Biogen prevails in EU exclusivity battle for MS drug Tecfidera

US biotech company Biogen Idec (Nasdaq: BIIB) saw its shares leap 10% to an all-time high of nearly $278 on Friday (November 22), as the company received positive news regarding its long fight to gain market exclusivity in Europe for its new multiple sclerosis drug Tecfidera (BG-12; dimethyl fumarate).

The news was that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has determined that dimethyl fumarate qualifies as a new active substance (NAS). This designation will provide 10 years of regulatory exclusivity for Tecfidera in the European Union, and gives Biogen the green-light for a European launch, which the company has delayed pending a resolution to the exclusivity issue.

The drug gained a recommendation from the CHMP for marketing earlier this year (March 25). The CHMP’s determination will now be referred to the European Commission, which grants marketing authorization for medicines in the EU. Launched in the USA in April, Tecfidera's third-quarter 2013 sales reached $286 million, significantly beating the $205 million or so projected by analysts.