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EC approves Biogen's oral MS drug Tecfidera

Will compete with Novartis' Gilenya and Sanofi's Aubagio
Biogen Idec building

Almost one year after it was recommended by the European Medicines Agency (EMA) Biogen Idec's oral multiple sclerosis (MS) has been approved in the EU.

Usually it takes just three months from EMA recommendation to approval from the European Commission (EC) but Tecfidera was delayed in May last year when Biogen Idec said it needed to resolve patent and regulatory data protection issues.

These issues were settled in November last year when Biogen Idec won a battle to classify the active ingredient in the drug – dimethyl fumarate - as a New Active Substance (NAS).

This status provides additional patent protection, meaning Tecfidera is less vulnerable to legal challenges and the possibility of generic completion before its patent expires in 2028.

Biogen Idec said it intends to roll out the drug in EU countries in the coming weeks, adding additional markets to its existing presence in the US, Canada and Australia.

The company will be hoping to replicate its success in the US where it has become the country's number one prescribed oral therapy for relapsing forms of MS (RRMS) since its approval from the Food and Drug Administration (FDA) in March 2013.

As reported in the company's most recent financial statement, sales of Tecfidera in the third quarter of 2013 were $286m, putting the drug well on course to meet analyst expectations of $3bn per year at peak.

With the latest approval, sales should grow even faster, although Tecfidera will face stiff competition from the other two new oral MS drugs – Novartis' Gilenya (fingolimod) and Sanofi's Aubagio (teriflunomide) – both of which have already been approved in the EU and have established their own presence.

Nevertheless, Biogen Idec was confident of the drug's potential in this new market.

Terry O'Regan, VP and managing director of Biogen Idec in the UK & Ireland, said: “Biogen Idec, as a world leader in MS, is proud that we are able to bring a first-line oral agent to market with efficacy demonstrated through a robust clinical trials programme.”

He added the company was committed to making Tecfidera “available in the UK and Ireland as quickly as we possibly can".

5th February 2014

From: Sales

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