) 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
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
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
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
Companies that currently look interesting include
). Both are Zacks Rank #1 (Strong Buy) stocks.
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