Biogen Idec (NAS: BIIB) looks like it'll be able to turn into a full-fledged hemophilia drug company. Last month, the company said its Factor IX Fc fusion protein that it's developing with Swedish Orphan Biovitrum, passed its clinical trial, stopping bleeding in patients with hemophilia B with less shots than Pfizer's (NYS: PFE) BeneFIX.
On Wednesday, Orphan Biovitrum and Biogen were back with more good news for a drug for the much-larger hemophilia A market. The drug uses the same Fc fusion protein technology to make the therapeutic drug last longer, but it's linked to Factor VIII, which is the protein missing from patients with hemophilia A.
In the trial, rFVIIIFc was able to control bleeding with one or two injections 98% of the time. Patients on an individualized schedule for dosing, with the average patient taking the drug once every 3.5 days, only saw an annualized bleeding rate of 1.6. Patients who took the drug weekly had a bleeding rate of 3.6, and patients who took the drug only after a bleeding episode, which acted as a control group, had a bleeding rate of 33.6.
Patients are able to take the drug less often because the drug lasts longer in the bloodstream. A comparison of rFVIIIFc to Baxter's (NYS: BAX) Advate showed that half the rFVIIIFc was gone after 19 hours, compared to just 12.4 hours for Advate.
Biogen plans to submit a marketing application for rFVIIIFc in the first half of next year. In Europe, the companies will have to do a clinical trial in children before it can be approved there.
The long-lasting formulation should help Biogen compete against the current offerings, but the drugs may have competition from other long-lasting hemophilia drugs in the near future. Baxter and Novo Nordisk (NYS: NVO) are both developing long-acting Factor IX drugs for hemophilia B, and Novo Nordisk has one for hemophilia A, as well .
Even if it won't be a cakewalk, the shift to diversify away from multiple sclerosis is likely to be a good long-term move for Biogen.
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