Pfizer puts the heat on Novartis with FDA MenB filing

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

There's nothing like a neck-and-neck race, and that's just what Pfizer's ($PFE) breakthrough-designated meningitis B candidate created when stellar Phase II data helped it surge ahead on its regulatory pathway to catch up with Novartis' ($NVS) Bexsero. And now, with the two companies submitting applications for approval on the same day, whether Pfizer's jab reaches the market first will be up to the FDA to decide.

On Tuesday, the company announced it had handed over a Biologics License Application (BLA) for its meningitis B jab, dubbed rLP2086, to U.S. regulators. The agency now has a review period of 60 days to make sure all looks well and good with the filing, and if it does, it will then announce a final decision date for approval.

"The BLA submission for bivalent rLP2086 marks an important step toward our goal of helping to protect adolescents and young adults against this difficult to diagnose and often deadly disease," Dr. Emilio Emini, Pfizer's SVP of vaccine R&D, said in a statement. "There is an urgent public health need to help prevent meningococcal B disease through vaccination, and we will continue to work closely with the FDA in our efforts to advance our vaccine candidate."

That candidate once looked like it would trail quite a ways behind Novartis' rival jab, with analysts expecting Bexsero to enjoy a healthy first-to-market advantage. But impressive Phase II results demonstrated that rLP2086 could safely spur the development of meningococcal disease-fighting antibodies in patients, which was enough to convince Pfizer to charge on down the approval pathway.

Now, the two vaccines are racing for the market, with the Swiss pharma also submitting an application for FDA approval Tuesday. And in addition to competition, Pfizer may also have to contend with lowered uptake thanks to its targeted age range of 10 to 25; despite the potentially fatal outcome of meningitis B, teenagers are often vaccinated less 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.

All things considered, Schoenebaum's conservative model yielded peak sales of about $225 million by 2019--a far cry from the blockbuster numbers its giant Prevnar 13 puts up each year. But Pfizer, looking to build out its vaccines lineup beyond Prevnar, will take any added revenue it can get. While it recently eyed AstraZeneca's ($AZN) vaccines business for growth, its proposed deal for the British drugmaker is on the rocks--for now.

- read the release

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