Appointment Positions Intercept for Next Phase of Growth as it Plans for Commercialization of OCA for PBC and NASH
NEW YORK, 19 February 2015 - 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 Lisa Bright has been promoted to the newly-created position of Chief Commercial and Corporate Affairs Officer. Ms. Bright joined Intercept last year from Gilead Sciences where her leadership of the European launch of Sovaldi for the treatment of chronic hepatitis C contributed to the most successful product launch in pharmaceutical history.
Intercept's first product is obeticholic acid (OCA), a first-in-class FXR agonist being developed for primary biliary cirrhosis (PBC), nonalcoholic steatohepatitis (NASH) and other chronic liver indications. The company has initiated a rolling New Drug Application with the FDA in PBC and is planning for the commercial launch of OCA in PBC in the U.S. and Europe in 2016. OCA was also recently designated a breakthrough therapy by FDA for the treatment of NASH with liver fibrosis.
"Lisa has a wealth of experience in building a global hepatology franchise that is directly relevant to planning and implementing OCA's launch," said Dr. Mark Pruzanski, M.D., President and CEO of Intercept. "Lisa has been a great addition to the senior management team as we position Intercept to become the leader in addressing the unmet needs of innumerable patients with neglected liver diseases worldwide who currently have very limited treatment options."
In her new role, Ms. Bright will lead the company's Commercial organization and a newly created Corporate Affairs group focused on government and public affairs, as well as patient advocacy. Ms. Bright replaces Dan Regan, a 20-year pharmaceutical industry veteran, who is leaving the company. "I want to thank Dan for all of his contributions in creating the foundation for our upcoming PBC launch and wish him continued success," said Dr. Pruzanski.
Prior to joining Intercept, Ms. Bright held positions of increasing responsibility at Gilead Sciences, including Vice President, Northern Europe, and most recently Vice President, Head of Sovaldi Launch Planning for Europe, Asia, Middle East and Australasia and Vice President, Head Government Affairs for Europe, Middle East and Australasia. Prior to Gilead, she held a range of senior leadership positions over a 10-year tenure at GSK, including Vice President & Managing Director of GSK's New Zealand operations and Vice President and Head of Sales, UK.
Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat chronic liver diseases utilizing its expertise in bile acid chemistry. The company's lead product candidate, OCA, is a bile acid analog and first-in-class agonist of the farnesoid X receptor (FXR). OCA is being developed for a variety of chronic liver diseases including PBC, NASH and PSC. OCA has received breakthrough therapy designation from the FDA for the treatment of NASH with fibrosis. 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: www.interceptpharma.com.
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 commercialization of OCA and the timing thereof, our potential development and regulatory milestones and the timeframes under which we anticipate such milestones may be achieved, 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; the election by our collaborators to pursue research, development and commercialization activities; our ability to attract collaborators with development, regulatory and commercialization expertise; our ability to obtain and maintain intellectual property protection for its 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; 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, 2013 filed on March 14, 2014 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.
Sue CharlesManaging Partner