Ready to spar with Pfizer's meningitis B jab, Novartis gets FDA green light for Bexsero

Novartis ($NVS) has long pinned its hopes on meningitis B shot Bexsero to revitalize its lagging vaccines unit. Now, the company is celebrating the product's FDA approval, even as it prepares to hand off the jab to GlaxoSmithKline ($GSK) in a blockbuster asset swap.

The Swiss drugmaker scored accelerated approval for Bexsero for 10- to 25-year-olds, putting it second to market after Pfizer's ($PFE) Trumenba, approved in October. Novartis touts Bexsero's two-dose regimen--Trumenba requires three--and a flexible dosing schedule as advantages over Trumenba.

Bexsero also had 15 minutes of public fame in 2013, when the FDA allowed two universities to use the jab to quell outbreaks of meningitis B. Some 15,000 students at Princeton University and the University of California, Santa Barbara were vaccinated against the disease, which can be deadly within 24 hours.

The FDA based its approval on three studies that looked at the jab's efficacy in 2,600 adolescents and young adults. Up to 82% of individuals who received two doses of Bexsero had antibodies against three strains of meningitis B, compared with as much as 23% of study participants before vaccination.

The agency nod comes as Novartis prepares to hand off its struggling vaccines business to GSK as part of a three-way deal. The company's vaccines division, formed in 2006 with its $7.5 billion buyout of Chiron, posted a $165 million operating loss in 2013.

GSK, with its global vaccines prowess, sees that newly beefed-up business as one of four key franchises that can drive 70% of sales moving forward. With the global market for meningitis vaccines set to triple to $3.6 billion by 2020, Bexsero presents a potentially lucrative boost to GSK's portfolio. "The addition of Bexsero, a new vaccine for the prevention of meningitis B ... will strengthen GSK's position in one of the fastest-growing segments of the vaccines market," the company told shareholders last year.

Bexsero is not the only meningitis B jab on the block, though. The vaccine faces competition from Trumenba, which charted impressive Phase II study results. Some 82% of participants who received three doses developed antibodies to four different serogroup B strains, compared with less than 1% before vaccination.

U.K. Health Secretary Jeremy Hunt

Meanwhile, Novartis continues to battle it out with the British government over Bexsero pricing. In November, U.K. Health Secretary Jeremy Hunt accused the Basel-based drugmaker of "holding the government to ransom" with its £300 ($504) list price for a four-dose course--a number well above the £3 to £22 range found cost-effective by a recent study from BMJ. Novartis vaccines chief Andrin Oswald shot back, saying it had "gone to great lengths to support a swift implementation of a vaccination campaign." The company also reportedly offered 1 million doses free of charge, to prime the pump for that campaign.

- read the FDA statement
- here's Novartis' release (PDF)

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