Pfizer prepares to file for approval with positive PhII MenB data

Last March, Pfizer ($PFE) announced it would file for approval for its meningitis B candidate, which grabbed the FDA's breakthrough label earlier this year, based on Phase II data. Now, it has what it wants: positive results from a pair of midstage trials for the jab that will keep it on track for expedited approval--and a showdown with Novartis' ($NVS) Bexsero that could be waiting at the end of the regulatory pathway.

In each of the two studies, the experimental shot, dubbed rLP2086, generated bactericidal responses, an indicator of functional immune response, against MenB test strains following two or three doses, the company said. And in one study, rLP2086 showed no impact on the immune response to the dTaP-IPV vaccine when the two were administered together.

Dr. Emilio Emini--Courtesy of Pfizer

"We are encouraged by the safety and tolerability data for our investigational vaccine candidate, bivalent rLP2086, and its potential to help prevent this devastating disease," Dr. Emilio Emini, Pfizer's SVP of vaccine R&D, said in a statement. "We look forward to continuing the development of this critically needed vaccine and working with regulatory authorities to make it available to adolescents and young adults."

But Pfizer's is not the only MenB jab speeding through the clinic. Less than two weeks after bestowing breakthrough status on the New York company's up-and-comer, the FDA granted Novartis' Bexsero--soon to join the pipeline of GlaxoSmithKline ($GSK), which struck a deal to buy much of Novartis' vaccines unit last month--the same designation.

As ISI Group analyst Mark Schoenebaum wrote in a March note to investors, he expects the two vaccines to compete. That market-share battle, along with rLP2086's targeted age group of adolescents between 10 and 25 years old--a group not as frequently vaccinated as infants--yield a conservative peak sales estimate of about $225 million by 2019, he said.

Pfizer CEO Ian Read

While that pales in comparison with the top-line power blockbuster Prevnar 13 puts up, it will be a welcome addition to the company's lineup. Right now, Prevnar is essentially Pfizer's only marketed vaccine, and though it's the top-selling shot in the world, it's not enough to keep Pfizer competitive with big guns Glaxo, Merck ($MRK) and Sanofi ($SNY).

But CEO Ian Read has some other ideas on how to expand its vaccines business that don't involve Pfizer's pipeline. He's already made two $100 billion-plus bids for British drugmaker AstraZeneca ($AZN), which boasts products like FluMist and, in Europe, Fluenz Tetra, along with a trio of Phase I prospects.

- read the release

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