NEW YORK, Aug. 9, 2012 /PRNewswire/ -- Intercept Pharmaceuticals, Inc., a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat chronic liver diseases, today announced the completion of a $30 million Series C preferred stock financing led by OrbiMed Advisors LLC, a leading global healthcare investment firm, with existing majority investor Genextra S.p.A. also participating. In conjunction with the financing, OrbiMed's Jonathan Silverstein and Klaus Veitinger, MD, have joined Intercept's Board of Directors.
"This financing allows us to continue advancing our lead compound OCA in POISE, our Phase 3 PBC trial, while pursuing other therapeutic indications of interest," commented Mark Pruzanski, MD, Intercept's president and chief executive officer. "We welcome Jonathan and Klaus to the Board and are excited to benefit from the experience they bring."
"We are very pleased to become involved with a company of Intercept's caliber," added Jonathan Silverstein for OrbiMed. "We are particularly interested in products focused on orphan indications and believe that OCA has great potential as a novel therapy for PBC and other indications. We look forward to working with Mark and his team to help the company build its pipeline and achieve its full potential."
Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat orphan and more prevalent liver diseases utilizing its expertise in bile acid chemistry. The company's lead product candidate, obeticholic acid, or OCA, is a bile acid analog and first-in-class agonist of the farnesoid X receptor (FXR). OCA is initially being developed for the second line treatment of primary biliary cirrhosis (PBC) in patients with an inadequate response to, or who are unable to tolerate, ursodiol, the only approved therapy for this indication. PBC is a chronic autoimmune liver disease that may progress to cirrhosis and liver failure, and it is currently the fifth leading indication for liver transplant in the United States. OCA has orphan drug designation in both the United States and Europe for the treatment of PBC. Intercept owns worldwide rights to OCA outside of Japan and China, where it has out-licensed the product candidate to Dainippon Sumitomo Pharma (DSP).
Intercept is currently conducting POISE, a Phase 3 clinical trial of OCA in PBC. The target enrollment in POISE is 180 patients who first enter a one year double-blind placebo-controlled pivotal trial phase, followed by an open label long-term safety extension phase for another five years. The primary endpoint of the pivotal phase is the achievement of an alkaline phosphatase (ALP) level of less than 1.67 times upper limit normal (with at least a 15% reduction in ALP), together with a normal bilirubin level. Patients who attain these ALP and bilirubin thresholds have been shown in long-term studies to be at significantly lower risk of progressing to liver transplant and death.
OrbiMed is a leading investment firm dedicated exclusively to the healthcare sector, with approximately $6 billion in assets under management. OrbiMed invests across the spectrum of healthcare companies on a worldwide basis. OrbiMed's team includes over 60 experienced professionals with offices in New York City, San Francisco, Shanghai, Mumbai and Herzliya. OrbiMed seeks to be a capital provider of choice, bringing the global resources required to be an excellent long‐term partner for building world‐class healthcare companies.
Genextra is a Milan, Italy based holding company with majority investments in several life sciences companies founded on intellectual property generated in Italy. Genextra was created in 2004 by a group of prominent Italian entrepreneurs and financial institutions in partnership with leading scientists from the European Institute of Oncology (IEO).
SOURCE Intercept Pharmaceuticals, Inc.