The US Food and Drug Administration (FDA) recently accepted
) Biologics License Application (BLA) for its hemophilia A
candidate, Eloctate (recombinant factor VIII Fc fusion
Biogen had submitted the BLA in Mar 2013. The regulatory
filing was based on results from the A-LONG study. FDA approval
for Eloctate would represent a significant advancement in
hemophilia A treatment in more than two decades. The FDA has
granted standard review which means a response regarding the
approval status of Eloctate should be out early next year.
We note that Biogen's hemophilia B candidate, Alprolix, is
also under FDA review. With the FDA granting standard review, a
response from the agency regarding the approval status of
Alprolix 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 Eloctate and
Alprolix capture share from existing products in the hemophilia
market. According to Biogen, Eloctate has the potential to reduce
the number of intravenous injections by 50 to 100 per year in
patients currently on preventive treatment.
We are pleased with the pipeline progress at Biogen. The
company received a major boost in late March with the FDA
approval of its oral multiple sclerosis drug, Tecfidera. We
expect Tecfidera to gain EU approval shortly - the Committee for
Medicinal Products for Human Use (CHMP) had issued a positive
opinion regarding the approval of Tecfidera in Mar 2013.
Biogen currently carries a Zacks Rank #3 (Hold). At present,
Anika Therapeutics Inc.
Alexion Pharmaceuticals, Inc.
) look well-positioned. While Anika is a Zacks Rank #1 (Strong
Buy) stock, Alkermes and Alexion are Zacks Rank #2 (Buy) stocks.
ALKERMES INC (ALKS): Free Stock Analysis
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