Healthcare Industry News:  sclerosing cholangitis 

Biopharmaceuticals FDA

 News Release - August 31, 2015

FDA Grants Priority Review for Intercept's Obeticholic Acid for the Treatment of Primary Biliary Cirrhosis

NEW YORK, Aug. 31, 2015 -- (Healthcare Sales & Marketing Network) -- Intercept Pharmaceuticals, Inc. (ICPT) (Intercept), a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat chronic underserved liver diseases, today announced the U.S. Food and Drug Administration (FDA) has accepted for review the company's New Drug Application and granted Priority Review for obeticholic acid (OCA) for the treatment of primary biliary cirrhosis (PBC).

OCA is being developed to treat PBC patients with an inadequate therapeutic response to, or who are unable to tolerate, ursodeoxycholic acid (UDCA), the only drug currently approved to treat PBC. The FDA has set a target date of February 29, 2016 to take action under the Prescription Drug User Fee Act (PDUFA).

"Despite current treatment, PBC remains a leading cause of liver transplant among women, so there is a clear ongoing high unmet medical need for new therapies for patients with PBC," said Mark Pruzanski, M.D., President and Chief Executive Officer. "Priority review designation accelerates the FDA review timelines, potentially bringing Intercept closer to its goal of delivering the first new medicine for PBC in close to 20 years. We look forward to working with FDA to bring OCA to PBC patients in need as soon as possible."

The FDA grants Priority Review to medicines that, if approved, would be a significant improvement in the safety or effectiveness of treatment, prevention or diagnosis of serious diseases. A priority review designation means FDA's goal is to take action on the marketing application within six months of acceptance as compared to 10 months under standard review. OCA was previously granted Fast Track designation by FDA. A drug development program with Fast Track designation is afforded greater access to FDA for the purpose of expediting the drug's development, review and potential approval.

About Primary Biliary Cirrhosis

PBC is a rare liver disease that primarily results from autoimmune destruction of the bile ducts that transport bile acids out of the liver, resulting in cholestasis. It is primarily a disease of women, afflicting approximately one in 1,000 women over the age of 40. PBC is a leading cause of liver transplant among women in the United States. In Europe, the disease accounts for approximately half of liver transplants due to cholestatic diseases and 6% of all liver transplants.

About Intercept

Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat chronic underserved 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 (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. 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 approval and launch of OCA in PBC and timelines related there to 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 our 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; the election by our collaborators to pursue research, development and commercialization activities; our ability to attract collaborators with development, regulatory and commercialization expertise; 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, 2014 filed on March 2, 2015, our quarterly report on Form 10-Q for the period ended June 30, 2015 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.

Source: Intercept Pharmaceuticals

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