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Intercept Announces Data to be Presented at the 2014 AASLD Annual Meeting

NEW YORK, Oct. 8, 2014 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat chronic liver and intestinal diseases, today announced upcoming presentations of data at the upcoming American Academy for the Study of Liver Diseases (AASLD) Annual Meeting (the Liver Meeting®), being held in Boston, Massachusetts from November 7-11, 2014.

Obeticholic acid (OCA), Intercept's lead product candidate, is a bile acid analog and first-in-class agonist of the farnesoid X receptor (FXR) in development for primary biliary cirrhosis (PBC), nonalcoholic steatohepatitis (NASH), primary sclerosing cholangitis (PSC) and other chronic liver and intestinal diseases. Intercept is also developing the preclinical product candidates INT-777 (an agonist of TGR5, a bile acid receptor) and INT-767 (a dual FXR/TGR5 agonist).

"This is an exciting time for the hepatology community and liver disease patients, with new discoveries being made in multiple areas of unmet need," said Mark Pruzanski, M.D., Chief Executive Officer. "We are pleased that several key abstracts from Intercept's Phase 3 program for OCA in PBC will be presented at AASLD. With respect to the NIDDK-sponsored FLINT trial of OCA in NASH, we have learned that the NASH CRN has decided to focus on finalizing the manuscript intended for near term publication in lieu of presentation at AASLD. We are reaffirming the previously reported top-line results based on a revised draft manuscript that our partners at NIDDK have provided us. We believe that peer reviewed publication of the FLINT data will mark another important milestone supportive of OCA's potential as a novel therapy for patients with NASH and associated liver fibrosis. In the meantime, we continue preparing for the initiation of our Phase 3 NASH program in the first half of 2015. We would like to thank all of our collaborators who have dedicated themselves to the search for critically needed new drugs that may benefit patients suffering from PBC, NASH and other liver diseases."

Intercept will be exhibiting at booth #313 throughout the meeting. A schedule highlighting key presentations at AASLD follows:

OCA Poster Presentations

Saturday, November 8, 2014 from 2:00 PM - 7:30 PM in the Poster Hall

"An International Phase 3 Study of the FXR Agonist Obeticholic Acid in PBC Patients: Effects on Markers of Cholestasis Associated with Clinical Outcomes and Hepatocellular Damage" (Poster 295)

Frederik Nevens; Pietro Andreone; Giuseppe Mazzella; Simone I. Strasser; Christopher L. Bowlus; Pietro Invernizzi; Joost Drenth; Paul J. Pockros; Jaroslaw Regula; Michael Trauner ; Annarosa Floreani; Simon Hohenester; Velimir A. Luketic; Mitchell L. Shiffman; Karel J. van Erpecum; Victor Vargas; Catherine Vincent; Bettina E. Hansen; Roya Hooshmand-Rad; Shawn Sheeron; David Shapiro

"Obeticholic Acid in PBC Patients: The Utility of Titration Based on Therapeutic Response and Tolerability" (Poster 305)

Christopher L. Bowlus; Paul J. Pockros; Joost Drenth; Annarosa Floreani; Catherine Vincent; Velimir A. Luketic; Karel J. van Erpecum; Victor Vargas; Mitchell L. Shiffman; Frederik Nevens; Richard Pencek; Roya Hooshmand-Rad; David Shapiro

"Efficacy of Obeticholic Acid In Primary Biliary Cirrhosis as Assessed by Response Criteria Associated With Clinical Outcome: A POISE Analysis" (Poster 309)

Velimir A. Luketic; Pietro Invernizzi; Michael Trauner ; Jaroslaw Regula; Giuseppe Mazzella; Simone I. Strasser; Annarosa Floreani; Simon Hohenester; Karel J. van Erpecum; Paul J. Pockros; Bettina E. Hansen; Henk R. van Buuren; Frederik Nevens; Richard Pencek; Roya Hooshmand-Rad; David Shapiro

"FXR Agonist Obeticholic Acid: Pruritus, A Common Side Effect Ameliorated by Dose Titration" (Poster 310)

Ulrich Beuers; David E. Jones; Marlyn J. Mayo ; Pietro Andreone; Giuseppe Mazzella; Simon Hohenester; Annarosa Floreani; Simone I. Strasser; Christopher L. Bowlus; Pietro Invernizzi; Joost Drenth; Paul J. Pockros; Jaroslaw Regula; Velimir A. Luketic; Karel J. van Erpecum; Victor Vargas; Catherine Vincent; Roya Hooshmand-Rad; Shawn Sheeron; David Shapiro

