaccinated less, and the perceived risk of meningococcal disease in adolescents is low."

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