Both Pfizer ($PFE) and Novartis ($NVS) have picked up the FDA's much-coveted breakthrough-therapy designation for their meningitis B vaccines, and now the rivals have chosen the same day to submit their injections for approval, leaving it up to regulators which will hit the market first.
Pfizer's vaccine, a recombinant version of the LP2086 protein, targets cases of meningococcal disease caused by Neisseria meningitidis B, an infection that afflicts up to 80,000 people each year and can lead to death or disability. Novartis' candidate, already marketed in 34 countries as Bexsero, is the first ever approved for meningitis B, one of 5 serotypes that account for the vast majority of meningococcal disease cases. Neither is commercially available in the U.S.
Each treatment received the FDA's breakthrough tag--Pfizer's in March and Novartis' in April--and, with applications in hand, the agency now has 60 days to review the filings. If and when it accepts them, the FDA will set a final decision date for each vaccine.
Pfizer's submission is part of a come-from-behind story for rLP2086, as analysts widely expected Bexsero to make its way to market well ahead of the rival shot. But excellent Phase II data demonstrated that Pfizer's vaccine spurred the development of meningococcal disease-fighting antibodies in patients while charting a solid safety profile, results the company deemed good enough for regulatory approval.
However, Novartis' vaccine may have a commercial advantage once the two reach the market. Last year, with the FDA's blessing, the company administered about 30,000 doses of the unapproved Bexsero to students at Princeton University and the University of California, Santa Barbara, in response to meningitis B outbreaks, giving the company some real-world safety and efficacy data, plus public name recognition.
Any advantage will largely be a benefit for GlaxoSmithKline ($GSK), of course, as the company has signed up to trade $7.1 billion for Novartis' non-flu vaccine business, a deal expected to close by mid-2015. Bexsero's potential is vital to what has been a slow-footed vaccines unit, struggling since coming over wholesale in a $7.5 billion deal for Chiron in 2006.
For its part, Pfizer is working to broaden the scope of its vaccine arm, using Prevnar 13 and its $4-billion-a-year sales to spark a growing R&D effort. In addition to its meningococcal entrant, the company is contending with GSK, Novartis and Sanofi ($SNY) to develop a Staphylococcus aureus vaccine that, if approved, could take pole position in what's expected to be a $4 billion market.
- read Novartis' release
- here's Pfizer's statement
Editor's note: An earlier version of this story mischaracterized GlaxoSmithKline's deal with Novartis. We regret the error.