Biogen Idec (BIIB) and Genentech Inc., a wholly owned member of the Roche Group (RHHBY), recently reported positive phase III results on their rheumatoid arthritis (RA) candidate, ocrelizumab.

Results from the study (STAGE) showed that the humanized anti-CD20 monoclonal antibody, when given in combination with methotrexate (MTX), met its primary endpoint of improving signs and symptoms in RA patients who were not getting an adequate response to MTX at either 24 or 48 weeks.

While these results were encouraging, there could be some concern regarding the safety profile of the candidate as the companies reported a higher percentage of serious infections in the pooled ocrelizumab groups when compared to the placebo group. Safety analyses from the study are ongoing and will be presented at an upcoming medical meeting.

The international, randomized, multi-center, three-arm, parallel-group, placebo controlled study was conducted in 1,015 patients with active RA with an inadequate response to prior treatment with MTX. Ocrelizumab is a second-generation Rituxan product, which, if developed successfully, could hit the market in the 2011?2012 timeframe.

Results from three ongoing phase III studies for the RA indication should be out in the first half of 2010. Once launched, the product will compete with currently available treatments such as Pfizer/Amgen’s (PFE)/(AMGN) Enbrel, Abbott’s (ABT) Humira and Johnson & Johnson/Merck’s (JNJ)/(MRK) Remicade.

If developed successfully, ocrelizumab could become a blockbuster once approved and launched. RA is a debilitating autoimmune disease that affects an estimated 1.3 million Americans, hindering daily activities. Ocrelizumab is also being studied in patients with multiple sclerosis. We currently have a Neutral recommendation on Biogen.

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