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FUJIFILM : Transfer of rights to anti-rheumatic agent KOLBETŪ tablets 25mg in Japan (Toyama Chemical)

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10/13/2017 | 04:39 am

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)

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).

2. About marketing authorization holder and marketing of KOLBET Tablets 25 mg

Until December 31, 2017

From January 1, 2018 and onwards (scheduled)

Marketing Authorization Holder

Toyama Chemical Co., Ltd.

Eisai Co., Ltd.

Marketing

Taisho Toyama Pharmaceutical Co., Ltd.

Eisai Co., Ltd.

3. About Eisai Co., Ltd.
Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as 'giving first thought to patients and their families and to increasing the benefits health care provides,' which we call our human health care (hhc) philosophy. With approximately 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to address unmet medical needs, with a particular focus in our strategic areas of Oncology and Neurology.
As a global pharmaceutical company, our mission extends to patients around the world through our investment and participation in partnership-based initiatives to improve access to medicines in developing and emerging countries. For more information about Eisai Co., Ltd., please visit www.eisai.com.

4. 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.jp/en/.

5. 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/.

Fujifilm Holdings Corporation published this content on 13 October 2017 and is solely responsible for the information contained herein.
Distributed by Public, unedited and unaltered, on 13 October 2017 02:39:08 UTC.

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