Biogen Idec (BIIB) recently announced the submission of a Biologics License Application (:BLA) for its recombinant factor VIII Fc fusion protein (rFVIIIFc). The company is seeking US Food and Drug Administration (:FDA) approval for rFVIIIFc for the treatment of hemophilia A.
The regulatory filing was based on results from the A-LONG study. FDA approval for rFVIIIFc would represent the first significant advancement in hemophilia A treatment in more than two decades.
We note that Biogen’s hemophilia B candidate, rFIXFc, is currently under FDA review. With the FDA granting standard review, a response from the agency regarding the approval status of rFIXFc should be out in the fourth quarter of this year.
A convenient dosing schedule (supported by a longer duration of action and a suitable safety profile) could help rFIXFc and rFVIIIFc capture share from existing products in the hemophilia market.
Meanwhile, Biogen has some other significant pipeline catalysts coming up, the most important being an update on the regulatory status of Tecfidera (BG-12). Tecfidera, Biogen’s oral multiple sclerosis candidate, is currently under review in both the US and the EU. A response in the US should be out this month. We believe Tecfidera could become a leader in the oral multiple sclerosis market once launched.
Biogen currently carries a Zacks Rank #3 (Hold). Key products, Avonex and Tysabri, should continue contributing significantly to sales. Tecfidera, if approved, should help drive long-term growth. However, we expect competition in the multiple sclerosis market to increase with the entry of Sanofi’s (SNY) Aubagio.
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