) 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
) Aubagio (once-daily oral treatment of relapsing-remitting
multiple sclerosis) also received a positive opinion from the
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
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.
Other stocks that currently look more attractive include
). Both are Zacks Rank #1 (Strong Buy) stocks.
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