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FDA Approves Biogen's Tecfidera

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Tecfidera, Biogen Idec’s (BIIB - Free Report) oral multiple sclerosis treatment, gained FDA approval recently for the first-line treatment of people with relapsing forms of multiple sclerosis. Biogen intends to launch the drug shortly.

Results from studies conducted with Tecfidera 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.

Our View

Tecfidera’s approval is a major boost for Biogen. Given the product’s efficacy and safety profile, we expect strong sales ramp up once it is launched. We are pleased to note that Tecfidera does not carry a black box warning.

Meanwhile, a decision regarding the EU approval of Tecfidera should be out in the second quarter of 2013. With the Committee for Medicinal Products for Human Use (CHMP) issuing a positive opinion, chances of Tecfidera’s gaining EU approval are high.

Moreover, sometime back, Biogen had announced that it has received additional patent protection for Tecfidera. The company said that the US Patent and Trademark Office (USPTO) granted US Patent No. 8,399,514, covering the daily dosing regimen of Tecfidera 480 mg. The recently issued patent is set to expire in 2028. The European Patent Office has also said that Biogen’s application for a patent covering the same dosing regimen of Tecfidera is allowable. This patent will also expire in 2028, once it is granted.

Biogen currently carries a Zacks Rank #2 (Buy). The company has a strong presence in the multiple sclerosis market. Its 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 once launched. Other players in this market include Sanofi’s (SNY - Free Report) Aubagio and Novartis’ (NVS - Free Report) Gilenya.

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.

Currently, Athersys, Inc. (ATHX - Free Report) looks more attractive with a Zacks Rank #1 (Strong Buy).

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