Eisai Company, Ltd. and Toyama Chemical Company Receive Approval to Market Anti-rheumatic Agent Iguratimod in Japan

Published: Jun 29, 2012

Tokyo, Jun 29, 2012 (JCN Newswire via COMTEX) -- Eisai Co., Ltd. and Toyama Chemical Co., Ltd. announced today that they have received approval from Japan's Ministry of Health, Labour and Welfare to market iguratimod (generic name; development code: T-614) for the treatment of rheumatoid arthritis.

Iguratimod, originally discovered by Toyama Chemical, is a novel disease modifying anti-rheumatic drug (DMARD) jointly developed in Japan by Eisai and Toyama Chemical based on a co-development and license agreement previously concluded between the two companies.

In a clinical study of iguratimod administered as a monotherapy in patients with rheumatoid arthritis, the agent demonstrated superiority over placebo and non-inferiority compared to an existing DMARD (salazosulfapyridine). In addition, in a trial of iguratimod in combination with methotrexate ("MTX"), the standard of care, conducted in rheumatoid arthritis patients who did not achieve satisfactory benefit with MTX alone, patients who were administered a combination of the two agents demonstrated favorable tolerability as well as significant improvements compared to those treated with placebo (MTX-only arm) in the study's primary endpoint of ACR20 response rate at Week 24. Out of all the orally-administered anti-rheumatic drugs currently approved in Japan, iguratimod is the first agent evaluated in domestic clinical trials to demonstrate efficacy as an add-on therapy to MTX in patients who did not achieve satisfactory benefit with MTX alone.

Once listed on Japan's National Health Insurance (NHI) drug price list, iguratimod will be sold by Eisai and Taisho Toyama Pharmaceutical Co., Ltd. (headquarters:Tokyo)(president:Akira Ohira) under the brand names Careram(R) Tablets 25 mg and KOLBET(R) Tablets 25 mg, respectively, with both companies working to market the product and provide information on its proper use.

Following launch, the two companies will also conduct a special use results survey (all-case surveillance) in all patients who are administered the drug until a pre-determined number of patients has been reached.

By providing iguratimod as a new option for the pharmacological treatment of rheumatoid arthritis, Eisai and Toyama Chemical believe that they will be able to make further contributions to address the diversified needs and improve the quality of life of rheumatoid arthritis patients.

About Eisai

Eisai Co., Ltd. (adr:ESALY) is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: integrative neuroscience, including neurology and psychiatric medicines; integrative oncology, which encompasses oncotherapy and supportive-care treatments; and vascular/immunological reaction. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide healthcare system. For more information about Eisai Co., Ltd., please visit www.eisai.com .


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Eisai Co., Ltd.


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Toyama Chemical Co., Ltd.


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