NEW YORK, April 16, 2016 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals Inc. (Nasdaq:ICPT), a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat non-viral, progressive liver diseases, today announced the winners of its Practice to Policy Health Awards Program. Practice to Policy offers financial support to local and national projects in primary biliary cirrhosis, recently renamed primary biliary cholangitis (PBC), that create valuable insights, evidence and learning for the wider healthcare community across Europe, the United States and Canada. The winners were announced at the International Liver Congress 2016 of the European Association for the Study of the Liver (EASL, 13-17 April 2016).
In its inaugural year, the grants program received 36 applications from 11 countries. From this diverse group of submissions, a total of 20 winning organizations will receive Practice to Policy grants in 2016, with financial support typically ranging between $10,000 and $25,000. The winning institutions include academic centers, healthcare organizations and patient advocates, reflecting the key stakeholder groups that can play a role in improving PBC care.
“We’re committed to understanding the social, behavioral, educational and economic factors that impact PBC care, and this is where we hope the Practice to Policy program can make a difference,” said Lisa Bright, Intercept’s Chief Commercial & Corporate Affairs Officer. “It has been exciting to see such an enthusiastic response to this program from the PBC community and I am looking forward to seeing the evolution and outcomes of these projects as they move from concept to execution.”
PBC experts and patient advocacy group leaders from both Europe and the U.S. participated in the evaluation of applications and guided Intercept in its selection of the winning proposals. Winning projects will address topics ranging from online learning platforms for physicians to peer-to-peer support programs and educational apps for the patient community.
Importantly, the winners of Practice to Policy grants will report back on their project outcomes one year after receiving the funds, enabling the broader community to learn from their projects and to grow the knowledge base of best practices for optimizing PBC care and patient support.
A full list of the winning projects can be found at www.interceptpracticetopolicy.com.
About Primary Biliary Cirrhosis, recently renamed Primary Biliary Cholangitis
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. Since 1988, PBC has been the second-leading overall cause of liver transplant in women in the United States, behind hepatitis C. In Europe, the disease accounts for approximately half of liver transplants due to cholestatic diseases and 6% of all liver transplants.
Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat non-viral, progressive liver diseases. The Company's lead product candidate, obeticholic acid (OCA), is a novel farnesoid X receptor (FXR) agonist. OCA is being developed to treat a variety of chronic liver diseases, including primary biliary cirrhosis, recently renamed primary biliary cholangitis (PBC), non-alcoholic steatohepatitis (NASH), primary sclerosing cholangitis (PSC), and biliary atresia (BA). 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. Intercept's pipeline of product candidates includes other novel bile acid analogs such as INT-767, which is in clinical development. 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 Ocaliva in PBC, the anticipated prevalence of PBC, the continued development of Ocaliva and Intercept's other product candidates, 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 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, which may be affected by the reimbursement that our products receive from payors; 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 collaborators' election to pursue research, development and commercialization activities; our ability to attract collaborators with development, regulatory and commercialization expertise; our need for and ability to obtain additional financing; our estimates regarding expenses, future revenues and capital requirements and the accuracy thereof; our use of cash and short term investments; and our ability to attract and 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, 2015 filed on February 29, 2016 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.
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