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Intercept Pharmaceuticals Announces 2012 Financial Results And Provides Business Update

Stocks in this article: ICPT

Continued Development Progress and a Strong Cash Position  

Conference Call Scheduled Today at 5:30 p.m. ET

NEW YORK, March 18, 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 reported financial results for the fourth quarter and full year ended December 31, 2012 and provided an update on corporate developments.

"2012 was an extraordinary year for Intercept with the significant progress we made advancing our lead product candidate OCA, while raising over $115 million in equity capital through the completion of our Series C financing and IPO, which improved our cash position while diversifying our stockholder base. These accomplishments have set the stage for what we expect will be an important year in 2013 as we move toward completion of our Phase 3 POISE trial in PBC and build further on the analyses from two large international clinical data sets closely correlating the biochemical response we are evaluating in POISE with clinical outcomes," said Mark Pruzanski, M.D., Chief Executive Officer and President of Intercept.

OCA Development

Completion of Enrollment in POISE

We completed enrollment of POISE in December 2012. By randomizing 217 patients, we exceeded the target of 180 patients by approximately 20% while completing enrollment in POISE more than three months faster than originally anticipated. The demographics and baseline disease characteristics of the patients enrolled are similar to those seen in our Phase 2 trial of OCA as a combination therapy in PBC patients. Results from the 12-month double-blind portion of POISE are anticipated to be available in the second quarter of 2014.

Strong Statistical Correlation of PBC Endpoint with Clinical Outcomes

We are sponsoring an independent study involving at least 15 leading PBC centers worldwide, collectively named the Global PBC Study Group, that are pooling their long-term patient data to further corroborate the ability of the biochemical parameters alkaline phosphatase (ALP) and bilirubin to predict clinical outcomes such as liver transplant and death. We anticipate data from at least 4,000 patients will be collected and analyzed as part of this study. Results for more than 2,100 patients will be disclosed in a poster presentation at the annual meeting of the European Association for the Study of the Liver (EASL) to be held in April 2013. The analysis confirms that the POISE trial primary endpoint, a composite of ALP and bilirubin, has a highly statistically significant correlation with improved long-term liver transplant-free survival. We anticipate that final results will be available by the end of 2013 and will support what we believe is an emerging consensus among PBC opinion leaders concerning the clinical utility of our selected endpoint.

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