A marketing authorisation application for SOT-375 (Eligard in the US) has been submitted by Sosei Co Ltd to the Japanese ministry of health, labour and welfare (MHLW) requesting approval for marketing in Japan.

SOT-375 is an injectable formulation of leuprolide acetate designed to deliver 3.75 mg of the drug substance at a controlled rate over 30 days. This formulation is administered subcutaneously where it forms a biodegradable slow-release implant. Sosei is developing SOT-375 and has successfully finished a series of clinical studies in Japan needed to complete the marketing authorisation dossier.

In January 2003 Sosei in-licensed the exclusive rights to develop and commercialise SOT-375 in Japan from US based QLT, Inc (formerly Atrix Laboratories, Inc). In the US, the Eligard products contain various dosages of leuprolide acetate which have been approved by the FDA. They are currently marketed for the treatment of prostate cancer by QLT, Inc's licensee, Sanofi-Aventis. Various dosages of Eligard are also marketed in Germany, Australia, Canada and some Latin American countries as well as in the US.

Sosei has a collaborative strategy agreement with Nippon Organon K.K. to co-promote the product in Japan.

Commenting on this significant event, Sosei's CEO Shinichi Tamura stated:
"SOT-375 is the first product in our pipeline to reach the submission stage and is a key milestone in Sosei's development as a company. I believe that our product will strongly benefit patients in Japan and will be a worthwhile alternative to existing treatments."