) recently announced positive top-line data on its phase III
multiple sclerosis candidate, peginterferon beta-1a. Results from
the ADVANCE study showed that peginterferon beta-1a met the
primary endpoint as well as secondary endpoints.
Two doses (once in two weeks and once in four weeks) of
peginterferon beta-1a were compared to placebo in the study that
was conducted to evaluate the safety and efficacy of the
candidate in patients suffering from relapsing-remitting multiple
Both dosing regimens met the primary endpoint of annualized
relapse rate (ARR) at one year. While ARR reduction was 35.6% in
the two-week regimen, the four-week regimen saw a 27.5% reduction
Secondary endpoints included reduction of the risk of 12-week
confirmed disability progression as measured by the Expanded
Disability Status Scale (38% for both dosing arms), reduction in
the proportion of patients who relapsed (39% the two-week dosing
arm and 26% in the four-week dosing arm) and reduction in the
number of new or newly enlarging T2-hyperintense lesions on brain
MRI scans (67% in the two-week dosing arm and 28% in the
four-week dosing arm). Biogen said that safety and tolerability
profiles were favorable in both arms.
Biogen intends to present data from this study at the upcoming
annual meeting of the American Academy of Neurology (AAN) in
March. Meanwhile, with these positive results in hand, the
company should be able to go ahead with its plans of filing for
US and EU approval this year.
We are pleased with Biogen's progress with its multiple
sclerosis (MS) pipeline. A less frequent dosing schedule (not
more than 26 doses in a year) and a favorable safety and efficacy
profile should work in peginterferon beta-1a's favor once it is
Biogen is the market leader in therapies for the treatment of
multiple sclerosis. We believe the company will continue to
retain a leading position in the multiple sclerosis market.
Biogen has an important regulatory event coming up with an FDA
decision on its oral multiple sclerosis candidate, BG-12,
expected in late March. We believe BG-12 could become a leader in
the oral multiple sclerosis market once launched. Biogen has
another multiple scelrosis candidate, daclizumab, in development
Biogen currently carries a Zacks #3 Rank (Hold). Biopharma
stocks that currently look attractive include companies like
) - both companies are Zacks Rank #1 (Strong Buy) stocks.
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