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Mar. 03, 2015Print(PDF/114KB)Products

Toray Applies for Japanese Approval of Additional Indication of Pruritus Treatment REMITCH CAPSULES 2.5 μg and Notice Regarding Promotion Tie-up

Toray Industries, Inc. (head office: Chuo-ku, Tokyo; President: Akihiro Nikkaku; hereinafter referred to as “Toray”) today announced that on March 3, 2015 it filed REMITCH® CAPSULES 2.5 μg (generic name: nalfurafine hydrochloride; hereinafter referred to as the “Agent”) for an additional indication of improvement of pruritus in chronic liver disease patients (hereinafter referred to as the “new indication”) in Japan. It has already received manufacturing and marketing approval by Toray and is promoted and distributed by Torii Pharmaceutical Co., Ltd. (head office: Chuo-ku, Tokyo; President: Shoichiro Takagi; hereinafter referred to as “Torii Pharmaceutical”) as a treatment of pruritus in hemodialysis patients in the country.

In addition, Japan Tobacco Inc. (head office: Minato-ku, Tokyo; President: Mitsuomi Koizumi), Torii Pharmaceutical and Sumitomo Dainippon Pharma Co., Ltd. (head office: Osaka; President: Masayo Tada; hereinafter referred to as “Sumitomo Dainippon Pharma”) have agreed that Sumitomo Dainippon Pharma would promote the Agent’s new indication, and Torii Pharmaceutical and Sumitomo Dainippon Pharma signed a promotion agreement (hereinafter referred to as the “agreement”).

Under the terms of the agreement, once Toray obtains approval for the new indication of the Agent, Sumitomo Dainippon Pharma will provide drug information regarding the new indication at medical institutions, while Torii Pharmaceutical will continue to receive supply of the Agent from Toray and distribute it accordingly. The drug information regarding the treatment of pruritus in hemodialysis patients will continue to be provided by Torii Pharmaceutical.

The Agent is the world’s first highly selective kappa opioid receptor agonist created by Toray and has been distributed in Japan by Torii Pharmaceutical as a treatment of pruritus in hemodialysis patients since March 2009. It controls itching based on a mechanism that is different from antihistamines and anti-allergy drugs and, therefore, is expected to be effective on pruritus which cannot be controlled by existing treatments.

The four companies hope to significantly contribute to the treatment of pruritus in chronic liver disease patients by offering a new treatment option.

Reference

Pruritus experienced by chronic liver disease patients, even if non-inflammatory on the skin, is known to cause severe itching all over the body. Although multiple factors are believed to be affecting the pruritus experienced by such patients, the exact cause is yet to be identified. Existing treatments for itching fail to sufficiently control this pruritus and development of effective treatments have been sought.

Company Profiles

Toray Industries, Inc.
Head office: 1-1, Nihonbashi-Muromachi 2-chome, Chuo-ku, Tokyo
President: Akihiro Nikkaku
Capitalization: 147,873 million yen (as of the end of December, 2014)

Japan Tobacco Inc.
Head office: 2-1, Toranomon 2-chome, Minato-ku, Tokyo
President: Mitsuomi Koizumi
Capitalization: 100,000 million yen (as of the end of December, 2014)

Torii Pharmaceutical Co., Ltd.
Head office: Torii Nihonbashi Building, 4-1, Nihonbashi-Honcho 3-chome, Chuo-ku, Tokyo
President: Shoichiro Takagi
Capitalization: 5,190 million yen (as of the end of December, 2014)

Sumitomo Dainippon Pharma Co., Ltd.
Head office: [Osaka] 6-8, Doshomachi 2-chome, Chuo-ku, Osaka, Osaka
[Tokyo] 13-1, Kyobashi 1-chome, Chuo-ku, Tokyo
President: Masayo Tada
Capitalization: 22,400 million yen (as of the end of December, 2014)