) recently presented full first-year phase III results on its
multiple sclerosis candidate, Plegridy (peginterferon
beta-1a). Results from the ADVANCE study, which were
initially reported in Jan 2013, showed that Plegridy met the
primary endpoint as well as secondary endpoints.
Plegridy was 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 sclerosis
Plegridy (dosed once in two weeks) met the primary endpoint of
annualized relapse rate (ARR) at one year. ARR reduction
was 36% compared to placebo.
Secondary endpoints included reduction of the risk of 12-week
confirmed disability progression as measured by the Expanded
Disability Status Scale (by 38%), reduction in the proportion of
patients who relapsed (by 39%) and reduction in the number of new
or newly enlarging T2-hyperintense lesions on brain MRI scans (by
67%) compared to placebo. The number of gadolinium-enhancing
(Gd+) lesions was reduced by 86% in the Plegridy arm.
These results were presented at the annual meeting of the
American Academy of Neurology. While a once-in-four weeks
dosing regimen of Plegridy was also evaluated in the study, the
once- every-two weeks dosing arm was more effective.
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 pipeline. A less frequent dosing schedule and a
favorable safety and efficacy profile should work in Plegridy's
favor once it is launched.
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, Tecfidera,
expected in the coming days. We believe Tecfidera could
become a leader in the oral multiple sclerosis market once
launched. Biogen has another multiple sclerosis candidate,
daclizumab, in development with
Biogen currently carries a Zacks Rank #2 (Buy). Other stocks
that currently look more attractive include companies like
). Both are Zacks Rank #1 (Strong Buy) stocks.
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