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Dainippon Sumitomo Pharma and Intercept Pharmaceuticals Announce Agreement to Develop and Commercialize Obeticholic Acid (INT-747) for Chronic Liver Disease
Date:3/30/2011

liver patients in Japan. We strongly believe that OCA has the potential to significantly add to the treatment options DSP can make available to these patients and are looking forward to working with Intercept to bring OCA to the market as an important new therapy for PBC and the first drug approved for NASH."

"This agreement is an important milestone for our OCA program and provides additional confirmation of our drug's potential," said Mark Pruzanski, MD, 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."

About Obeticholic Acid (OCA or INT-747)

OCA is a potent, first-in-class farnesoid X receptor (FXR) agonist derived from the primary human bile acid chenodeoxycholic acid, the natural endogenous FXR agonist.  Intercept has previously announced positive Phase II results from randomized clinical trials in patients with primary biliary cirrhosis (PBC) and in type 2 diabetics with nonalcoholic fatty liver disease.  The clinical data and mechanism of action support OCA's potential as a novel, hepatoprotective agent in a broad range of chronic liver diseases.  

About Primary Biliary Cirrhosis (PBC)

PBC is the most common autoimmune chronic liver disease that primarily afflicts women over the age of 40. PBC causes substantial loss of intrahepatic bile ducts, resulting in impaired bile flow (cholestasis) and progressive fibrosis that leads eventually to cirrhosis. It is estimated that there are approximately 50,000 PBC patients in Japan and more than 400,000 in China.  Given inadequate treatment options, up to 50% of such patients worldwide continue to be at significant risk of progression to liver transplant or death.


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SOURCE Intercept Pharmaceuticals, Inc.
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