Biogen Idec sees EU launch delay for Tecfidera on patent issues

In a filing with the Securities and Exchange Commission, US biotech firm Biogen Idec (Nasdaq: BIIB) said it is seeking to launch its multiple sclerosis drug candidate Tecfidera (BG-12; dimethyl fumarate) in the European Union with patent and regulatory data protection. On May 29, 2013, Biogen Idec was granted a European patent that extends until 2028 and covers the expected EU Tecfidera label dose of 480mg, the company noted.

Biogen Idec believes that Tecfidera, which recently gained backing from a European Medicines Agency advisory panel (The Pharma Letter March 25), is also entitled to regulatory data protection in the EU and is working to make Tecfidera’s  regulatory data protection clearer to all parties prior to launch. This is expected to delay the launch of Tecfidera in the EU until the second half of 2013, the company stated.

Earlier this month, Tecfidera was approved by the US Food and drug Administration (TPL May 21). Jefferies & Co analyst Thomas Wei recently forecasts that Tecfidera will achieve global sales of $2 billion in 2015 while other analyst forecast revenues of as much as $3.4 billion in 2017. According to a recent Wells Fargo report, initial US sales of Tecfidera have exceeded those of Novartis' Gilenya (fingolimod) and Sanofi's Aubagio (teriflunomide).