Biogen Idec Inc. just announced that its new multiple sclerosis (MS) drug, Tecfidera, received approval to be marketed in Europe. European health regulators made the decision after the European Medicines Agency endorsed the drug in November. The United States, Canada, and Australia have already approved Tecfidera.
The market impact of Tecfidera is expected to be substantial. Considering that an estimated 400,000 people in Europe have multiple sclerosis, the fact that Tecfidera will be only the third oral MS drug for sale in Europe is expected to make a quick, sustained impact on sales. Given the proven efficacy of the drug, analysts also believe that Tecfidera may actually surpass current multiple sclerosis drugs Gilenya from Novartis and Aubagio from Sanofi, in market sales.
The expected success of Tecfidera follows from the fact that it shattered Wall Street sales forecasts and has an outlook to reach more than $1 billion in sales within its first year on the American market. Sales had already reached $398 million by the end of Tecfidera’s third full quarter on the market.
In the coming weeks, sales will begin in Germany. “We’re ready to go,” said Tony Kingsley, Biogen’s head of global commercial operations, which was not always the case. Biogen was hesitant to introduce Tecfidera in Europe due to uncertainty about protection against generic copies, but Biogen won ten years of regulatory exclusivity in November 2013. Now, “we’re very encouraged by our U.S. experience,” said Kingsley.