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Two Pivotal Phase III Studies for Roche's ACTEMRA(TM) (tocilizumab) Demonstrate Significant Improvement in Rheumatoid Arthritis Symptoms
Date:11/7/2007

arch on ACTEMRA Determining effIcacy after Anti-TNF FailureEs) and AMBITION (ACTEMRA versus Methotrexate double-Blind Investigative Trial In MONotherapy) are completed and have reported meeting their primary study endpoints as well. An additional Phase III trial is ongoing; this two-year study, called LITHE (TociLIzumab safety and THE prevention of structural joint damage), is expected to report one-year data later in 2008.

About ACTEMRA (tocilizumab)

ACTEMRA is the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody and represents a novel mechanism of action to treat RA. 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, prevent long-term structural damage and relieve certain systemic effects of RA such as decreased hemoglobin, fatigue and osteoporosis. The ACTEMRA clinical development program is designed to evaluate these clinical findings. The compound is not currently approved in the United States. In Japan, ACTEMRA was launched by Chugai in June 2005 as a therapy for Castleman's disease; in April 2006, additional indications for rheumatoid arthritis and systemic-onset juvenile idiopathic arthritis were also filed in Japan.

The most common adverse events reported in ACTEMRA global clinical studies are upper respiratory tract infections, headache, nasopharyngitis and hypertension. As with other disease modifying anti-rheumatic drugs, serious infections have been reported in some patients treated with ACTEMRA.

About Rheumatoid Arthritis

Rheumatoid arthritis is a progressive, systemic autoimmune disease characterized by inflammation of the membrane lining in the joints. This inflammation causes a loss of joint shape and function, resulting in pain, stiffness and swelling, ultimately leading to irreversible joint destruction and disability. Characteristics of RA include redness, swelling, pain and movement
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