) 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
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
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
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
), which carries a Zacks #1 Rank (Strong Buy), and
), which carries a Zacks Rank #2 (Buy).
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