Intercept Announces New OCA Data in PBC and NASH to be Presented at EASL 2016

NEW YORK, March 30, 2016 (GLOBE NEWSWIRE) — Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat non-viral, progressive liver diseases, announced today that multiple abstracts evaluating obeticholic acid (OCA) in patients with primary biliary cirrhosis, recently renamed primary biliary cholangitis (PBC), and nonalcoholic steatohepatitis (NASH) will be presented at the International Liver Congress 2016, the 51st Annual Meeting of the European Association for the Study of the Liver (EASL), in Barcelona, Spain, from April 13-17, 2016.

Intercept will present eight abstracts at the Congress, including new analyses of the Phase 3 POISE trial in PBC and Phase 2 FLINT trial in NASH. Study designs for the Phase 3 REGENERATE Trial in NASH and Phase 2 CARE trial in biliary atresia will also be presented.

“It is exciting to see the new emphasis on non-viral liver disease at research forums like the International Liver Congress,” said David Shapiro, M.D., Intercept’s Chief Medical Officer & Executive Vice President, Development. “As we continue to prepare for potential U.S. and European approvals of OCA for patients with primary biliary cholangitis this year, cholestatic liver diseases like PBC and PSC are receiving more attention from researchers and clinicians. Additionally, new analyses of the FLINT trial continue to provide the hepatology community with important insights about NASH, a condition which is continuing to grow into a global public health issue in liver disease.”

In addition to the clinical study presentations and posters, two of Intercept’s collaborators will be giving oral presentations on the role of nuclear receptors in metabolism and cancer and the gut liver axis. Intercept will continue to explore this area with a recently announced research collaboration to evaluate the effects of OCA and other product candidates on the microbiome in a variety of non-viral liver diseases, beginning with NASH. 

Intercept will be exhibiting at booth #1200 throughout the meeting.  Presentations at the International Liver Congress include:

Oral Presentation

Saturday, April 16, 12:30 – 12:45, Hall 8.0-A1
“Predictors of Improvement in NAFLD Activity Score on Placebo: a Secondary Analysis of the FLINT Trial” (Abstract PS109)
Rohit Loomba, Arun J. Sanyal, Kris V. Kowdley, Norah Terrault, Naga Chalasani, Manal F. Abdelmalek, Arthur J. McCullough, Beatrice Ferguson, Lois Lee, Reshma Shringarpure, David Shapiro, Brent A. Neuschwander-Tetri

Basic Science Seminar – Gut-Liver Axis

Wednesday, April 13, 15:00 – 15:30, Hall 8.1-A1
“Tissue-Specific Actions of Nuclear Receptors in Metabolism and Cancer”
Antonio Moschetta, Marica C. Cariello

Thursday, April 14, 08:30 – 09:00, Hall 8.1-A1
“Identification of the Gut Vascular Barrier Linking the Gut with the Liver”
 Maria Rescigno, Ilaria Spadoni

Poster Presentations in PBC

Friday, April 15, 08:00 – 18:00, Hall 8.1
“Exposure-Response Relationship of Obeticholic Acid for Alkaline Phosphatase and Total Bilirubin in Patients with Primary Biliary Cirrhosis/Cholangitis” (Abstract FRI-394)
Jeffrey E. Edwards, Carl LaCerte, Leng Hong Pheng, Thomas Peyret, Nathalie H. Gosselin, J.F. Marier, and David Shapiro

Friday, April 15, 08:00 – 18:00, Hall 8.1
“Pruritus and Serum Autotaxin in Patients With Primary Biliary Cirrhosis Participating in the POISE Trial” (Abstract FRI-349)
Andreas E. Kremer, A. Ruth Bolier, Elizabeth Smoot Malecha, Ulrich Beuers, Mary Erickson, Roya Hooshmand-Rad, David Shapiro

