Biogen Idec gains on Tecfidera news

Biogen Idec Inc. (NASDAQ:BIIB) was up $3.04 to $252.26 on Friday after EMA's CHMP said it will "likely" make a decision in November on the new active substance (NAS) designation for multiple sclerosis drug Tecfidera dimethyl fumarate ( BG-12). 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." ...