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news.Access Pharmaceuticals and Jiangsu Aosaikang Pharmaceutical have signed a definitive licensing agreement under which ASK will manufacture, develop and commercialize Access's product ProLindac for the Greater China Region which includes the People's Republic of China, the Hong Kong Special Administrative Region, the Macau Special Administrative Region and Taiwan.
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Under the terms of the agreement Jiangsu Aosaikang Pharmaceutical (ASK) will pay Access an upfront fee and subsequent milestone payments along with a double digit royalty upon commercialization of ProLindac.
In addition, in co-operation with Access, ASK has committed to fund and execute two Phase II studies for ProLindac in colorectal cancer and one other indication to be determined by the parties. These major Phase II studies would cost up to $20 million if conducted in the US or Europe.
ASK has also committed to become a second source for the manufacturing of ProLindac. ASK will be responsible for obtaining the necessary regulatory approvals for ProLindac and commercializing the product in the Greater China Region.
ProLindac is Access’s novel prodrug currently in Phase II clinical studies which has been shown to be active in a variety of solid tumors in both preclinical models and in human trials.
Jeffrey Davis, president and CEO of Access, said: “With the recently announced positive results from the ongoing clinical study plus this commitment from ASK, we believe we are well positioned to quickly advance the development of ProLindac.”