Sancuso Clinical Trial Application Filed in China
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TOKYO--(Business Wire)-- Solasia Pharma K.K. (http://www.solasia.co.jp/en/index.html), a developer of Western oncology pharmaceuticals in-licensed for commercialization in Asian markets, announced today the filing of clinical trial application (CTA) of SP-01 (long-acting transdermal granisetron patch; brand name: Sancuso) to the China State Food and Drug Administration (SFDA). This represents the first regulatory-related filing in China made by Solasia. Upon SFDA approval of the application expected in the 1st quarter of 2010, Solasia will initiate Sancuso clinical trials in China through Excel PharmaStudies Inc. (http://www.excel-china.com), China`s largest Clinical Research Organization (CRO). Sancuso is the first and only commercialized long-acting granisetron transdermal product. By releasing the anti-emetic agent granisetron over a 5-day period, Sancuso reduces the need for daily dosing of injectable and oral agents. In China, Sancuso is expected to be well accepted by physicians and nurses seeking a more convenient method to prevent the debilitating effects of nausea and vomiting in patients receiving chemotherapy. As a single application provides protection over 5 days, Sancuso is expected to help reduce the duration of hospital stays of cancer patients currently receiving short-acting anti-emetic agents. About Sancuso: Sancuso is a long-acting transdermal system, delivering the anti-emetic, granisetron, steadily into the patient`s bloodstream over seven days without the need for injections or swallowing pills. Granisetron is a 5-HT3 receptor antagonist with well-established efficacy against chemotherapy-induced nausea and vomiting (CINV). Sancuso was approved by the U.S. Food & Drug Administration (FDA) on September 12, 2008. Prostrakan launched Sancuso in the U.S. in the fourth quarter of 2008. Patents protecting Sancuso have been granted in the EU (2007) and Japan (2008). About Solasia: Solasia Pharma K.K. is a privately owned specialty pharmaceutical company based in Tokyo, Japan. Solasia was formed in November 2006 by MPM Capital and Itochu Corporation to address unmet needs for important new Western oncology therapies throughout Asia. Our mission is to expedite patient access to unique oncology therapies through aggressive development and specialized commercialization throughout Japan, China and other Asian countries. Solasia Pharma K.K. Koji Shinozaki, +81-(0)3-6721-8332 VP, Corporate Development email: kshinozaki@solasia.co.jp Copyright Business Wire 2009
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