Positive Data on Biogen's Plegridy
Biogen Idec (BIIB) 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.
Detailed Results
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 (RRMS).
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.
Our Take
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 AbbVie (ABBV).
Biogen currently carries a Zacks Rank #2 (Buy). Other stocks that currently look more attractive include companies like Athersys, Inc. (ATHX), and Cytokinetics, Inc. (CYTK). Both are Zacks Rank #1 (Strong Buy) stocks.
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