Biogen’s multiple sclerosis drug EU approval delayed

Biogen Idec expects the European launch of its multiple sclerosis drug to be delayed until the second half of 2013, after seeking an extension on the drug’s patent protection.

This extension was granted yesterday and means that Tecfidera (dimethyl fumarate) will be protected from generic competition until 2028. The drug’s previous patent was not a “compound” patent and could therefore have been challenged, according to analysts.

Tecfidera received FDA approval for use in the United States earlier this year, and is widely seen as Biogen’s most important growth driver. Estimated 2013 sales stand at US $300 million, with eventual peak sales of $3 billion.



Related news:

Biogen delays MS drug’s EU launch to secure market exclusivity (Reuters)

Biogen MS Pill Delayed in Europe as Patent Extended to 2028 (Bloomberg Business week)

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