Atrix Laboratories, Inc. announced that Atrix's Japanese licensee, Sosei Co. Ltd., has entered into a co-promotion agreement with Nippon Organon KK for Eligard products (leuprolide acetate for injectable suspension, known as SOT-375 in Japan) in Japan for the treatment of advanced prostate cancer.
"Sosei has already begun clinical trials for SOT-375 and we are pleased that they are actively moving forward in their marketing strategies for Eligard in Japan," said David R Bethune, Atrix's chairman and chief executive officer.
SOT-375 is a formulation of Eligard 7.5mg once-a-month prostate cancer product. Sanofi Synthelabo currently markets Eligard 7.5mg, 22.5mg, and 30mg products in the US. Eligard products have also received marketing authorization recently in several ex-US countries including Canada, Argentina, and Germany.
Nippon Organon KK was founded in 1960 as a joint venture with Sankyo Co., Ltd. Sales for 2002 were 21.3 billion Yen (approximately $200 million USD). Nippon Organon markets products in the field of urology, reproduction, depression, anesthesia, atherothrombosis and allergy for better quality of life in Japan.
Sosei Co. Ltd. is a leading Japanese biopharmaceutical company. In January 2003, Atrix and Sosei executed an exclusive agreement for the license to develop and commercialize Eligard in Japan. Sosei is responsible for any pre-clinical and clinical studies required for approval and will be responsible for submission of the necessary documents to obtain marketing authorization from the MHLW.