Multiple sclerosis (MS) patients in Europe who want to try Biogen Idec’s new oral treatment Tecfidera will have to wait until the second half of 2013 as the company said its launch will be delayed.
Tecfidera (dimethyl fumarate) is expected to gain EU approval in the coming month – it was backed by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in March – but Biogen Idec says it wants to resolve patent and regulatory data protection issues before it makes the drug available.
Tecfidera was approved in the US in March 2013, becoming the third orally-active MS treatment to be registered after Novartis’ Gilenya (fingolimod) and Sanofi’s Aubagio (teriflunomide), and is expected to reach around $3bn in revenues at peak, ahead of its rivals.
In a filing with the Securities & Exchange Commission (SEC), Biogen Idec said it was awarded a European patent on May 29 that protects Tecfidera from generic competition until 2028.
However, the company says that it believes that Tecfidera “is also entitled to regulatory data protection in the EU”, adding that it is working to make Tecfidera’s status “clearer to all parties prior to launch”.
Analysts have suggested that the underlying aim may be to secure a new active substance (NAS) designation for the product in Europe, which would make Biogen Idec’s patents on the drug less vulnerable to legal challenges.
Earlier this year the CHMP declined an NAS designation for Aubagio despite recommending it for approval, in a move which could allow generic competition years earlier than expected.
“The goal is to launch with the strongest package in place”, says Biogen Idec in the SEC filing, adding that the delay “is prudent to preserve value over the long term”. The first commercial launch is now expected to take place in Germany in the second half of the year.