Completes Post-Marketing Surveillance on All Patients with Refractory Uveoretinitis in Behcet's Disease REMICADE® I.V. Drip Infusion Anti-TNFα Monoclonal Antibody 100

August 18, 2010 Press Release Mitsubishi Tanabe Pharma Corporation Completes Post-Marketing Surveillance on All Patients with Refractory Uveoretinitis in Behcet's Disease REMICADE® I.V. Drip Infusion Anti-TNFα Monoclonal Antibody 100 Osaka, Japan, August 18, 2010---Mitsubishi Tanabe Pharma Corporation (President & CEO: Michihiro Tsuchiya) announced today that the Company has completed post-marketing surveillance of REMICADE® I.V. Drip Infusion 100, anti-TNFα monoclonal antibody, on all patients with refractory uveoretinitis in Behcet's disease. Behcet's disease is an intractable systemic inflammatory disease characterized by aphthous oral ulcer on the mucous membrane, dermatitis, ulcer on the vulva, and uveoretinitis. Repeated uveoretinitis episodes of relapse and recovery lead to irreversible damage to the optic nerve and retina, and in serious cases often lead to vision loss. The cause of Behcet's disease is unknown; no basic remedy has yet been established. It is designated an intractable disease and is studied in the Specified Disease Treatment Research Program of the Ministry of Health, Labor and Welfare (MHLW). In January 2007, the Company acquired the world’s first approval for REMICADE® for an additional indication of refractory uveoretinitis in Behcet's disease (limited to cases in which conventional remedies have not been effective) from MHLW. Subsequently, the Company has conducted post-marketing surveillance on all patients with refractory uveoretinitis in Behcet's disease to confirm its safety and efficacy of REMICADE®. The results of the surveillance were examined by the First Committee on New Drugs of the Pharmaceutical Affairs and Food Sanitation Council; and the condition imposed on approval was lifted. Throughout the surveillance, serious side effects were observed in 4.5%. This safety profile is very similar to that in other indications of REMICADE®. The surveillance confirmed that REMICADE® is safe for patients with refractory uveoretinitis in Behcet's disease for whom conventional remedies have not been effective. Moreover, in more than 83% of the patients who were in follow-up for two years, symptoms improved. It has been reconfirmed that the treatment with REMICADE® controls ocular attacks and augments the retention of patient’s visual function. Mitsubishi Tanabe Pharma Corporation will promote the proper use of REMICADE® by providing these accumulated data on efficacy, safety and usage, and contribute to improve the QOL (Quality of Life) of patients with refractory uveoretinitis in Behcet's disease. <Media enquiry> Corporate Communications Department Phone: +81 6-6205-5211

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