Sosei Files Japan MAA for Prostate Cancer Drug SOT-375

QLT has announced that its partner Sosei has submitted a marketing authorization application for SOT-375, a drug developed for prostate cancer, 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 for the palliative treatment of prostate cancer and has successfully finished a series of clinical studies in Japan needed to complete the dossier.

Sosei in-licensed the exclusive rights to SOT-375 from its U.S.-based manufacturer, QLT USA. This agreement was signed in January 2003 and grants Sosei rights to develop and commercialize this product in Japan.