"The FXR Agonist Obeticholic Acid (OCA) Improves Liver Biochemistry Parameters Correlated With Clinical Benefit Across a Range of Patient Characteristics" (Poster 318)

Pietro Andreone; Giuseppe Mazzella; Simone I. Strasser; Christopher L. Bowlus; Pietro Invernizzi; Joost Drenth; Paul J. Pockros; Jaroslaw Regula; Michael Trauner; Annarosa Floreani; Simon Hohenester; Velimir A. Luketic; Mitchell L. Shiffman; Karel J. van Erpecum; Victor Vargas; Catherine Vincent; Bettina E. Hansen; Frederik Nevens; Richard Pencek; Roya Hooshmand-Rad; Shawn Sheeron; David Shapiro

"FXR Agonist Obeticholic Acid: Sustained Improvement in Markers of Cholestasis and Long-Term Safety in Patients with Primary Biliary Cirrhosis through 4 Years" (Poster 319)

Kris V. Kowdley; Richard Pencek; Tonya Marmon; David Shapiro; Roya Hooshmand-Rad

Other Poster Presentations

"Downregulation of pro-fibrotic and pro-inflammatory genes in liver sinusoidal endothelial cells following activation of the bile acid receptors FXR and TGR5" (Poster 428)

Rachel McMahan, Cara Porsche, Michael Edwards, Luciano Adorini, Moshe Levi, Hugo R. Rosen

"Treatment with the FXR-TGR5 dual agonist INT-767 decreases NAFLD-NASH in mice fed a Western diet" (Poster 1111)

Xiaoxin Wang, Yuhuan Luo, Cherelle Parker, Rachel McMahan, Hugo R. Rosen, David J. Orlicky, Luciano Adorini, Moshe Levi

"Modulation of bile acid receptor TGR5: novel therapy for heart failure" (Poster 1287)

Moreshwar S. Desai, Zainuer Shabier, Jorge Coss-Bu, Sundararajah Thevananther, David D. Moore, Saul J. Karpen, Daniel J. Penny

Other Presentations

Intercept will webcast an investor event on Monday, November 10, 2014 starting at 6:30 pm ET. During this webcast, management and key opinion leaders will review Intercept's development programs, including PBC and NASH.

A full list of sessions at AASLD, including symposia, relating to OCA is available on the AASLD website.

About Intercept

Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat orphan and more prevalent chronic liver and intestinal diseases utilizing its expertise in bile acid chemistry. The company's lead product candidate, obeticholic acid (OCA), is a bile acid analog and 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), alcoholic hepatitis and primary sclerosing cholangitis (PSC). OCA has received Fast Track Designation in the United States and orphan drug designation in both the United States and Europe for the treatment of PBC and PSC. Several large, randomized, controlled studies of OCA in the treatment of chronic liver disease have been completed. These include Intercept's Phase 3 POISE trial for the treatment of patients with PBC and the FLINT trial for the treatment of patients with NASH. FLINT was sponsored by the U.S. National Institute of Diabetes and Digestive and Kidney Diseases, or NIDDK, a part of the National Institutes of Health. Top-line results from the FLINT trial based on a draft manuscript prepared by the NASH Clinical Research Network (NASH CRN) were provided in Intercept's quarterly report on Form 10-Q on August 11, 2014. 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: www.interceptpharma.com.

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, preclinical and regulatory developments for our product candidates, the anticipated results of our clinical and preclinical trials and other development activities and the timing thereof, our potential development and regulatory milestones and the timeframes under which we anticipate such milestones may be achieved, including the anticipated timing for the initiation of our Phase 3 NASH program, the clinical utility of our selected endpoint and any potential consensus relating thereto 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, INT-777 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, 2013 filed on March 14, 2014 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.

CONTACT: For more information about Intercept Pharmaceuticals, please contact: Intercept Pharmaceuticals: Barbara Duncan or Senthil Sundaram +1-646-747-1000 investors@interceptpharma.com Media inquiries: Chantal Beaudry or Christopher Frates Lazar Partners + 1-212-867-1762 Intercept@lazarpartners.com

Source:Intercept Pharmaceuticals, Inc.