TOKYO, Japan and LONDON, England, February 28/PRNewswire-FirstCall/ -- Sosei Co. Ltd. (4565, Tokyo Stock Exchange MOTHERS index) announced today that a marketing authorisation application for SOT-375 (known as Eligard(R) in the US) has been submitted 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(R) 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(R) 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."

Mr. Paul Hasting, QLT Inc.'s CEO commented: "We are delighted with Sosei's progress in filing for approval of SOT-375 in Japan. Japan is the second largest pharmaceutical market in the world and clearly an important opportunity for us."

President and Representative Director of Nippon Organon, Mr. Hans M.A. van Eerd stated: "The filing of the marketing application for SOT-375 means we are looking forward to the early launch of this product. One of Nippon Organon's business strategies is to focus on the field of urology therapeutics. Avishot(R), one of our core products, is already used to treat the urological complications of benign prostatic hypertrophy and our experience with Avishot(R) will bring synergy benefits when we come to launch SOT-375."

This press release is provided in good-faith by Chiltern Magazine Services Ltd ("CMS") as a service to users. Whilst every care is taken in sourcing and preparing material included here, any error or incorrect content cannot form the basis for any legal action against the site-owner. Users are advised to check the accuracy of any statements before relying upon them. Likewise, any forward-looking statements made by the author of the press release should be treated as such.

For full details, please email keithw@cmsinfo.com