Pfizer snags a 'breakthrough' tag for its meningitis vaccine in a race with Novartis

Pfizer ($PFE) picked up the FDA's breakthrough therapy designation for an in-development vaccine against meningococcal disease, a common cause of meningitis, lighting the path for an accelerated approval as the drugmaker looks to expand its vaccine portfolio beyond the blockbuster Prevnar 13.

The vaccine, dubbed rLP2086, targets 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, Pfizer said. The breakthrough tag entitles the vaccine to a fast-tracked FDA review and a front-row seat with regulators as makes its way through development, and Pfizer said it plans to file for approval by mid-year.

Of the 5 most common meningococcal serogroups, B is the only one with no FDA-approved, broadly effective vaccine, the company said, and that, coupled with rLP2086's mid-stage promise, informed the agency's decision. In two Phase II studies, Pfizer's jab spurred the development of meningococcal disease-fighting antibodies in teenage patients while charting a solid safety profile, according to Pfizer, leading the company to kick off a wider Phase III trial in late 2012.

That mid-2014 filing will come much earlier than expected, ISI analyst Mark Schoenebaum wrote in a note to investors, and it will put Pfizer in a head-to-head race with Novartis ($NVS), which this week revealed plans to submit the meningococcal B candidate Bexsero next quarter. Thanks to months of pre-approval use on college campuses, Novartis has a great deal of real-world safety and efficacy data to support its vaccine, but, unlike Pfizer, the Swiss drugmaker lacks the FDA's promise of a speedy review.

Meanwhile, Pfizer is working to to broaden the scope of its vaccine arm, using Prevnar 13 and its $4 billion-a-year sales to spark a growing R&D effort. In addition to its meningococcal entrant, the company is contending with GlaxoSmithKline ($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 the announcement