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October 08, 2015 7:14 PM ET


Company Overview of Intercept Pharmaceuticals, Inc.

Company Overview

Intercept Pharmaceuticals, Inc., a development stage biopharmaceutical company, focuses on the discovery, development, and commercialization of novel therapeutics to treat chronic liver and intestinal diseases utilizing its proprietary bile acid chemistry. It primarily develops obeticholic acid (OCA), a bile acid analog that completed Phase III clinical trial for the treatment of primary biliary cirrhosis; is in Phase III clinical trial for the treatment of nonalcoholic steatohepatitis; is in Phase 2 clinical trial for primary sclerosing cholangitis; and is in Phase I clinical trial for the treatment of biliary atresia. The company’s product candidates in preclinical stage include INT-767, a...

450 West 15th Street

Suite 505

Floor 5

New York, NY 10011

United States

Founded in 2002

203 Employees





Key Executives for Intercept Pharmaceuticals, Inc.

Founder, Chief Executive Officer, President and Director
Age: 47
Total Annual Compensation: $934.0K
Chief Financial Officer, Treasurer and Secretary
Age: 50
Total Annual Compensation: $556.9K
Chief Medical Officer and Executive Vice President of Development
Age: 61
Total Annual Compensation: $626.5K
Compensation as of Fiscal Year 2013.

Intercept Pharmaceuticals, Inc. Key Developments

Intercept Pharmaceuticals, Inc. Announces Initiation of the REGENERATE Trial for Obeticholic Acid in NASH Patients

Intercept Pharmaceuticals, Inc. announced the initiation of the REGENERATE trial, an international Phase 3 trial of obeticholic acid (OCA), the company's lead FXR agonist, in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with advanced liver fibrosis. OCA is the first NASH therapy to have demonstrated reversal of liver fibrosis with a significantly greater therapeutic response versus placebo in patients at higher risk of progression to cirrhosis. The U.S. Food and Drug Administration (FDA) has designated OCA as a breakthrough therapy in NASH patients with fibrosis and REGENERATE was designed in accordance with advice from the FDA and European Medicines Agency (EMA). The REGENERATE study population will be primarily comprised of NASH patients with stage 2 or stage 3 liver fibrosis. Advanced liver fibrosis has been shown to be the best predictor of liver transplant and mortality in patients with NASH. In addition, the trial will include an exploratory cohort of NASH patients with early stage 1 liver fibrosis and concomitant diabetes, obesity or elevated alanine aminotransferase (ALT) who are at increased risk of progression to cirrhosis. REGENERATE has been designed as a double-blind, placebo-controlled Phase 3 clinical trial expected to enroll approximately 2,000 NASH patients at up to 300 qualified centers worldwide and assess the potential benefits of OCA treatment on liver-related and other clinical outcomes. The trial will include a pre-planned interim histology analysis after 72 weeks of treatment in 1,400 patients, which is intended to serve as the basis for seeking initial U.S. and international marketing approvals of OCA for the treatment of NASH patients with fibrosis. Two co-primary endpoints will be assessed in the interim analysis: (i) fibrosis improvement with no worsening of NASH and (ii) NASH resolution with no worsening of fibrosis.

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

Intercept Pharmaceuticals, Inc. 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. 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.

Intercept Pharmaceuticals, Inc. Announces Consolidated Earnings Results for the Second Quarter and Six Months Ended June 30, 2015

Intercept Pharmaceuticals, Inc. announced consolidated earnings results for the second quarter and six months ended June 30, 2015. For the quarter, the company reported licensing revenue of $445,000 compared to $445,000 a year ago. Net loss was $47,894,000 or $1.99 per diluted share compared to net income of $33,470,000 or $1.51 per diluted share a year ago. For the six months, the company reported licensing revenue of $1,891,000 compared to $851,000 a year ago. Net loss was $87,280,000 or $3.78 per basic and diluted share compared to $212,559,000 or $10.50 per basic and diluted share a year ago.

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