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Biogen Idec wins EU battle on Tecfidera exclusivity

Oral MS drug gains New Active Substance status

Biogen Idec building 

Biogen Idec has been buoyed by victory in its longstanding battle to secure market exclusivity for its oral multiple sclerosis (MS) drug Tecfidera in the EU.

Shares in the US biopharma company climbed around 10 per cent on Friday after the Committee for Medicinal Products for Human Use (CHMP) agreed that the active ingredient in Tecfidera - dimethyl fumarate - should be classed as a New Active Substance (NAS) in the EU.

Biogen Idec has delayed the introduction of Tecfidera in Europe while the matter was resolved, and can now move ahead with a launch, secure in the knowledge that it has gained 10 years of regulatory exclusivity for the fast-growing product.

Tecfidera was approved in the US in March, becoming the third orally-active MS treatment to reach the market after Novartis' Gilenya (fingolimod) and Sanofi's Aubagio (teriflunomide), and has romped away in its first few months on the market, racking up around $500m in sales in its first six months.

The drug was awarded a European patent on May 29 that protects it from generic competition until 2028, but has also been pushing for regulatory data protection and NAS status, which will confer an additional level of protection against patent challenges.

Biogen Idec said in a statement that Tecfidera's EU approval has been delayed while the regulatory status of the drug is resolved, but now - with a CHMP positive opinion already in the bag - it can now be referred to the European Commission for a final ruling on the marketing application.

"We are ready to introduce Tecfidera in EU countries shortly after anticipated approval," said the company's executive vice president of R&D Douglas Williams.

Analysts have predicted that the drug could lead the market for oral MS therapies as they become established in favour of injectable interferon-based treatments, with sales of $3bn-a-year or more in 2016.

Article by
Phil Taylor

25th November 2013

From: Sales, Regulatory



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