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Biogen Delays EU Launch of Tecfidera

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Biogen Idec Inc. (BIIB - Free Report) recently announced that it expects a delay in the EU launch of its oral multiple sclerosis treatment, Tecfidera, as it continues to work on strengthening patent protection for the candidate. Although Tecfidera is protected by a European patent until 2028, Biogen believes that Tecfidera is also entitled to regulatory data protection.

The company is currently working on the regulatory data protection situation and therefore expects to launch Tecfidera in the EU in the second half of this year.

We note that a response regarding Tecfidera’s approval status in the EU should be out this quarter. In Mar 2013, the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion regarding the approval of Tecfidera. Biogen is looking to get Tecfidera approved in the EU as a first-line oral treatment for adults with relapsing-remitting multiple sclerosis (RRMS).

According to the CHMP, Tecfidera has a favorable benefit-to-risk balance based on the quality, safety and efficacy data submitted by Biogen. Results from studies showed that treatment with Tecfidera led to a significant reduction in disease activity in multiple sclerosis patients. Moreover, the candidate had a favorable safety and tolerability profile.

Biogen is the market leader in therapies for the treatment of multiple sclerosis. The company’s key products include Avonex and Tysabri. Biogen has been working on strengthening its position in the multiple sclerosis market. We believe Tecfidera could become a leader in the oral multiple sclerosis market. Tecfidera gained approval in the US in late Mar 2013 and is already doing well.

Biogen currently carries a Zacks Rank #2 (Buy). Avonex and Tysabri should continue contributing significantly to sales. Tecfidera should help drive long-term growth. We are also encouraged by the company’s progress with its hemophilia candidates.

Other companies that look interesting include Alexion Pharmaceuticals, Inc. (ALXN - Free Report) , Alkermes plc (ALKS - Free Report) and Anika Therapeutics Inc. (ANIK - Free Report) . While Alexion and Alkermes are Zacks Rank #2 stocks, Anika is a Zacks Rank #1 (Strong Buy) stock.

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