) recently announced the acceptance of its regulatory filings in
the U.S. and E.U. for its oral multiple sclerosis candidate, BG-12.
The U.S. Food and Drug Administration (FDA) has granted standard
review to the candidate, which means a response should be out in
late 2012/early 2013.
The regulatory filings were based on data from the phase III
DEFINE and CONFIRM studies which showed that treatment with BG-12
led to a significant reduction in disease activity in multiple
sclerosis patients. Moreover, the candidate had a favorable safety
and tolerability profile.
Biogen is also seeking approval for BG-12 in Canada and
Biogen is the market leader in therapies for the treatment of
multiple sclerosis (MS). We believe the company will continue to
retain a leading position in the MS market. Biogen is working on
consolidating its position in the MS market and has an impressive
late-stage pipeline of drugs including BG-12.
Meanwhile, Biogen and partner
) moved their MS candidate, daclizumab, into a two-year phase III
study (DECIDE) in July 2010. Daclizumab is being evaluated as a
once-monthly or bi-weekly subcutaneous injection for
relapsing-remitting MS. PEGylated interferon rounds up Biogen's
late-stage MS pipeline. PEGylated interferon is currently in a
phase III study (ADVANCE).
We believe BG-12 could become a leader in the oral MS market
once launched. BG-12 should help drive long-term growth. Biogen has
been facing additional competition in the multiple sclerosis market
in the form of
) Gilenya. Moreover, several companies besides Biogen are working
on bringing an oral multiple sclerosis drug to market.
We currently have a Neutral recommendation on Biogen, which
carries a Zacks #3 Rank (short-term 'Hold' rating).
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