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News Release

FOR IMMEDIATE RELEASE
September 24, 2003

Toyama Chemical and Eisai Announce
NDA submission to the Ministry of Health, Labour and Welfare

Toyama Chemical Co., Ltd.
Eisai Co., Ltd.

Toyama Chemical and Eisai Announce
NDA submission to the Ministry of Health, Labour and Welfare


Toyama Chemical Co., Ltd. (Headquarters: Tokyo, President: Katsuhiko Nakano) and Eisai Co., Ltd. (Headquarters: Tokyo, President: Haruo Naito) announced today that they submitted a New Drug Application (NDA) to the Japan Ministry of Health, Labour and Welfare (MHLA) for the jointly developed anti-rheumatic drug, T-614.


T-614, originally discovered by Toyama Chemical, is a novel drug classified as DMARD (Disease-Modifying Anti-Rheumatic Drug). Clinical study results showed that T-614 is effective against rheumatoid arthritis regardless of degree and length of illness, or history of treatment. As a result, T-614 is expected to have a broad base of application, from first-time DMARD users to patients who have developed resistance to existing DMARD agents.


Phase III clinical development of T-614 started in 1998, based on the co-development and license agreement between Toyama Chemical and Eisai made on September 30, 1998. After the NDA approval, Taisho Toyama Pharmaceutical Co., Ltd. and Eisai Co., Ltd. are going to promote T-614 under a 2-brand, 2-channel scheme.


Contacts:
Toyama Chemical Co., Ltd.
Corporate Planning Department
Public Relations Group
03-5381-3818
Eisai Co., Ltd.
Public Relations Department
03-3817-5120

[Explanation of Terms]
1.Rheumatoid Arthritis (RA)
RA is a disease that affects multiple joints in the body and causes severe pain, inflammation and swelling in the joints involved. Left untreated over time, it can lead to deformation and functional impairment of joints. Although causes of RA are not entirely known, it is probably as a result of over-growth of synovial cells in the articular cavity due to microorganisms. Further, blood vessels of joints are increased, and leukocytes such as lymphocytes and macrophages start moving from blood vessels to synovial tissues of joints. Immune responses occur in the joints locally, and inflammatory response is followed by cytokine reaction caused by lymphocytes and macrophages. Consequently, destruction of cartilages and bones proceeds.
2.DMARD (Disease Modifying Anti-Rheumatic Drug)
DMARD is called Disease Modifying Anti-Rheumatic Drug as they are developed to control the essentials of RA. DMARD is expected to control immunological abnormalities that may cause inflammation of RA. Immunoregulation and immunosuppressive drugs also belong to this category. For example, main DMARD marketed in Japan are salazosulfapyridine and methotrexate.

Currently, treatments for RA include non-steroidal anti-inflammatory drugs (NSAID) for pain control; corticosteroids that improve range of joint movement by decreasing inflammation in RA; and DMARDs to control immunological abnormalities.