Eisai Co., Ltd., Toyama Chemical Co., Ltd. of the Fujifilm Group and Taisho Pharmaceutical Co., Ltd. have declared 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 holds the rights to market the agent, which it exercises through Taisho Toyama Pharmaceutical Co., Ltd.
Transfer of the marketing authorization for the agent from Toyama Chemical to Eisai and transfer of the marketing activities from Taisho Pharmaceutical and TaishoToyama to Eisai is 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 AntiRheumatic 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.
About anti-rheumatic agent KOLBET Tablets 25 mg (generic name: iguratimod)
Indications and Usage: Rheumatoid arthritis
Dosage and Administration: The recommended adult dosage of iguratimod is one 25 mg tablet taken orally once daily after breakfast for at least four weeks, after which the dosage should be increased to one 25 mg tablet taken twice daily (after breakfast and after dinner).
About Toyama Chemical Co., Ltd.
Toyama Chemical Co., Ltd. is a core company of the Fujifilm Group responsible for the “treatment” area of Fujifilm’s healthcare business. It works to develop innovative new medicines in its primary focus areas of infectious diseases, neurological diseases, and inflammatory diseases. By producting stable new drug candidates of an international standard and combining them with Fujifilm’s technology, it aims to further strengthen its R&D and production capibilities. Toyama Chemical specializes in pharmaceutical research and development, and strives to contribute to the further development of global health care through new drug development. For more information about Toyama Chemical Co., Ltd., please visit www.toyama-chemical.co.
About Taisho Pharmaceutical Co., Ltd.
Taisho Pharmaceutical Co., Ltd. conducts research, development, manufacturing and marketing of over-the-counter (OTC) medicine, special health foods, food products, medical products, and hygiene products (self-medication business) as well as research, development, manufacturing and marketing of ethical pharmaceuticals (prescription pharmaceutical business). While leading the market with top-share OTC medicines including Lipovitan D, Pavulon, and RiUP, Taisho Pharmaceutical is enhancing its development capabilities for new prescription medicines. While exploiting the synergy between these two businesses, it seeks to contribute to the realization of a healthier and more prosperous life that everyone desires. For more information about Taisho Pharmaceutical Co., Ltd., please visit www.taisho.co.jp/en/.
Eisai Co., Ltd. (TSE:4523; 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.