Biogen's Plegridy Closer to EU Approval - Analyst Blog

Biotech company, Biogen Idec BIIB, well known for its strong presence in the multiple sclerosis MS market, received a boost with the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issuing a positive opinion for its multiple sclerosis candidate, Plegridy (peginterferon beta-1a).

Biogen is looking to get Plegridy, a pegylated interferon administered subcutaneously, approved for use in adults with relapsing-remitting multiple sclerosis RRMS. A decision from the European Commission EC regarding the candidate's approval status should be out in the second half of the year. With the CHMP issuing a positive opinion, we believe chances of gaining approval in the EU are high.

Plegridy is also under review in the U.S. where a response should be out in the second half of the year.

Biogen's MS portfolio consists of drugs like Avonex, Tysabri and Tecfidera. Tecfidera is off to a strong start in the U.S. and already holds a leading position in the oral MS market. We expect the drug to do well in the EU too where it was launched recently.

Biogen is working on consolidating its position in the MS market. In addition to Plegridy, Biogen has daclizumab in its MS pipeline. Biogen and partner AbbVie ABBV are conducting a two-year phase III study (DECIDE) on daclizumab with results due this year. Biogen is also looking to expand Tysabri's label and is conducting a phase IIIb study (ASCEND) in combination with daclizumab in patients with secondary-progressive MS - results are expected in 2015.

Biogen is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the biotech sector include Gilead Sciences Inc. GILD and Osiris Therapeutics OSIR. Both are Zacks Rank #1 (Strong Buy) stocks.

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