Intercept Pharmaceuticals Announces Initiation of Phase 2 NASH Trial of OCA in Japan

NEW YORK, Jan. 7, 2013 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT) (Intercept), a clinical stage biopharmaceutical company focused on the development and commercialization of novel bile acid therapeutics to treat chronic liver diseases, today announced that its partner Dainippon Sumitomo Pharma (DSP) has initiated a phase 2 clinical trial of obeticholic acid (OCA) in adult nonalcoholic steatohepatitis (NASH) patients in Japan.

The trial is studying the efficacy and safety of a once daily dose of OCA, with the goal of randomizing 200 NASH patients to receiving OCA or placebo. The primary endpoint will be evaluated by histological improvement. DSP expects to complete the trial in the first half of 2016.

"We have previously shown that OCA can improve both liver enzyme levels and insulin sensitivity in diabetic patients with nonalcoholic fatty liver disease, so are pleased that we now have two randomized trials ongoing with OCA in NASH," commented Mark Pruzanski, MD, Intercept's Chief Executive Officer. "We recently announced that the NIDDK completed enrollment of FLINT, the U.S.-based phase 2b NASH trial from which we expect results in late 2014, and we are excited to see that DSP has moved quickly to start this trial after completing phase 1 studies with OCA in Japan."

About NASH

NASH is a liver disease in which fat accumulates in the liver, inducing chronic inflammation and progressive fibrosis (scarring) that can lead to cirrhosis and liver failure. Studies have shown that at least 15% of NASH patients will develop liver cirrhosis over a ten to 15 year period. In the United States, the most recent epidemiological analysis concluded that more than 12% of the general population has NASH, while approximately 2.7%, or more than eight million patients, have advanced liver fibrosis or cirrhosis due to the disease. In the past decade, the proportion of liver transplants attributed to NASH increased from 1% to 10%, establishing NASH as the third leading indication for liver transplant in the United States. The prevalence of NASH in Europe and Japan is similar, and the disease has also become common in developing countries such as India and China. There are currently no drugs approved for the treatment of NASH.

About Intercept

Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat orphan and more prevalent liver 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 initially being developed for the second line treatment of primary biliary cirrhosis (PBC) in patients with an inadequate response to, or who are unable to tolerate, ursodiol, the only approved therapy for this indication. OCA has received orphan drug designation in both the United States and Europe for the treatment of PBC. OCA is also being tested in a phase 2b NASH trial, called the FLINT trial, that is testing a 25 mg single daily dose of OCA versus placebo in 280 patients with NASH. Intercept is sponsoring the FLINT trial in collaboration with the U.S. National Institute of Diabetes and Digestive and Kidney Diseases which oversees a clinical research network of eight leading NASH centers in the United States. Intercept owns worldwide rights to OCA outside of Japan and China, where it has out-licensed the product candidate to DSP. For more information about Intercept, please visit the Company's website at:

Safe Harbor Statement

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the anticipated timeframe in which results from the NASH trials conducted by DSP and the NIDDK will be available, the number of patients anticipated to be enrolled and the number of cohorts to be utilized in the trial by DSP, the utility of the endpoints in the trial conducted by DSP, DSP's continuation of the trial to completion, and Intercept's 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 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 success and timing of Intercept's preclinical studies and clinical trials; Intercept's ability to obtain and maintain regulatory approval of OCA and any other product candidates it may develop, and the labeling under any approval it may obtain; regulatory developments in the United States and other countries; the performance of third-party manufacturers; Intercept's plans to develop and commercialize its product candidates; Intercept's ability to obtain and maintain intellectual property protection for its product candidates; the successful development of Intercept's sales and marketing capabilities; the potential markets for Intercept's product candidates and its 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; the loss of key scientific or management personnel; Intercept's ability to obtain additional financing; the accuracy of Intercept's estimates regarding expenses, future revenues and capital requirements; and other factors discussed under the heading "Risk Factors" contained in Intercept's quarterly report on Form 10-Q filed with the Securities and Exchange Commission on November 26, 2012, as well as any updates to these risk factors filed from time to time in Intercept's 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.

For more information about Intercept, please contact Mark Pruzanski, M.D., or Barbara Duncan, both of Intercept Pharmaceuticals, at 1-646-747-1000.

CONTACT: Mark Pruzanski, M.D. Barbara Duncan Intercept Pharmaceuticals 1-646-747-1000Source:Intercept Pharmaceuticals, Inc.