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Friday 25 January 2008

Genentech and Biogen Idec Announce Positive Results from a Phase III Trial of Rituxan in Patients with Rheumatoid Arthritis Who Inadequately Responded to Methotrexate

By: Business Wire

Genentech, Inc. (NYSE:DNA) and Biogen Idec (Nasdaq:BIIB) announced today that a Phase III clinical study of Rituxan(R) (rituximab) in biologic-naive patients met its primary endpoint of a significantly greater proportion of Rituxan-treated patients achieving an American College of Rheumatology (ACR) 20 response at week 24, compared to placebo. The study enrolled patients with moderately-to-severely active rheumatoid arthritis (RA) who had an inadequate response to prior treatment with methotrexate (MTX), a disease modifying antirheumatic drug (DMARD).

In this study, known as SERENE, patients who received a single treatment course of two infusions of either 500 mg or 1000 mg of Rituxan in combination with a stable dose of MTX displayed a statistically significant improvement in ACR20 scores compared to patients who received placebo in combination with MTX. Although the study was not designed to compare the Rituxan doses, treatment efficacy appears to be similar between both Rituxan doses. Further analyses of the data are ongoing and will be submitted for presentation at an upcoming medical meeting.

"While use of Rituxan with MTX is well-established in RA patients who have had an inadequate response to anti-TNF therapy, this is the first Phase III study demonstrating that Rituxan improved symptoms of RA in patients who had not previously been treated with a biologic therapy," said Hal Barron, M.D., Genentech's senior vice president, Development and chief medical officer. "These findings support the potential use of Rituxan earlier in the course of treatment for this debilitating disease."

"These data provide further support for B-cell therapy in RA," said Evan Beckman, M.D., Biogen Idec's senior vice president of Immunology Research and Development. "We look forward to sharing the full analysis results from SERENE with the medical community and the FDA."

A preliminary analysis of the data did not reveal any unexpected safety signals. The incidence of overall adverse events and serious adverse events were comparable between Rituxan and placebo treatment groups. The rates of overall infections and serious infections were comparable between Rituxan and placebo treatment groups. There were more infusion-related reactions with the first Rituxan infusion, which were primarily mild to moderate in severity and reversible with medical intervention. There were no serious infusion reactions with Rituxan. The companies continue to monitor the long-term safety of Rituxan treatment.

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