Toray Industries, Inc. (head office: Chuo-ku, Tokyo; President: Akihiro Nikkaku; hereinafter referred to as “Toray”) and Toray Medical Co., Ltd. (head office: Chuo-ku, Tokyo; President: Toshio Ohshima; hereinafter referred to as “Toray Medical”) announced today that the companies signed a license agreement on joint development, marketing and manufacturing rights of nalfurafine hydrochloride (generic name; hereinafter referred to as the “Agent”), which was being developed by Toray, for the improvement of pruritus in chronic liver disease patients. Subsequently, Toray Medical has submitted a new drug application to the Ministry of Health, Labour and Welfare in Japan.
Pruritus in chronic liver disease patients, even without inflammatory on the skin, is known to cause generalized and severe pruritus. Some patients suffer from lack of sleep at night due to severe itching, which worsens their quality of life (QOL). Although multiple factors are believed to be affecting the pruritus in chronic liver disease patients, the exact cause is yet to be clarified. Existing treatments for itching (antihistamines and anti-allergic agents) fail to sufficiently control this pruritus and development of effective treatments has been awaited.
The Agent is a highly selective kappa opioid receptor agonist created by Toray and controls itching based on a mechanism that is different from antihistamines and anti-allergy drugs. It, therefore, is expected to be effective on pruritus which cannot be controlled by existing treatments.
Toray Medical, in its pharmaceutical business, currently distributes the natural-type interferon beta preparation “Feron” for the treatment of viral liver diseases and some types of brain tumors and skin cancer. The company aims to enhance its product pipeline through licensing of this agent and expand the sales bases of the pharmaceutical business. For distribution of this Agent, Toray Medical basically agreed with OrphanPacific, Inc. (head office: Shinagawa-ku, Tokyo; President: Akio Tsubokura) regarding implementation of co-promotion and post-marketing surveillance operation, and the two companies are currently discussing the details.
