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Biogen wins FDA OK for long-acting hemophilia drug Alprolix

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Late on Friday the FDA announced that it had approved Biogen Idec's ($BIIB) long-acting hemophilia B drug Alprolix, setting the stage for a rough-and-tumble showdown among the new and old generations of drugs competing for the blockbuster market.

Alprolix is a Factor IX molecule tied to a protein fragment that gives its blood-clotting potency a longer-lasting punch.

"The approval of this product provides another therapeutic option for the treatment and prevention of bleeding in patients with Hemophilia B," said Dr. Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research.

Biogen, which has been making great headway developing new products under CEO George Scangos, says the new treatment can prevent bleeding episodes for up to two weeks. The big biotech is partnered on Alprolix with Swedish Orphan Biovitrum (Sobi) in Stockholm. And Novo Nordisk ($NVO) is coming up from behind with its longer lasting N9-GP, with an application expected next year.

Novo's NovoEight treatment, meanwhile, was approved last fall for hemophilia A while Biogen Idec is making progress with the late-stage Eloctate for hemophilia A, which is much more common than hemophilia B.

Baxter ($BAX), which specializes in the market, and Pfizer ($PFE) may end up quickly marginalized as these next-gen treatments gain traction in the marketplace.

The big question now appears to be how Biogen will price the therapy. If it's priced in line with current short-acting therapies, analysts expect it may be quickly adopted and force a quick discount on the older products. If it can earn recognition as a big step up, though, Biogen may also be able to capitalize on a premium price.

Reuters recently reported that Baxter's Advate and Pfizer's Xyntha dominated a market that earned $8.5 billion in 2011, with the market expected to grow to more than $11 billion by 2016, according to Morningstar.

- here's the release from the FDA

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