Approval for Additional Indication of Ulcerative Colitis for Remicade® I.V. Drip Infusion 100, Anti-Human TNF α Monoclonal-Antibody

June 18, 2010 For press release Mitsubishi Tanabe Pharma Corporation Approval for Additional Indication of Ulcerative Colitis for Remicade® I.V. Drip Infusion 100, Anti-Human TNF α Monoclonal-Antibody Osaka, Japan, June 18, 2010 ---Mitsubishi Tanabe Pharma Corporation (President & CEO: Michihiro Tsuchiya) announced today that the Company has received, as of June 18, 2010, approval for the additional indication of ulcerative colitis for Remicade® I.V. Drip Infusion 100 (generic name: infliximab), anti-human TNF-α monoclonal-antibody. Ulcerative colitis is an inflammatory bowel di sease with erosion (mucosa inflammation) and ulcer, occurring in the large intestinal mucosa. It causes frequent diarrhea, bloody stool and abdominal pain. Serious cases require surgery to remove the large intestine. The cause of the disease is unknown; no basic remedy has yet been established. The disease is designated as an intractable disease, and is studied in the Specified Disease Treatment Research Program of the Ministry of Health, Labor and Welfare. Many patients have anxiety regarding surgery, and difficulty in daily life due to stool-related symptoms. Their quality of life (QOL) is significantly deteriorated. In clinical studies involving patients with moder ate to severe ulcerative colitis who did not respond to conventional therapy, Remicade® showed significant efficacy in improving diarrhea, bloody stool, other symptoms and QOL. Healing of lesions in the large intestinal mucosa were observed, while reducing the number of surgeries. Remicade® has been used to treat more than 50,000 patients in Japan and more than 1.25 million patients around the world, with Crohn’s disease, rheumatoid arthritis, Behcet’s disease with refractory uveoretinitis Note), psoriasis (plaque psoriasis, psoriatic arthritis, pustular psoriasis, erythrodermic psoriasis) and ankylosing spondylitis, and has accumulated enough evidence on its efficacy and safety. We will promote the proper use of Remicade® by providing this reliable information, and contribute to improving the QOL of patients with ulcerative colitis. Note): The use of Remicade® for treating Behcet’s disease with refractory uveoretinitis is approved only in Japan. <<For Details, Contact the Following Section>> Corporate Communications Department. Tel +81-6+6205-5211

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