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Biogen Idec up on Tecfidera EU exclusivity

November 23, 2013 2:28 AM UTC

Biogen Idec Inc. (NASDAQ:BIIB) jumped $33.19 (13%) to $285.62 on Friday after EMA's CHMP said multiple sclerosis drug Tecfidera dimethyl fumarate ( BG-12) qualifies as a new active substance (NAS). In March, the committee recommended approval of an MAA for Tecfidera to treat adults with relapsing-remitting MS, but the recommendation did not include NAS designation, which entitles a sponsor to eight years of data exclusivity plus two years of market exclusivity starting on the date of marketing approval. Biogen Idec appealed the decision and said it would delay the launch of Tecfidera in Europe to clarify "regulatory data protection in the EU." The company's stock subsequently slipped on Tecfidera's EU exclusivity concerns, hitting a low of $199.07 in June. ...