JCOM and DONG-A Pharmaceuticals will manufacture, develop, and commercialize Access Pharmaceuticals' ProLindac and MuGard for the Republic of Korea. ProLindac is in Phase II studies in ovarian cancer. MuGard is approved in the U.S. and EU for the management of oral mucositis, a side effect of chemotherapy and radiation treatments.
According to the license arrangement, JCOM will pay an up-front fee, milestones, and a double-digit royalty for both products. Dong-A will be responsible for obtaining the necessary regulatory approvals for ProLindac and MuGard and commercializing the products in the Republic of Korea.
Additionally, JCOM will fund and execute a Phase II combination study of ProLindac in an indication to be determined along with Access. Such an investigation would reportedly cost up to $10 million if conducted in the U.S. or Europe.
In June 2008, Jiangsu Aosaikang Pharmaceutical obtained a license for ProLindac in the Greater China Region. Mugard, which was sanctioned by the FDA last year, will be marketed by Milestone Bioscience in the U.S. and Europe under a $10 million agreement with Access. The product will be marketed by SpePharm in the EU, Switzerland, Norway, and Iceland.
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