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Transfer of rights to anti-rheumatic agent KOLBET® tablets 25mg in Japan
|October 13, 2017|
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”), Toyama Chemical Co., Ltd. of the Fujifilm Group (Headquarters: Tokyo, President: Junji Okada, “Toyama Chemical”) and Taisho Pharmaceutical Co., Ltd. (Headquarters: Tokyo, Chief Executive Officer: Shigeru Uehara, “Taisho Pharmaceutical”) announced today that Eisai will acquire the marketing authorization and take over the marketing activities for anti-rheumatic agent KOLBET® Tablets 25mg (generic name: iguratimod), based on an agreement between the companies. Currently, Toyama Chemical holds the marketing authorization and manufactures the agent, while Taisho Pharmaceutical hold the rights to market the agent, which it exercises through Taisho Toyama Pharmaceutical Co., Ltd. (Headquarters: Tokyo, President: Kenichi Fujita, “TaishoToyama”).
Transfer of the marketing authorization for the agent from Toyama Chemical to Eisai and transfer of the marketing activites from Taisho Pharmaceutical and TaishoToyama to Eisai are scheduled to take place on January 1, 2018. Toyama Chemical will continue to manufacture the agent.
Iguratimod is an active ingredient developed by Toyama Chemical. It is a Disease Modifying Anti-Rheumatic Drug (DMARD) which exhibits an anti-rhematic effect mainly by suppressing production of immunoglobulin and inflammatory cytokines. Iguratimod demonstrated efficacy as monotherapy in a domestic clinical study for rheumatoid arthritis patients, and in a combination study with methotrexate (MTX), the standard of care, it was the first orally-administered anti-rheumatic drug in Japan to demonstrate efficacy as an add-on therapy to MTX in patients who responded inadequately to MTX monotherapy.
Iguratimod is sold by Eisai and Taisho Toyama under the brand names Careram® Tablets 25 mg and KOLBET® Tablets 25 mg, respectively, with both companies working to market the product and provide information on its proper use. Based on this transfer of the marketing authorization and marketing activities, Eisai will be the sole distributor of iguratimod in Japan.
Eisai, Toyama Chemical, Taisho Pharmaceutical and TaishoToyama will cooperate to ensure the smooth transfer of the marketing authorization and marketing activities for KOLBET tablets.
≪Notes to editors≫
1. About anti-rheumatic agent KOLBET® Tablets 25 mg (generic name: iguratimod)
2. About marketing authorization holder and marketing of KOLBET® Tablets 25 mg
3. About Eisai Co., Ltd.
4. About Toyama Chemical Co., Ltd.
5. About Taisho Pharmaceutical Co., Ltd.