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Pfizer ($PFE) and Novartis ($NVS) have been racing to get their meningitis B vaccines to market for years. But as of Tuesday, the contest has never been closer, with both companies submitting approval applications to the FDA. Now, it's up to the agency to decide which shot gets the green light first--and first crack at the wide-open patient pool that comes with it.
Tuesday, both companies announced they had handed over their data to the FDA. Both vaccines already have the agency's breakthrough tag, which secures an expedited trip to market. If there's any advantage, it might be to Novartis, which scored safety and tolerability data from 10,000 people when the FDA shipped Bexsero in last year under investigational use to combat a pair of college campus outbreaks.
Analysts didn't originally see this scramble coming; many expected the Novartis jab, Bexsero, to enjoy the market all to itself for awhile before Pfizer's rLP2086 came around. But stellar Phase II data was enough to convince Pfizer to push forward with its filing--and now the two could be duking it out within days of the first FDA nod.
In addition to fighting each other for share, both companies could find themselves fighting slow uptake, thanks to the vaccines' targeted age range of 10-25 years. Despite the dangers of meningitis B, teenagers are generally vaccinated less often than infants, and the perceived risk of the disease in adolescents is low, ISI Group analyst Mark Schoenebaum wrote in a March note to investors.
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All in all, Schonebaum's conservative model yielded peak sales of about $225 million by 2019 for the Pfizer candidate; for comparison's sake, the company's Prevnar 13 brought in more than $4 billion last year. Back in April, Bernstein analyst Tim Anderson wrote in a note that Bexsero's commercial opportunity would "likely be modest."
A couple extra hurdles, however, won't faze Novartis, which will soon ship Bexsero--along with most of its vaccines business--off to GlaxoSmithKline ($GSK) as part of a multibillion-dollar asset swap. Pfizer, on the other hand, could use some extra revenue to pad its vaccines haul, which is generated entirely by the Prevnar franchise. After recently eyeing AstraZeneca's ($AZN) vaccines portfolio for growth--along with the rest of the company--that deal is now dead, at least for the time being.
- see Novartis' release
- and Pfizer's release
- read FierceBiotech's take
- get more from FierceVaccines here and here
Special Reports: Top 5 Vaccine Companies by Revenue - 2012 - Novartis - Pfizer