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Toray and Orient EuroPharma reach Taiwan license agreement on antipruritic agent, TRK-820

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Oct. 22, 2014

Toray Industries, Inc.
Orient EuroPharma Co.,Ltd

Toray Industries, Inc. (head office: Chuo-ku, Tokyo; President: Akihiro Nikkaku; hereinafter referred to as “Toray”) and Orient EuroPharma Co.,Ltd. (head office: Taipei; Chairman & CEO: Peter Tsai; hereinafter referred to as “OEP”) announced today that the companies signed a licensing agreement for the antipruritic drug TRK-820 (Toray development code; generic name: nalfurafine hydrochloride) developed by Toray for treating hemodialysis pruritus, in Taiwan. The agreement enables OEP to develop and market the product exclusively in Taiwan.

TRK-820 is a highly selective kappa opioid receptor agonist and it has been sold as REMITCH® CAPSULES 2.5 µg for treating hemodialysis-related uremic pruritus in Japan since March 2009 (manufactured and marketing approval held by Toray; distributed by Torii Pharmaceutical Co., Ltd.; in alliance with Japan Tobacco Inc.).

Pruritus experienced by hemodialysis patients, though non-inflammatory, is generalized and severe. Also, histamine, a generally known substance for causing itching, is known to have less involvement with the itching. Some patients suffer from lack of sleep due to severe itching, which worsens their quality of life (QOL). In addition, scratching results in skin inflammation and infections, which aggravate systemic symptoms. It is well known that conventional antipruritic agents including antihistamines cannot fully suppress this itching.

In Taiwan, it is known that the prevalence and incidence rate of ESRD (End Stage Renal Disease) patients is relatively higher than other countries and there are high needs related to hemodialysis treatment. By licensing in TRK-820, OEP enhances its development pipeline in the renal disease area, which it is focusing on, and will actively drive forward its clinical development to bring a new therapeutic method to the hemodialysis patients suffering from pruritus in Taiwan as early as possible. Toray hopes to make contributions to relieve the pruritus of hemodialysis patients in Taiwan through this alliance.

The detailed features of TRK-820 are as listed in the appendix.

# # #

<Appendix>
1. TRK-820 features
TRK-820 is a novel selective κ (kappa) opioid receptor agonist having a different mechanism from existing antipruritic drugs such as antihistamines. The drug is thought to suppress the pruritus mediated by the opioid-related mechanism and hence is expected to be effective in treating itching that is resistant to existing treatments such as antihistamine drugs. It is also thought to significantly contribute to improvement in the quality of life (QOL) of hemodialysis patients.
2. Opioid receptors
Receptors are the molecules located on the cell membranes. When receptors are bound by medical compounds, a biological response is triggered. There are a wide variety of receptors in the human body and each of them has a different specificity to its binding compounds and pharmacological functions expressed by such bindings. An opiate is one such medical compound that binds to a receptor and expresses a response, and its receptors are known as opioid receptors. Whereas it was thought that there was only one type of opioid receptor when it was initially discovered, the subsequent evolution of the research in the area revealed that it is largely classified into three receptor types indicated as μ (mu), δ (delta) and κ (kappa).
3. Agonists
Pharmacological molecules which target receptors are divided into agonists and antagonists. An agonist activates or stimulates, and thereby induces either an increase or decrease in the biological activities by the cell.

〈Corporate profiles〉

■Toray Industries, Inc.
Head office: 1-1, Nihonbashi-Muromachi 2-chome, Chuo-ku, Tokyo
President: Akihiro Nikkaku
Website: http://www.toray.com/

Toray Industries, Inc. was established in 1926 as a manufacturer of chemical fiber rayon. Subsequently, it developed various advanced materials such as synthetic fibers, resins, films, carbon fibers, high-performance water treatment membranes, pharmaceuticals and medical supplies and developed and further cultivates the markets. In April 2011, it drafted and implemented the long-term corporate vision AP-Growth TORAY 2020 as a unified policy of its corporate activities in pursuit of becoming "a corporate group that continually increases revenues and profits." As its second stage, in April 2014, Toray embarked on the medium-term management program "Project AP-G2016" with focus on “expansion of businesses in growth business fields and regions.” The Toray Group currently has operations in 25 countries and regions. In addition, the life science field is part of the Intensively Developing and Expanding Businesses, which are the next-generation growth engine under "Project AP-G2016," and the Toray Group aims for further growth in the business field. Under the corporate philosophy of Contributing to society through the creation of new value with innovative ideas, technologies and products and corporate slogan of "Innovation by Chemistry," it is driven by the unwavering aspiration to become a global top company of advanced materials and take on the challenge of innovation (innovation and creation) in every corporate and business activity field.

■Orient EuroPharma Co.,Ltd.
Head office: 7F., No. 368, Sec. 1 Fu Hsing S. Rd.,Taipei 106, Taiwan, R.O.C.
Chairman & CEO: Peter Tsai
Website: http://www.oep.com.tw/en-global

Orient EuroPharma Co., Ltd (OEP), a comprehensive global pharmaceutical company, was founded in 1982 under the core values of "Integrity, Solidarity and Innovation." It is officially listed in the Gre-Tai Securities market in 2003. OEP has 9 subsidiaries in Asia Pacific with more than 760 employees worldwide, of which some 40% are overseas employees. OEP’s products include pharmaceuticals, cancer drugs, cosmeceutical, infant & adult nutrition and healthcare products. In addition, OEP owns strong sales and marketing network in Asia-Pacific. OEP is committed to NCE (new chemical entity) development of new drugs, and several products in the pipeline have entered phase III clinical trial. Besides, In 2008, OEP established a subsidiary OrientPHARMA Co., Ltd (OP) for developing and manufacturing new drugs, especially in the drugs corresponding to a new drug application 505(b)(2) and generics . In 2013, OP Nano Co., Ltd (ON) was founded for developing cancer drugs, and a new injection plant’s construction began in 2014.

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