Intercept Pharmaceuticals Announces Completion of Enrollment in Phase 3 Primary Biliary Cirrhosis POISE Trial

Intercept Pharmaceuticals Announces Completion of Enrollment in Phase 3
Primary Biliary Cirrhosis POISE Trial

NEW YORK, Dec. 19, 2012 (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 it has completed enrollment
in POISE, its pivotal Phase 3 clinical trial of obeticholic acid (OCA) in
primary biliary cirrhosis (PBC). Results from the 12-month double-blind
portion of POISE are anticipated to be available in the second quarter of 2014
and, if successful, will be used to seek regulatory approval of OCA, a
first-in-class FXR agonist, as a second line treatment in PBC. By enrolling
218 patients at 59 centers in 13 countries, Intercept exceeded its targeted
number of patients and completed enrollment in POISE faster than originally

"We are delighted that POISE is fully enrolled ahead of schedule and believe
this reflects the enthusiasm of both the investigators and patients for a new
treatment option," commented David Shapiro, MD, Intercept's Chief Medical

About Primary Biliary Cirrhosis and the POISE Trial

PBC is an autoimmune liver disease that may progress to cirrhosis and liver
failure, and it is currently the fifth leading indication for liver transplant
in the United States. It is primarily a female disease, afflicting
approximately one in 1,000 women over the age of 40. Clinically, the progress
of the disease is assessed by measuring the blood levels of alkaline
phosphatase (ALP) and bilirubin, which have been shown to correlate with risk
of adverse outcomes. Ursodiol is the only approved drug treatment for PBC and
studies have shown that up to 50% of PBC patients fail to respond adequately,
thereby remaining at risk of adverse outcomes.

The POISE trial is studying the safety and efficacy of a once daily dose of
OCA in PBC patients with an inadequate therapeutic response to, or who are
unable to tolerate, ursodiol. Patients were randomized to one of three groups
in the study: 5mg, 10mg or placebo. The primary endpoint of the 12-month
double–blind portion of the trial is the achievement of both an ALP level of
less than 1.67 times upper limit normal (with at least a 15% reduction from
baseline) and a normal bilirubin level, as compared to placebo. Patients with
ALP and bilirubin levels below these thresholds have been shown in long-term
clinical studies to have a significantly lower risk of progressing to liver
transplant and death.All of the patients will be allowed to participate in a
long-term extension of the trial during which patients are expected to be
treated with OCA for five years.

Additional information regarding the POISE trial can be found on the NIH
clinical study listing web site:

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 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. Intercept owns
worldwide rights to OCA outside of Japan and China, where it has out-licensed
the product candidate to Dainippon Sumitomo Pharma (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 POISE trial
will be available, Intercept's plans to seek regulatory approval of OCA for
PBC and the utility of the endpoints and results of the POISE trial in seeking
such approval, Intercept's plans for a long-term extension study of OCA in
PBC, 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
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