Completion of Phase I Clinical Trial of Sancuso® in Japanese Volunteers
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Fri, 30 Oct 2009 15:22:03 GMT |
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Solasia Pharma K.K.
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TOKYO - (Business Wire) Solasia Pharma K.K. (http://www.solasia.co.jp), a developer of Western oncology pharmaceuticals in-licensed for commercialization in Asian markets, announced today the completion of a Phase I clinical trial for SP-01 (extended release transdermal granisetron patch; brand name: Sancuso®) in Japanese volunteers. Sancuso is the first and only commercialized extended release granisetron transdermal product. Sancuso was approved for the prevention of chemotherapy-induced nausea and vomiting and launched in the U.S. in 2008. In Japan, granisetron injections and tablets have strong market acceptance with over 50% share of the anti-emetic market. Solasia also announced a U.S. patent for Sancuso was granted on October 27, 2009 to ProStrakan Group plc who developed and own the worldwide rights to Sancuso. The patent relates to a transdermal patch containing granisetron. “We are very pleased that Prostrakan has obtained the grant of the U.S. patent for Sancuso. This follows patent grants in the EU in 2007 and Japan in 2008, and reaffirms our confidence in the strength of the IP relative to other transdermal granisetron formulations including all such products currently in clinical development in Japan,” stated Solasia president Steve Engen. About Sancuso Sancuso is an extended release 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 for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately and/or highly emetogenic chemotherapy for up to 5 consecutive days. 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. (Tokyo, Japan) 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. In May 2008, Solasia acquired Asia rights to Sancuso (granisetron transdermal patch) from Strakan International. To date, the company has raised approximately $16 million in Series A financing. Solasia Pharma K.K. Takashi Ono, +81-(0)3-6721-8332 VP, Corporate Development tono@solasia.co.jp
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