Nippon Shinyaku Co., Ltd. and Janssen Pharmaceutical K.K. to Jointly Develop New Oral Immediately-Release Painkiller

02-24-2005: Nippon Shinyaku Co., Ltd., Janssen Pharmaceutical K.K. and Grunenthal GmbH have concluded a co-development agreement to jointly develop and commercialize in Japan an oral painkiller, Tramadol Hydrochloride Immediate-Release Formulation as of February 14, 2005.

Tramadol hydrochloride, a compound discovered by Germany-based Grunenthal, came to the German market in 1981 as an oral immediate-release formulation. Since then, various formulations containing tramadol hydrochloride have been launched in more than 100 countries worldwide.

Nippon Shinyaku concluded a license agreement for tramadol hydrochloride immediate-release formulation in 1996 and has proceeded with its clinical development for cancer pain since then. Under this tripartite agreement, Janssen Pharmaceutical will develop this formulation for treating non-malignant pain. Nippon Shinyaku and Janssen Pharmaceutical plan to develop its indication separately, but submit for its NDA application simultaneously and distribute it under different trademarks.