Biogen Idec has won 10 years of regulatory exclusivity for its top-selling multiple sclerosis (MS) drug Tecfidera in Europe, paving the way for its launch in markets that could account for a large chunk of future sales. The European Medicines Agency (EMA) said on Friday it had updated an earlier opinion and believed the oral medicine qualified as a so-called "new active substance" (NAS), securing Biogen vital protection that will stop generic firms from launching copycat versions.
Shares in Biogen jumped 10.5 percent to $279 on Nasdaq by 1500 GMT, after touching a new all-time high of $289.97. In March, Tecfidera was approved in the United States and also recommended for approval in Europe - but without clarity over whether it would get NAS status in the European Union. Its EU launch has been delayed pending a resolution of the issue.
Without this data protection, Biogen would have to rely on relatively weak patents relating to the drug's use, which analysts believe might not prevent generic rivals launching cheaper copies in major markets such as Germany. The revised recommendation will be referred to the European Commission, which usually endorses the views of the EMA's Committee for Medicinal Products for Human Use (CHMP) within a couple of months.
"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 patients in Europe," said Biogen research head Douglas Williams. "We are ready to introduce Tecfidera in EU countries shortly after anticipated approval."
J.P. Morgan analyst Geoff Meacham said the EU decision removed a major overhang for Biogen's prospects, although he noted most investors had been expecting a positive outcome. Meacham expects an EU launch of Tecfidera in the first half of 2014. Tecfidera competes with Novartis' Gilenya and Sanofi's Aubagio, two other oral MS therapies. Although it is a rival, Novartis said it welcomed the decision that dimethyl fumarate - the active ingredient in Tecfidera - qualifies as a new substance, since this would help support research and development into new medicines.
Oral treatments have proved a popular alternative to traditional drug injections for the debilitating neurological disorder and Tecfidera sales have exceeded market expectations, reaching $286 million in the third quarter. Annual sales are expected to reach $4.55 billion by 2018, according to consensus forecasts compiled by Thomson Reuters Pharma, with 36 percent of that coming from Europe and other non-US markets. Tecfidera was launched at a US price of $54,900 per patient a year. However, a Biogen executive said at a broker conference last week that Tecfidera might be priced at about half this level in Europe.
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