Biogen Idec (BIIB) recently received good news with the Committee for Medicinal Products for Human Use (CHMP) issuing a positive opinion regarding the approval of the company’s oral multiple sclerosis candidate, 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.
A decision regarding the EU approval of Tecfidera should be out in the second quarter of 2013. With the CHMP issuing a positive opinion, chances of Tecfidera’s gaining EU approval are high. We note that Sanofi’s (SNY) Aubagio (once-daily oral treatment of relapsing-remitting multiple sclerosis) also received a positive opinion from the CHMP.
Meanwhile, a response regarding Tecfidera’s approval status in the US should be out within the next few days. 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 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 once launched.
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. We expect investor focus to remain on the FDA’s decision regarding the approvability of Tecfidera.
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