Intercept Announces New Data in PBC and NASH to be Presented at EASL 2015

NEW YORK, April 13, 2015 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT) (Intercept), a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat neglected chronic liver diseases, announced today that several abstracts evaluating obeticholic acid (OCA) in patients with primary biliary cirrhosis (PBC) and nonalcoholic steatohepatitis (NASH) will be presented at the International Liver Congress 2015, the 50th Annual Meeting of the European Association for the Study of the Liver (EASL), being held in Vienna, Austria, from April 22-26, 2015. Intercept also announced abstracts relating to PBC to be presented by the Global PBC Study Group and the UK-PBC Group at EASL.

OCA is a first-in-class farnesoid X receptor (FXR) agonist in clinical development for a range of chronic liver diseases. Intercept has initiated a rolling New Drug Application with the FDA for PBC, and expects to complete the NDA and MAA submissions in 2Q 2015. OCA was also recently granted breakthrough therapy designation by FDA for the treatment of NASH patients with liver fibrosis.

"We are excited to be presenting new OCA clinical data in both PBC and NASH patients," said Mark Pruzanski, M.D., Chief Executive Officer of Intercept. "Furthermore, the Global PBC Study Group and UK-PBC Group analyses will provide the hepatology community with additional scientific insights into potential treatment goals for patients with PBC. This is timely as we prepare for the anticipated launch of OCA in the U.S. and Europe next year."

Intercept will be exhibiting at booth #340 throughout EASL. A schedule highlighting key presentations and events follows:

OCA Poster Presentations

25 April 13:00 - 13:30

"Integrated Efficacy Summary for Obeticholic Acid in Subjects with Primary Biliary Cirrhosis" (Poster P1137, Room A-01)

Pietro Invernizzi; Rich Pencek; Tonya Marmon; Leigh MacConell; David Shapiro

"FXR Agonism with Obeticholic Acid May Attenuate Bone Mineral Density Decrease in Subjects with Primary Biliary Cirrhosis" (Poster P1155, Room A-10)

Albert Pares; Rich Pencek; Yvette Peters; Tonya Marmon; Leigh MacConell; Luciano Adorini; David Shapiro; Michael Trauner; David Jones

25 April 15:30 - 16:00

"A Phase 3B, Double Blind, Placebo Controlled Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cirrhosis at Elevated Risk of Progression to Liver Transplant or Death" (Poster P1321, Room C-01)

Keith Lindor; Bettina E. Hansen; Rich Pencek; Roya Hooshmand-Rad; Tonya Marmon; Leigh MacConell; David Shapiro; David Jones

OCA Late-Breaking Poster Presentation

25 April 15:30 - 16:00

"Obeticholic Acid for NASH: Benefits in a High Risk Subgroup and the Effects of Concomitant Statin Use" (Late-breaker Poster LP18, Room A-09)

Brent Neuschwander-Tetri; Arun Sanyal; Rohit Loomba; Naga Chalasani; Kris Kowdley; Manal Abdelmalek; Elizabeth Brunt; David Shapiro

Global PBC Study Group and UK-PBC Group Presentations

23 April 17:30 - 17:45

"The UK-PBC Risk Score: Derivation and Validation of a Risk Score to Predict Liver Events in the UK-PBC Research Cohort" (Oral Presentation Abstract O022, Strauss 1 room)

Marco Carbone; Stephen J. Sharp; Michael A. Heneghan; James M. Neuberger; Gideon M. Hirschfield; Andrew K. Burroughs; Douglas Thorburn; Andrew Bathgate; Mark Aldersley; Carolyn Adgey; Paul Trembling; Kate Williamson; Laura Jopson; Reyna T. Lim; Nick J. Wareham; Heather J. Cordell; Graeme J. Alexander; Jones E. Jones; Richard N. Sandford; George F. Mells; and UK-PBC Consortium

25 April 13:00 - 13:30

"Validation of Alkaline Phosphatase and Bilirubin Response Criteria as Biomarker for Transplant-Free Survival in Primary Biliary Cirrhosis in the World's Two Largest Cohorts" (Poster P1147, Room A-06)

