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Roche: Actemra Approved In Japan In Rheumatoid Arthritis

Nikkei English News - Apr. 16, 2008
http://www.therapeuticsdaily.com/news/article.cfm?contenttype=sentryarticle&contentvalue=1765507&channelID=31

ZURICH -(Dow Jones)- Swiss drugmaker Roche Holding AG (RHHBY) said Wednesday that their alliance partner company Chugai Pharmaceutical (4519.TO) has received approval in Japan for the use of its innovative treatment, Actemra (tocilizumab), in patients suffering from rheumatoid arthritis (RA).

Actemra was approved by the Japanese authorities for the indication of rheumatoid arthritis (including prevention of structural damage of joints) and two forms of the disease that affect children, know as juvenile idiopathic arthritis and systemic-onset juvenile idiopathic arthritis.

Japan is the first market worldwide to get access to Actemra for the treatment of RA. The approval is based on compelling data from clinical trials conducted in Japan that showed Actemra was highly effective in controlling the symptoms and progression of this serious disease.

"Today's approval represents a significant milestone for rheumatologists and patients in Japan. The Japanese authorities have recognized that Actemra is a breakthrough drug which addresses an unmet medical need for patients suffering from the debilitating effects of this disease" said William Burns, CEO Roche Pharmaceuticals Division.

Actemra is the first of a new class of drug with a novel mechanism of action that brings new hope to RA patients. It is a humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody, which works by suppressing the activity of IL-6, an important trigger of the inflammatory process. This novel mode of action reduces inflammation of the joints and relieves the systemic effects of RA.

Since 2005, Actemra has been marketed in Japan for the treatment of patients with a rare auto-immume condition known as Castleman's disease. Actemra licence applications have also been filed for treatment of RA in the Unites States and the European Union in 2007, and are currently under review.

Company Web Site: http://www.roche.com

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