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Dainippon Sumitomo Pharma and Intercept Pharmaceuticals partner

Friday, April 1, 2011 11:47 AM

Japan-based Dainippon Sumitomo Pharma (DSP) and U.S.-based Intercept Pharmaceuticals announced an exclusive licensing agreement for the development and commercialization of Intercept's first-in-class FXR agonist obeticholic acid (OCA, also known as INT-747), according to FierceBiotech. DSP will advance OCA in Japan and China for the treatment of chronic liver diseases, initially focusing on primary biliary cirrhosis (PBC) and nonalcoholic steatohepatitis (NASH).

Under the terms of the licensing agreement, Intercept will receive an initial payment from DSP of $15 million and will be eligible to receive approximately $300 million in additional milestone payments associated with the successful development and commercialization of OCA.

"This agreement is an important milestone for our OCA program and provides additional confirmation of our drug's potential," said Mark Pruzanski, M.D., president and CEO of Intercept. "We are excited to be partnering in Asia with DSP, given its proven track record in the development and commercialization of drugs in the hepatology area. This collaboration with DSP will provide important development support as we advance OCA in parallel for PBC, NASH and possibly other indications."

Intercept is preparing for the initiation of a phase III PBC program in the U.S. and E.U.  Intercept has also begun enrolling patients in a large placebo-controlled trial of OCA in NASH in the U.S. under the company's cooperative research and development agreement with the National Institute of Diabetes and Digestive and Kidney Diseases.

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