Marco Carbone; Maren H. Harms; Keith Lindor; Gideon M. Hirschfield; Willem J. Lammers, Micheal Heneghan; Harry L.A. Janssen; James M. Neuberger; Douglas Thorburn; Albert Parès; Steven Sharp; Pietro Invernizzi; Nick Warheam; Annarosa Floreani; Andrew Bathgate; Christophe Corpechot; Mark Aldersley; Marlyn Mayo; Nick F. LaRusso; Frederik Nevens; Graeme J. Alexander; Kris W. Kowdley; Richard N. Sandford; Andrew L. Mason; David Jones; Henk R. van Buuren; George Mells; Bettina E. Hansen

A full list of sessions at EASL relating to OCA is available on the EASL website.

About Primary Biliary Cirrhosis

PBC is a rare liver disease that primarily results from autoimmune destruction of the bile ducts that transport bile acids out of the liver, resulting in cholestasis. It is primarily a disease of women, afflicting approximately one in 1,000 women over the age of 40. In Europe, the incidence of PBC is growing and the disease accounts for 50% of liver transplants for cholestatic disease and 6% of liver transplants overall.PBC is the second leading indication for liver transplant among women in the United States. Ursodiol is the only approved medication for PBC and studies have shown that up to 40% of PBC patients may have an inadequate response,thereby remaining at risk of adverse outcomes.

About Intercept

Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat neglected chronic liver diseases. The company's lead product candidate, obeticholic acid (OCA), is a first-in-class agonist of the farnesoid X receptor (FXR). OCA is being developed for a variety of chronic liver diseases, including primary biliary cirrhosis (PBC), nonalcoholic steatohepatitis (NASH), primary sclerosing cholangitis (PSC) and biliary atresia. The FDA has granted OCA breakthrough therapy designation for the treatment of NASH with fibrosis and granted OCA fast track designation for the treatment of patients with PBC who have an inadequate response to or are intolerant of ursodiol. OCA has also received orphan drug designation in both the United States and Europe for the treatment of PBC and PSC. Intercept owns worldwide rights to OCA outside of Japan, China and Korea, where it has out-licensed the product candidate to Sumitomo Dainippon Pharma. For more information about Intercept, please visit the Company's website at:

Safe Harbor Statements

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the clinical relevance of the Global PBC Study Group and/or the UK-PBC Group data and the applicability thereof to OCA in PBC, the potential relationship between ALP and bilirubin and adverse clinical outcomes, the clinical utility of the POISE trial selected endpoints and any potential consensus relating thereto, clinical, preclinical and regulatory developments for our product candidates, the anticipated timetable for our clinical, regulatory, development and commercialization activities, the anticipated results of our clinical and preclinical trials and other development activities and the timing thereof, and our strategic directives under the caption "About Intercept." These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of important risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the initiation, cost, timing, progress and results of our development activities, preclinical studies and clinical trials; the timing of and our ability to obtain and maintain regulatory approval of OCA, INT-767 and any other product candidates we may develop, particularly the possibility that regulatory authorities may require clinical outcomes data (and not just results based on achievement of a surrogate endpoint) as a condition to any marketing approval for OCA, and any related restrictions, limitations, and/or warnings in the label of any approved product candidates; our plans to research, develop and commercialize our product candidates; the election by our collaborators to pursue research, development and commercialization activities; our ability to attract collaborators with development, regulatory and commercialization expertise; our ability to obtain and maintain intellectual property protection for its product candidates; our ability to successfully commercialize our product candidates; the size and growth of the markets for our product candidates and our ability to serve those markets; the rate and degree of market acceptance of any future products; the success of competing drugs that are or become available; regulatory developments in the United States and other countries; the performance of third-party suppliers and manufacturers; our need for and ability to obtain additional financing; our estimates regarding expenses, future revenues and capital requirements and the accuracy thereof; our ability to retain key scientific or management personnel; and other factors discussed under the heading "Risk Factors" contained in our annual report on Form 10-K for the year ended December 31, 2014 filed on March 2, 2015 as well as any updates to these risk factors filed from time to time in our other filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Intercept undertakes no duty to update this information unless required by law.


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