NEW YORK, June 22, 2017 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced that Ocaliva ® (obeticholic acid) has been granted the 2017 Premio Galeno Italia (Prix Galien) Chemical Synthesis Drug Award. The Premio Galeno Italia is one of the most recognized honors in the Italian life sciences industry, and this award reflects the innovation Ocaliva represents as a novel treatment for primary biliary cholangitis (PBC). PBC is a rare autoimmune liver disease that, if left untreated, can progress to hepatic fibrosis, cirrhosis, liver failure, and death unless a patient receives a liver transplant. For almost 20 years ursodeoxycholic acid (UDCA) was the only approved treatment for PBC; however, a substantial proportion of patients do not adequately respond to UDCA or are intolerant to UDCA. Ocaliva, which is a farnesoid X receptor (FXR) agonist, is indicated to address these patients with high unmet need. The Scientific Board that awarded the prize stated that Ocaliva is "very innovative both from the point of view of patients and therapeutically" and noted that the mechanism of action is both different and complementary to UDCA, allowing Ocaliva to more directly, and effectively, modulate the molecular and cellular mechanisms which underlie the disease. The Ocaliva story began in Italy. Professor Roberto Pellicciari and a team of researchers at the University of Perugia pioneered research in the field of bile acid chemistry in the 1990s, which led to the discovery of obeticholic acid. Professor Pellicciari helped found Intercept in 2002 to advance obeticholic acid and discover other molecules under an ongoing collaboration that has underpinned the innovation recognized today. In May 2016, the U.S. Food and Drug Administration granted accelerated approval to Ocaliva for the treatment of PBC in combination with UDCA in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. This was followed in December 2016 by conditional marketing authorization in the European Union and conditional approval in Canada in May 2017 for the same indication.