Biogen Idec (BIIB - Analyst Report) and partner, Swedish Orphan Biovitrum recently presented encouraging data on their hemophilia candidates, rFVIIIFc and rFIXFc. Results, which were presented at the annual meeting of the European Association for Haemophilia and Allied Disorders (EAHAD), showed that the candidates provided long-lasting protection from bleeding with fewer injections compared to the current standard of care for hemophilia patients.
The pharmacokinetic activity of rFVIIIFc (hemophilia A) and rFIXFc (hemophilia B) was compared to that of currently available treatments. Results showed that rFVIIIFc and rFIXFc stayed active in the body for a longer period of time thereby allowing the prevention of bleeding with fewer injections than currently required.
Biogen recently submitted a Biologics License Application (BLA) seeking US Food and Drug Administration (FDA) approval for rFIXFc for hemophilia B. Currently available treatments for hemophilia B include Pfizer’s (PFE - Analyst Report) BeneFIX.
Meanwhile, the US regulatory filing for rFVIIIFc for hemophilia A should also take place in the first half of 2013. 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 by March. We believe Tecfidera could become a leader in the oral multiple sclerosis market once launched.
Biogen currently carries a Zacks Rank #3 (Hold). Biotech companies that currently look interesting include Alkermes (ALKS - Analyst Report), which carries a Zacks #1 Rank (Strong Buy), and Elan , which carries a Zacks Rank #2 (Buy).