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| |  Japan Approves Enbrel (Etanercept) for Treatment of Rheumatoid Arthritis MADISON, NJ -- January 25, 2005 -- Wyeth Japan and Takeda Pharmaceutical Company, Limited (Takeda Pharmaceutical) today announced that Enbrel® (etanercept) has been approved by the Japan Ministry of Health, Labour and Welfare (MHLW) for the treatment of rheumatoid arthritis (RA) in patients who had an inadequate response to existing therapies. As announced earlier, Enbrel in Japan will be co-promoted by both Wyeth and Takeda Pharmaceutical. "We are pleased with the approval decision and following pricing approval, we will make the product available to Japanese patients as soon as possible," says Rune Bremberg, President, Wyeth Japan. Enbrel is the only fully human, anti-TNF receptor approved to reduce the signs and symptoms of RA in patients who had an inadequate response to traditional disease-modifying antirheumatic medicines. The biological product can be used alone as a monotherapy and is administered twice weekly as a subcutaneous injection. Initially the product will be made available to medical institutions participating in an all-patient surveillance program. About Rheumatoid Arthritis Rheumatoid arthritis is a chronic and potentially disabling disorder that affects about 700,000 people in Japan. The serious rheumatic disease causes the body's immune system to attack the lining of the joints, resulting in pain and swelling and may lead to fatigue, disability, deformity, organ damage, or premature death if not managed effectively. In RA, the immune system attacks the body's own healthy cells, mistaking them for cells that don't belong. This causes inflammation in the lining and connective tissues of the joints. Generally, in Japan the disease affects about four times as many women as men. RA can develop at all ages including childhood; in most cases it develops between the ages of 25 and 50. About Enbrel Globally physicians have become familiar with the benefits and proven long-term profile of Enbrel. As of today, the product has been approved in more than 70 countries around the world, and has been used to treat more than 280,000 patients worldwide across various indications. Enbrel acts by binding TNF, one of the dominant inflammatory cytokines or regulatory proteins that play an important role in both normal immune function and the cascade of reactions causing the inflammatory process of rheumatoid arthritis. The binding of Enbrel to TNF renders the bound TNF biologically inactive, resulting in significant reduction in inflammatory activity. Additionally, Enbrel binds to lymphotoxin (LT)-alpha, another cytokine involved in the inflammatory process of RA.
SOURCE: Wyeth
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