and DONG-A Pharmaceuticals will manufacture, develop, and commercialize Access Pharmaceuticals' ProLindac
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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