Access Pharmaceuticals, Inc and JCOM Ltd, an affiliate of DONG-A Pharmaceuticals, the premier pharmaceutical company in the Republic of Korea, signed a definitive licensing agreement under which JCOM and DONG-A will manufacture, develop and commercialize Access' proprietary products ProLindac and MuGard for the Republic of Korea.
ProLindac is Access' novel DACH platinum prodrug currently in phase-2 clinical studies which has been shown to be active in a wide variety of solid tumours in both preclinical models and in human trials. MuGard is used for the management of oral mucositis, a debilitating side effect of many anticancer chemotherapy and radiation treatments, 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-2 combination study for ProLindac in an indication to be determined by the Parties. This controlled phase-2 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.
"We are very pleased to have JCOM and Dong-A as partners for ProLindac and MuGard," said Jeffrey B Davis, Access' president & CEO. "We are excited about their commitment to rapidly start a phase-2 study with ProLindac. This is the third major Phase 2 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." Davis continued, "We are also extremely excited about having one of the largest pharma companies in Korea promoting our MuGard product."
ProLindac is a novel DACH platinum prodrug which has been shown to be active in a wide variety of solid tumors in both preclinical models and in human trials.
MuGard is a ready-to-use mucoadhesive oral wound rinse. The mucoadhesive formulation forms a protective coating over the oral mucosa when washed around the mouth.
Access Pharma is an emerging biopharmaceutical company that develops and commercializes propriety products for the treatment and supportive care of cancer patients.