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ACTEMRA(R) (tocilizumab) Significantly Reduces Rheumatoid Arthritis Signs and Symptoms Regardless of Previous Therapy in Two New Global Studies
Date:6/13/2008

ate. Levels of C-reactive protein (CRP), a marker of inflammation and hemoglobin levels, showed significant and rapid improvement as early as two weeks in ACTEMRA (8 mg/kg) patients in the AMBITION trial, compared with patients treated with methotrexate alone.

"We are extremely pleased with these results which help us work toward establishing ACTEMRA as a new first-line biologic treatment, which blocks a different inflammatory target than current therapies. We are encouraged that we will soon be able to offer this new treatment option and meaningful benefit to those who need it the most -- the RA patients," said Lars Birgerson, M.D., Ph.D., Vice President, Global Head Medical Affairs, Roche.

About ACTEMRA (tocilizumab)

ACTEMRA is the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody. Studies suggest that reducing the activity of IL-6, one of several key cytokines involved in the inflammatory process, may reduce inflammation of the joints and relieve certain systemic effects of RA. The extensive clinical development program conducted by Roche includes five clinical studies and has enrolled more than 4,000 patients in 41 countries, including the United States. Five Phase III studies are completed and have reported meeting their primary endpoints. The LITHE trial evaluating ACTEMRA in RA is an ongoing two-year study and is expected to report complete data evaluating the effects of ACTEMRA on the inhibition of structural joint damage in 2009. ACTEMRA is awaiting approval in the United States and Europe.

ACTEMRA is part of a co-development agreement with Chugai, a Japanese company. In June 2005, ACTEMRA was launched by Chugai in Japan as a therapy for Castleman's disease; in April 2008, additional indications for rheumatoid arthritis, juvenile idiopathic arthritis and systemic-onset juvenile idiopathic arthritis were also approved in Japan.

The serious adverse events reported in ACTEMRA clinical trials were se
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SOURCE Roche
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1. Roche Submits Application for FDA Approval of ACTEMRA(R) for the Treatment of Rheumatoid Arthritis
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