It's not exactly like Biogen Idec (Nasdaq: BIIB) has any bleeding to stop -- shares are up 60% over the past year -- but the company did anyway.
With partner Swedish Orphan Biovitrum, Biogen said today that its recombinant Factor IX Fc fusion protein, or rFIXFc, controlled and prevented bleeding in patients with hemophilia B. When used as a treatment, 90.4% of bleeding episodes were controlled by a single intravenous injection of rFIXFc. And when the drug was used as a prophylactic, annualized bleeding rates were between 1.38 and 2.95 episodes per year compared to 17.69 for the group that only used the drug as a treatment.
The drug replaces a deficiency of Factor IX protein that occurs in patients with hemophilia B. Pfizer's (NYSE: PFE) BeneFIX is the same protein, but Biogen and Swedish Orphan Biovitrum's lasts longer. It takes 82 hours for half of the injected rFIXFc protein to be degraded compared to 34 hours with BeneFIX. If the drug is lasting longer, patients have to get fewer injections. Current options require intravenous injections up to three times a week, but patients using rFIXFc extended the treatment out to once every other week.
Biogen looks set to take much of the $1 billion hemophilia B market, although it might have competition from Novo Nordisk (NYSE: NVO), which has a long-acting Factor IX drug of its own in phase 3 trials. Baxter (NYSE: BAX) also has a Factor IX protein, BAX 326, under review at the Food and Drug Administration. Investors will be able to do a side-by-side comparison when Baxter presents the data later this year.
The most exciting thing about the rFIXFc results is that it proves that the Fc-fusion technology used to block the degradation is working. Biogen and Swedish Orphan Biovitrum are using that same technology to develop a long-lasting version of Factor VIII, which patients in the larger hemophilia A market require.
With solid data in hand, Biogen plans to apply for approval in the U.S. in the first half of next year. EU approval will have to wait until a trial on kids is complete. Between the hemophilia programs and its multiple sclerosis drug BG-12, Biogen looks set to coagulate more revenue in the not-too-distant future.
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