The FDA action date for Biogen Idec’s (BIIB) 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 Actelion Ltd. (ALIOF), Acorda Therapeutics (ACOR) and Aeterna Zentaris (AEZS). While Actelion is a Zacks Rank #1 (Strong Buy) stock, Acorda and Aeterna are Zacks Rank #2 (Buy) stocks.
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