Monday, May 12


WASHINGTON (AP) -- Shares of Biogen Idec jumped to an all-time high Friday morning after the company said European regulators have determined its new multiple sclerosis medication is a novel drug, granting it 10 years of market exclusivity in the European Union.
Biogen said in a statement that the European Medicines Agency granted its drug Tecfidera status as a "new active substance." The designation means that generic drugmakers will not be able to launch cheaper versions of the multiple sclerosis for 10 years. 
The background: Analysts expect that Tecfidera, a pill taken once a day, will become a leading treatment for multiple sclerosis. The U.S. Food and Drug Administration approved it in late March. Biogen already markets three other drugs for multiple sclerosis in Europe, including the blockbuster Tysabri. In April Biogen paid $3.25 billion in cash to acquire full rights to Tysabri from partner Elan.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) determined that Tecfidera (dimethyl fumarate) qualifies as a new active substance (NAS) and therefore gains patent protection.
"We are heartened by the CHMP's NAS determination, which brings us closer to our goal of providing this important new treatment to multiple sclerosis (MS) patients in Europe. We are ready to introduce TECFIDERA in EU countries shortly after anticipated approval. This designation validates the tremendous investment we have made in TECFIDERA and enables us to invest in future research focused on reversing the course of MS and hopefully one day finding a cure for patients."

Douglas Williams, Ph.D., executive vice president of Research and Development at Biogen Idec.