) recently announced additional patent protection for its oral
multiple sclerosis candidate, Tecfidera (dimethyl fumarate). The
company said that the US Patent and Trademark Office (USPTO) has
granted US Patent No. 8,399,514 to Tecfidera.
The recently issued patent, covering the daily dosing regimen
of Tecfidera 480 mg, is set to expire in 2028. We note that
sometime back, the European Patent Office had 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.
Tecfidera is currently under FDA review with a response
expected shortly. The new drug application (NDA) for Tecfidera
was based on data from the phase III DEFINE and CONFIRM studies
which 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
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). While 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
Other stocks that currently look more attractive include
). All three are Zacks Rank #1 (Strong Buy) stocks.
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