Completion Of Phase I Clinical Trial Of Sancuso(R) In Japanese Volunteers

Main Category: Cancer / Oncology
Also Included In: Clinical Trials / Drug Trials
Article Date: 02 Nov 2009 - 4:00 PST

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Solasia Pharma K.K., a developer of Western oncology pharmaceuticals in-licensed for commercialization in Asian markets, announced 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).

Source
Solasia Pharma K.K.