| May 14,2003 | ||||||||||||
Toray and Nippon Shinyaku to Jointly Develop Oral Controlled-Release Painkiller |
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| Toray Industries, Inc. and Nippon Shinyaku Co., Ltd. have
agreed to jointly develop and commercialize in Japan a new oral controlled-release
painkiller, Tramadol Hydrochloride Controlled Release (THCR; Toray development
codename TRK-091), the active constituent of which is tramadol hydrochloride. Tramadol hydrochloride is positioned as a painkiller (moderate analgesic) that fills the niche between powerful analgesics conventionally used to treat symptoms such as cancer pain, and non-steroidal anti-inflammatory drugs (weak analgesics) used to treat mild symptoms such as headache and joint pain. Tramadol hydrochloride, a compound discovered by Germany-based Grunenthal, appeared on the German market in 1977 as an oral immediate-release formulation (to be taken three or four times per day). Since then, various formulations containing tramadol hydrochloride have been launched in more than 100 countries worldwide. Nippon Shinyaku has proceeded with the clinical development in Japan of oral immediate-release formulations containing tramadol hydrochloride, which was introduced from Grunenthal, to relieve post-operative and cancer pain. Meanwhile, Toray has been licensed by U.S.-based Purdue Pharma to develop and sell Tramadol Hydrochloride Controlled Release (THCR - to be taken once per day) in Japan. Effective over a long period of time, THCR was developed using Purdue Pharmafs proprietary pharmaceutical manufacturing technology. A clinical trial of the drug has been conducted for treating chronic pain in the field of orthopedics. Nippon Shinyaku and Toray have conducted more or less concurrently the clinical development of different types of formulations containing tramadol hydrochloride. However, in the belief that by combining their development and sales capabilities they would be able to achieve much greater efficiency in the development and commercialization of THCR (TRK-091), the two companies have concluded a co-development agreement. Nippon Shinyaku and Toray plan to proceed with the commercialization of moderate analgesics, which constitute a new concept in the domestic fields of orthopedics and cancer pain management. Following this alliance, Toray intends to apply in the near future for approval of controlled-release formulations by utilizing Japanese medical trial data related to immediate-release formulations in the possession of Nippon Shinyaku. In addition, Nippon Shinyaku expects to be able to offer a line-up comprising both immediate- and controlled-release formulations, and to expand its painkiller business accordingly. At present, oral immediate-release formulations containing tramadol hydrochloride are widely used in Europe and the U.S. for treatment of chronic pain (lumbago, ostheoarthritis, etc.) in the field of orthopedics. In Japan, however, use of non-steroidal anti-inflammatory drugs is widespread, but such drugs in many cases fail to provide sufficient analgesic effects. It has also been reported that side-effects such as gastro-intestinal problems (bleeding, ulcers, etc.) and renal impairment have been observed with their long-term administration. There is currently a need for new pharmaceutical treatments in this field, in addition to which there is an increasing trend in Japanese medical practice to emphasize patients'quality of life (QOL). It is expected that the new controlled-release pharmaceutical, which can be used safely over a long period of time, will meet this need. Based on its policy of strategic growth in the life science field, Toray is focusing its efforts on research and development of new drugs that will enable the pharmaceutical and medical business to become one of Toray's core businesses in the 21st century. THCR (TRK-091), following TRK-820 which is being developed as an anti-pruritis for hemodialysis patients, is expected to reach the stage of commercialization in the near future. |
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