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Biogen wins extra patent protection for MS drug Tecfidera

Dosing patent provides exclusivity until 2028

Extra patent protection for Biogen's MS drug Tecfidera

Biogen Idec received a boost in the US when its investigational oral multiple sclerosis (MS) drug Tecfidera received a new patent, extending its exclusivity by eight years.

On top of current patents that protect the product from generic competition until 2020, the US Patent and Trademark Office granted additional protection for Tecfidera (dimethyl fumarate) to 2028 to address the specific dosing regimen of daily administration of 480mg of the medicine.

This twice-daily regimen is included in Biogen's marketing application to the US FDA for Tecfidera's use in the treatment of relapsing-remitting multiple sclerosis (RRMS).

According to Biogen's CEO Dr George Scangos, the additional patent protection to 2028 is “recognition of the remarkable innovation Tecfidera represents for the MS community”.

“The tremendous research investment required to study and validate the patented dosing regimen is an example of innovation that leads to meaningful benefits to patients,” he added.

The company said that a similar patent was also under review by the European Patent Office that would also extend Tecfidera's exclusivity to 2028 in the region.

Formerly known as BG-12, Tecfidera is one of several new oral MS drugs that mark a significant step forward in treatment of the condition.

The most successful so far is Novartis' Gilenya (fingolimod), which was approved in 2011, but Sanofi is catching up following the approval of Aubagio (teriflunomide) at the end of 2012.

The FDA is expected to complete its review of Tecfidera soon, and if approved, the drug would be the first MS treatment that affects the Nrf-2 pathway, which provides a way for cells in the body to defend themselves against inflammation.

Tecfidera has demonstrated positive results in phase III trials, and Biogen has a lot riding on the drug, especially considering the recent failure of investigational amyotrophic lateral sclerosis treatment (ALS) dexpramipexole.

20th March 2013

From: Sales, Regulatory



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