The FDA action date for
) hemophilia B candidate, Alprolix, has been pushed back by three
months, which means the company will most likely be able to
launch Alprolix later in the first half of 2014 provided it gains
FDA approval for its Biologics License Application (BLA).
The FDA had asked Biogen to submit additional information
related to the validation of a manufacturing step for Alprolix.
The FDA will need extra time to review the BLA given the timing
of the submission of the additional information.
This is the second delay being faced by Biogen where its
hemophilia pipeline is concerned. Last month, Biogen had
disclosed that the FDA has asked the company for additional
information on certain steps in the validation process in the
manufacturing plan for its hemophilia A candidate, Eloctate. We
believe this will push out Eloctate's launch to mid-2014 instead
of sometime in the second quarter of 2014.
We do not expect the news of the delay in the approval dates
for the hemophilia candidates to have a significant impact on the
shares. In fact, Biogen has been enjoying a strong run ever since
the Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) granted new active substance
(NAS) designation to dimethyl fumarate in the company's new oral
multiple sclerosis treatment, Tecfidera.
Tecfidera is one of the most important new products in
Biogen's portfolio. Although Tecfidera is protected by a European
patent until 2028, the 10 years of regulatory exclusivity
strengthens patent protection for the candidate further.
Biogen currently carries a Zacks Rank # 3 (Hold). Some
better-ranked stocks include
). While Actelion is a Zacks Rank #1 (Strong Buy) stock, Acorda
and Aeterna are Zacks Rank #2 (Buy) stocks.
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