) announced that its hemophilia B drug, Alprolix, gained approval
in Canada. Health Canada approved the drug for controlling and
preventing bleeding as well as for routine prophylaxis in adults
and children (≥12 years) suffering from hemophilia B.
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We note that Alprolix is the first long-acting therapy for
hemophilia B to gain approval. Biogen is currently seeking
approval for Alprolix from the U.S. Food and Drug Administration
(FDA) for hemophilia B. Feedback should be out in the second
quarter of 2014.
Biogen is also seeking FDA approval for another hemophilia
candidate − Eloctate for hemophilia A. A feedback from the FDA
should be out by mid-2014. The company is conducting pediatric
studies on Alprolix and Eloctate. Data from these studies are
required for regulatory applications in the EU.
We note that Biogen has another candidate, Plegridy, under review
in the U.S. and the EU. The company is looking to get the
candidate approved for the treatment of relapsing-remitting
multiple sclerosis. A response should be out in the second half
We expect 2014 to be a catalyst rich year for Biogen. Apart from
receiving a response from regulatory authorities regarding
Eloctate, Alprolix and Plegridy, Biogen expects several
proof-of-concept or proof of biology read-outs this year,
including data on anti-LINGO (acute optic neuritis), BIIB037
(Alzheimer's disease), neublastin (neuropathic pain), STX-100
(idiopathic pulmonary fibrosis) and anti-CD40 (lupus).
Biogen is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks
in the health care sector include
ANI Pharmaceuticals, Inc.
Alexion Pharmaceuticals, Inc.
). All these stocks carry a Zacks Rank #1 (Strong Buy).