Biogen Idec (BIIB) 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.
Detailed Results
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 sclerosis (RRMS).
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 in ARR.
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.
Our Take
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 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, 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 with AbbVie (ABBV).
Biogen currently carries a Zacks #3 Rank (Hold). Biopharma stocks that currently look attractive include companies like Alkermes (ALKS) and Medivation (MDVN) – both companies are Zacks Rank #1 (Strong Buy) stocks.
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