Novartis' Bexsero wins FDA 'breakthrough' status

A couple of weeks ago, the FDA handed Pfizer's ($PFE) meningitis B candidate its breakthrough therapy designation, setting it up for a race to market with Novartis' ($NVS) Bexsero. Now, the Swiss company's jab has one to match, meaning it may not be long before it can start contributing some much-needed sales to Novartis' vaccines unit.

Monday, the FDA granted Bexsero its own breakthrough label, which entitles candidates for serious or life-threatening conditions to an expedited development and review process. While the FDA and Novartis had already revealed the anticipated timing for Novartis' Q2 regulatory filing, the new status brings with it a fast-tracked review process that should get the shot to market sooner.

Bexsero, already approved in the EU, Australia and Canada, had been held up in the U.S., with the FDA and Novartis previously tangled in negotiations over its Phase III trial design. But recent meningitis B outbreaks at Princeton University and the University of California, Santa Barbara, sped things along, with the U.S. importing nearly 30,000 doses to combat the disease. Novartis now has safety and tolerability data from the 14,000 people vaccinated on campuses--6,000 more than the number of participants in the trial that helped Bexsero win approval elsewhere.

"The recent outbreaks on U.S. university campuses have shown that meningitis B is unpredictable and can strike at any time with devastating consequences," Andrin Oswald, the head of Novartis Vaccines, said in a statement. "A U.S. license for Bexsero is the only sustainable solution to ensure timely responses to future outbreaks and to provide access to parents and physicians across the country. We will continue to work with the FDA to bring Bexsero to the U.S. as soon as possible."

It's welcome news for Novartis, as analysts have long pinned the vaccines unit's future on Bexsero's success. Created in 2006 with the company's $7.5 billion buyout of Chiron, the division was the only one of the company's businesses to post an operating loss in 2013, and CEO Joe Jimenez has said it could soon be on its way out.

But while Bexsero may provide some sales relief in the U.S., it won't be the only MenB vax on the block for long--if at all. Pfizer's breakthrough nod for rLP2086 should allow it to file for approval based on Phase II data by midyear, the company said late last month.

- read the release