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Toyama Chemical Co., Ltd.
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Toyama Chemical Co., Ltd. (Headquarters: Tokyo, President: Masuji Sugata) and °®¶¹´«Ã½. (Headquarters: Tokyo, President and CEO: Haruo Naito) announced today that the companies have decided to withdraw temporarily the New Drug Application (NDA) of anti-rheumatic drug T-614 (generic name: iguratimod), which have been developed jointly by the two companies in Japan. The NDA of T-614 was submitted to the Japanese Ministry of Health, Labour and Welfare by the companies on September 24, 2003. Subsequent interviews with the Pharmaceuticals and Medical Devices Agency as well as the recent shift in treatment of rheumatoid arthritis have made the companies decide to conduct an additional study for data on efficacy and safety of T-614 when used as an add-on therapy to the standard treatment. The companies will proceed with the additional study swiftly, and aim to resubmit the NDA in FY2011.

T-614 is a novel Disease-Modifying Anti-Rheumatic Drug (DMARD) originally discovered by Toyama Chemical Co., Ltd. Through development of this new drug, the companies aim to bring a new treatment option for rheumatoid arthritis, thereby addressing the diversified needs of patients with the disease and making further contributions to improving their quality of life.