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news.Access Pharmaceuticals, a biopharmaceutical company, and Jcom, an affiliate of Dong-A Pharmaceuticals, have signed a definitive licensing agreement under which Jcom and Dong-A will manufacture, develop and commercialize Access's products ProLindac and MuGard for the Republic of Korea.
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ProLindac is Access’s novel DACH platinum prodrug currently in Phase II clinical studies which has been shown to be active in a wide variety of solid tumors in both preclinical models and in human trials. MuGard is used for the management of oral mucositis, and has already received marketing allowance from US and European regulatory authorities.
Under the terms of the agreement Jcom will pay Access an upfront fee and subsequent milestone payments along with a double digit royalty upon commercialization of ProLindac and MuGard.
In addition, in co-operation with Access, Jcom has committed to fund and execute a Phase II combination study for ProLindac in an indication to be determined by the parties. This controlled Phase II combination study would cost up to $10 million if conducted in the US or Europe. Dong-A will be responsible for obtaining the necessary regulatory approvals for ProLindac and MuGard and commercializing the products in the Republic of Korea.
Jeffrey Davis, president and CEO of Access, said: We are very pleased to have Jcom and Dong-A as partners for ProLindac and MuGard. We are excited about their commitment to rapidly start a Phase II study with ProLindac. This is the third major Phase II study to be funded by our external partners for ProLindac and will allow us to build a robust data package in a number of potential indications far beyond what we could generate on our own.