Saturday, April 16, 08:00 – 18:00, Hall 8.1
“Improvement in Estimated Liver Transplant-Free Survival after 1 Year of Obeticholic Acid Treatment” (Abstract SAT-352)
Maren H. Harms, Willem J. Lammers, Tonya Marmon, Richard Pencek, Henk R. van Buuren, Bettina E. Hansen, David Shapiro

Saturday, April 16, 08:00 – 18:00, Hall 8.1
“Mitigation of Pruritus During Obeticholic Acid Treatment in Patients with Primary Biliary Cirrhosis: Strategies and Successes” (Abstract SAT-357)
Marlyn J. Mayo, Andreas Kremer, Ulrich Beuers, Tonya Marmon, Roya Hooshmand-Rad, Richard Pencek, David Shapiro

Poster Presentations in NASH

Thursday, April 14, 08:00 – 18:00, Hall 8.1
“REGENERATE: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Multicenter Study of Obeticholic Acid Therapy for Nonalcoholic Steatohepatitis” (Abstract THU-488)
Vlad Ratziu, Arun Sanyal, Leigh MacConell, Reshma Shringarpure, Tonya Marmon, David Shapiro, Zobair M. Younossi

Friday, April 15, 08:00 – 18:00, Hall 8.1
“Evaluation of Effects of Concomitant Medications for NASH and Associated Comorbidities on Histological Improvements with Obeticholic Acid” (Abstract FRI-310)
Kris V. Kowdley, Manal F. Abdelmalek, Arthur J. McCullough, Rohit Loomba, Bilal Hameed, Naga P. Chalasani, Brent A. Neuschwander-Tetri, Saswati Hazra, Jianfen Chen, Reshma Shringarpure, David Shapiro, Arun J. Sanyal

Poster Presentation in Biliary Atresia

Thursday, April 14, 08:00 – 18:00, Hall 8.1
“A Multicenter, Randomized, Open Label, Single- and Multiple-Dose, Dose Finding Study and Open-Label Extension to Assess the Effects of Obeticholic Acid in Pediatric Patients with Biliary Atresia” (Abstract THU-487)
Saul Karpen, Lise Eliot, Barbara Scholz, Maria M. Joshi, Michelle M. Merrigan, Cathi Sciacca, Tonya Marmon, Roya Hooshmand-Rad, Leigh MacConell, David Shapiro

Other Presentations

On Saturday, April 16, 2016 from 7:30 – 9:00, Intercept will host a showcase for the winning applications from the Global Practice to Policy Health Awards Program. Practice to Policy offers financial support to local and national projects in PBC that create valuable insights, evidence and learnings for the wider healthcare community across Europe, the United States and Canada.

Intercept will webcast an investor event on Saturday, April 16, 2016 starting at 19:00. During this webcast, management and thought leaders will provide an update on Intercept’s PBC commercial and medical initiatives.

A full list of sessions at the International Liver Congress, including symposia relating to OCA, is available on the EASL website.

About Intercept
Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat non-viral, progressive liver diseases. The Company’s lead product candidate, obeticholic acid (OCA), is an agonist of the farnesoid X receptor (FXR). OCA is being developed for a variety of chronic liver diseases, including primary biliary cirrhosis, recently renamed primary biliary cholangitis (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 liver fibrosis and granted OCA fast track designation for the treatment of patients with PBC. 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. Intercept’s pipeline of product candidates includes other novel bile acid analogs such as INT-767, which is in clinical development. 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 anticipated commercialization of OCA in PBC, the continued development of OCA and Intercept’s other product candidates, the development of OCA in NASH, including the timing and results of the REGENERATE trial, 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; 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, which may be affected by the reimbursement that our products receive from payors; 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 collaborators’ election to pursue research, development and commercialization activities; our ability to attract collaborators with development, regulatory and commercialization expertise; our need for and ability to obtain additional financing; our estimates regarding expenses, future revenues and capital requirements and the accuracy thereof; our use of cash and short term investments; 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, 2015 filed on February 29, 2016 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: Contact
For more information about Intercept Pharmaceuticals, please contact:

Mark Vignola

Christopher Frates