Sancuso Clinical Trial Application Filed in China

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Mon Jun 1, 2009 1:11pm EDT

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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