Biogen Submits Plegridy BLA

Zacks

Biogen Idec (BIIB) recently submitted a Biologics License Application (:BLA) in the US for its multiple sclerosis candidate, Plegridy (peginterferon beta-1a). The company is looking to gain US Food and Drug Administration approval for Plegridy for relapsing forms of multiple sclerosis (:RMS).

The BLA submission was based on results from the first year of the two-year global phase III ADVANCE study. Plegridy was compared to placebo in the study. 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.

Biogen intends to file for EU approval shortly.

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 received a major boost with its oral multiple sclerosis drug, Tecfidera, gaining FDA approval. We believe Tecfidera could become a leader in the oral multiple sclerosis market. Biogen has another multiple sclerosis candidate, daclizumab, in development with AbbVie (ABBV).

Biogen is currently a Zacks Rank #3 (Hold) stock. Companies that look well-positioned include Anika Therapeutics Inc. (ANIK) and Alkermes plc (ALKS). While Anika is a Zacks Rank #1 (Strong Buy) stock, Alkermes is a Zacks Rank #2 (Buy) stock.

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