Biogen Idec Inc.
) recently announced that it expects a delay in the EU launch of
its oral multiple sclerosis treatment, Tecfidera, as it continues
to work on strengthening patent protection for the candidate.
Although Tecfidera is protected by a European patent until 2028,
Biogen believes that Tecfidera is also entitled to regulatory
The company is currently working on the regulatory data
protection situation and therefore expects to launch Tecfidera in
the EU in the second half of this year.
We note that a response regarding Tecfidera's approval status
in the EU should be out this quarter. In Mar 2013, the Committee
for Medicinal Products for Human Use (CHMP) issued a positive
opinion regarding the approval of Tecfidera. Biogen is looking to
get Tecfidera approved in the EU as a first-line oral treatment
for adults with relapsing-remitting multiple sclerosis
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.
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. Tecfidera gained
approval in the US in late Mar 2013 and is already doing
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
Other companies that look interesting include
Alexion Pharmaceuticals, Inc.
Anika Therapeutics Inc.
). While Alexion and Alkermes are Zacks Rank #2 stocks, Anika is
a Zacks Rank #1 (Strong Buy) stock.
ALKERMES INC (ALKS): Free Stock Analysis
ALEXION PHARMA (ALXN): Free Stock Analysis
ANIKA THERAPEUT (ANIK): Free Stock Analysis
BIOGEN IDEC INC (BIIB): Free Stock Analysis
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