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Intercept Pharmaceuticals Announces Positive Phase II Results for Obeticholic Acid (INT-747) as Monotherapy in Primary Biliary Cirrhosis
Date:3/31/2011

ipal investigator in the study, commented, "There is a real need for novel therapies in PBC.  The clinically meaningful results from this study are highly supportive of OCA's potential as an effective new drug. We know now that OCA is effective given both in addition to UDCA and, from this study, when given alone.  The reductions in AP levels were very substantial and occurred within a month.  The effects on IgM and inflammatory markers suggest that OCA may have disease modifying properties."

Intercept's Chief Medical Officer, David Shapiro, MD, commented, "This study involved 20 centers in 7 countries and has given us and the PBC thought leaders involved a better understanding of the potent mechanism of action of OCA.  With the international PBC network we have established, we are well positioned to conduct a Phase III program.  We are currently discussing requirements for approval with FDA and have received guidance from the EMA supportive of our proposed program."

Mark Pruzanski, MD, Intercept's Chief Executive Officer, added, "The remarkable results achieved with OCA treatment in this study, together with the previously announced positive Phase II results with our drug added to UDCA in refractory PBC patients and in diabetic patients with nonalcoholic fatty liver disease, supports OCA's potential as a novel hepatoprotective drug that may help preserve liver function in patients with a variety of chronic liver diseases."

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 announced positive Phase II results from randomized clinical trials in patients with primary biliary cirrhosis (PBC), the most common autoimmune liver disease, and in type 2 diabetics with nonalcoholic fatty liver disease.  These clinical data and OCA's mechanism
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SOURCE Intercept Pharmaceuticals, Inc.
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1. Dainippon Sumitomo Pharma and Intercept Pharmaceuticals Announce Agreement to Develop and Commercialize Obeticholic Acid (INT-747) for Chronic Liver Disease
2. Initiation of FLINT Announced by NIDDK: Study of Intercept Pharmaceuticals Obeticholic Acid (INT-747) in NASH
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