Intercept Pharmaceuticals Announces Completion of Enrollment in FLINT

Intercept Pharmaceuticals Announces Completion of Enrollment in FLINT

NEW YORK, Nov. 12, 2012 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc.
(Nasdaq:ICPT) (Intercept), a clinical stage biopharmaceutical company focused
on the development and commercialization of novel therapeutics to treat
chronic liver diseases, has been informed by the National Institute of
Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes
of Health that patient enrollment in the FLINT trial has been completed. FLINT
is a double blind, placebo controlled, multi-center Phase 2b clinical trial
evaluating the treatment effects of OCA compared with placebo in adult
nonalcoholic steatohepatitis (NASH) patients. 

"We are thrilled that FLINT has completed enrollment as this is the largest
NASH trial yet conducted.There are no approved therapies for NASH, the most
prevalent liver disease in the developed world, and accordingly there is a
very high medical need for treating these patients," said Mark Pruzanski, MD,
Chief Executive Officer of Intercept.

About FLINT

FLINT has enrolled 280 patients at the eight U.S. centers comprising the
NIDDK-sponsored NASH clinical research network.Patients have been randomized
to receive either a 25mg dose of OCA or placebo. The primary endpoint in the
72-week trial will be evaluated by liver biopsy and is defined as an
improvement in the NAFLD activity score with no worsening of liver fibrosis.
NIDDK is providing the majority of funding for the trial and is partnering
with Intercept under a cooperative research and development agreement. Further
details can be found at http://clinicaltrial.gov/ct2/show/NCT01265498.

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. PBC is a
chronic 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. OCA has 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 outlicensed the product candidate
to Dainippon Sumitomo Pharma (DSP). For more information about Intercept,
please visit the Company's website at: www.interceptpharma.com.

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 OCA's potential to treat portal hypertension, the utility of the
endpoints of the PESTO trial 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 prospectus dated October 10, 2012 filed with
the Securities and Exchange Commission pursuant to Rule 424(b) of the
Securities Act of 1933, as amended, as well as any updates to these risk
factors filed from time to time in Intercept's Quarterly Reports on Form 10-Q
or Current Reports on Form 8-K and 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: Mark Pruzanski, M.D.,
         Barbara Duncan
         Intercept Pharmaceuticals
         1-646-747-1000
 
Press spacebar to pause and continue. Press esc to stop.