Intercept Pharmaceuticals

Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases. Intercept’s lead product, OCALIVA™ (obeticholic acid), was granted accelerated approval by U.S. Food and Drug Administration (FDA) in May of 2016 for the treatment of primary biliary cholangitis, previously known as primary biliary cirrhosis (PBC), in combination with ursodeoxycholic (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. Ocaliva is the first PBC therapy that targets the farnesoid X receptor (FXR), a key regulator of bile acid, inflammatory, fibrotic and metabolic pathways. For more information, please visit ocaliva.com. Obeticholic acid (OCA) is also being evaluated for potential indications across a variety of additional chronic liver diseases, including nonalcoholic steatohepatitis (NASH), primary sclerosing cholangitis (PSC), and biliary atresia. The FDA has granted OCA breakthrough therapy designation for the treatment of NASH with liver fibrosis. Intercept owns worldwide rights to OCA outside of Japan, China, and Korea, where it has out-licensed the product candidate to Sumitomo Dainippon Pharma. Founded in 2002 in New York, New York, Intercept now has operations in the United States, Europe, Canada, and Australia. OCALIVA is a trademark of Intercept Pharmaceuticals, Inc.