Biogen Idec delaying Tecfidera European launch
Biogen Idec Inc. (NASDAQ:BIIB) said it is delaying the launch of multiple sclerosis drug Tecfidera dimethyl fumarate ( BG-12) in Europe to next half. At the Deutsche Bank Health Care Conference on Thursday, CEO George Scangos said the company is "taking some time to clarify our regulatory data protection in the EU." Scangos, who said the biotech had planned to launch Tecfidera in Europe this half, declined to provide details.
EMA's CHMP recommended approval of an MAA for Tecfidera to treat adult patients with relapsing-remitting MS in March. The recommendation does not mention new active substance (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 declined to state when it expects a decision on the MAA; in March, Biogen Idec said it expected a decision within two months. In the EU, Tecfidera is protected by a patent covering a 480 mg dose that expires in 2028 and a method of use patent that expires in 2019. ...