Biogen Idec (BIIB) recently announced the acceptance of its regulatory filings in the U.S. and E.U. for its oral multiple sclerosis candidate, BG-12. The U.S. Food and Drug Administration (FDA) has granted standard review to the candidate, which means a response should be out in late 2012/early 2013.

The regulatory filings were based on data from the phase III DEFINE and CONFIRM studies which showed that treatment with BG-12 led to a significant reduction in disease activity in multiple sclerosis patients. Moreover, the candidate had a favorable safety and tolerability profile.

Biogen is also seeking approval for BG-12 in Canada and Switzerland.

Biogen is the market leader in therapies for the treatment of multiple sclerosis (MS). We believe the company will continue to retain a leading position in the MS market. Biogen is working on consolidating its position in the MS market and has an impressive late-stage pipeline of drugs including BG-12.

Meanwhile, Biogen and partner Abbott (ABT) moved their MS candidate, daclizumab, into a two-year phase III study (DECIDE) in July 2010. Daclizumab is being evaluated as a once-monthly or bi-weekly subcutaneous injection for relapsing-remitting MS. PEGylated interferon rounds up Biogen’s late-stage MS pipeline. PEGylated interferon is currently in a phase III study (ADVANCE).

Our Take

We believe BG-12 could become a leader in the oral MS market once launched. BG-12 should help drive long-term growth. Biogen has been facing additional competition in the multiple sclerosis market in the form of Novartis’ (NVS) Gilenya. Moreover, several companies besides Biogen are working on bringing an oral multiple sclerosis drug to market.

We currently have a Neutral recommendation on Biogen, which carries a Zacks #3 Rank (short-term ‘Hold’ rating).

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