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news.Sosei has submitted a marketing authorization application for its prostate cancer treatment, SOT-375, to the Japanese Ministry of Health, Labor and Welfare requesting approval for marketing in Japan.
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SOT-375, known as Eligard in the US, is an injectable formulation of leuprolide acetate designed to deliver 3.75mg of the drug substance at a controlled rate over 30 days. Sosei is developing SOT-375 and has successfully finished a series of clinical studies in Japan needed to complete the marketing authorization dossier.
“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,” said Sosei’s CEO, Shinichi Tamura. “I believe that our product will strongly benefit patients in Japan and will be a worthwhile alternative to existing treatments.”
In January 2003, Sosei in-licensed the exclusive rights to develop and commercialize SOT-375 in Japan from US-based QLT Inc (formerly Atrix Laboratories). 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’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 KK to co-promote the product in Japan.