), well known for its strong presence in the multiple sclerosis
(MS) market, is facing a delay in the approval process for its MS
pipeline candidate, Plegridy. Biogen is looking to get Plegridy,
a subcutaneous pegylated interferon candidate, approved for
relapsing forms of multiple sclerosis (RMS).
The FDA informed the company that it is extending the review
period by three months. This means that a response from the FDA
should now be out in the second half of the year instead of
mid-14 as had been expected earlier. The agency did not ask
Biogen to conduct additional studies. The review period was
extended to provide additional time for the review to be
Plegridy is under review in the EU as well where a response
should be out in the second half of the year.
Biogen's MS portfolio consists of drugs like Avonex, Tysabri
and the recently launched oral MS treatment, Tecfidera. Tecfidera
is off to a strong start in the U.S. and already holds a leading
position in the oral MS market. We expect the drug to do well in
the EU too where it was launched recently.
Biogen is working on consolidating its position in the MS
market. In addition to Plegridy, Biogen has daclizumab in its MS
pipeline. Biogen and partner
) are conducting a two-year phase III study (DECIDE) on
daclizumab with results due later this year. Biogen is also
looking to expand Tysabri's label and is conducting a phase IIIb
study (ASCEND) in combination with daclizumab in patients with
secondary-progressive MS - results are expected in 2015.
The delay in Plegridy's approval date should not be a matter
of major concern. The important thing is that the FDA has not
asked for additional studies to be conducted.
Biogen is a Zacks Rank #3 (Hold) stock. Some better-ranked
stocks in the biotech sector include companies like
Gilead Sciences Inc.
Alexion Pharmaceuticals, Inc.
). Both carry a Zacks Rank #1 (Strong Buy).
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