Standard Review for Biogen's BG-12

Biogen Idec (BIIB - Analyst Report) 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 - Analyst Report) 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 - Snapshot Report) 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).