) 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
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.
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
) Aubagio and
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
) looks more attractive with a Zacks Rank #1 (Strong Buy).
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