Roche's RA drug posts blockbuster results in Phase III

A late-stage study of Roche's rheumatoid arthritis drug ocrelizumab has hit its primary endpoint in a group of hard-to-treat patients. The drug combined with methotrexate, the standard therapy for RA, significantly improved the signs and symptoms of the disease at 24 and 28 weeks. But researchers also flagged a higher rate of serious infections among the drug combo crowd, noting that a safety analysis is ongoing.

"RA is a severe, chronic disease which causes painful inflammation of the joints and can lead to deformity and disability. We believe ocrelizumab has the potential to offer a differentiated treatment option for these patients," says William Burns, CEO of the pharmaceuticals division of Roche, in a statement. Data from three other late-stage trials will be unveiled in the first half of 2010 and Kepler Capital Markets analyst Martin Voegtli expects the company to file for approval of the drug--a potential billion-dollar seller--next year as well.

Ocrelizumab, which had been the subject of a contract dispute between Genentech and Biogen Idec centering on the development of follow-up drugs to Rituxan, targets CD20 positive B cells and has been developed specifically for use in autoimmune diseases such as RA.

- here's Roche's press release
- here's the report from Reuters