Intercept Pharmaceuticals Inc was incorporated in the State of Delaware on September 4, 2002. It is a biopharmaceutical company, engaged in the development and commercialization of novel therapeutics to treat chronic liver disease utilizing its proprietary bile acid chemistry. The Company's product candidates have the potential to treat orphan and more prevalent liver diseases for which there currently are limited therapeutic solutions. The Company's product candidate, obeticholic acid, or OCA, is a bile acid analog, a chemical substance that has a structure based on a naturally occurring human bile acid. OCA is a first-in-class product candidate that selectively binds to and induces activity in the farnesoid X receptor, or FXR, which it believes has broad liver-protective properties. The Company is developing OCA initially for primary biliary cirrhosis, or PBC, as a second line treatment for patients who have an inadequate response to or who are unable to tolerate standard of care therapy and therefore need additional treatment. PBC is a chronic autoimmune liver disease that, if inadequately treated, may eventually lead to cirrhosis, liver failure and death. The Company is conducting a Phase 3 clinical trial of OCA in PBC, which it calls the POISE trial that it anticipate will serve as the basis for seeking regulatory approval in the United States and Europe. The Company currently expects results from the trial to be available by mid-2014. OCA has received orphan drug designation in the United States and Europe for the treatment of PBC. The Company owns the rights to OCA outside of Japan and China, where it has exclusively licensed the compound to Dainippon Sumitomo Pharma, or DSP, and granted it an option to exclusively license OCA in certain other Asian countries. Some of the competitors are Eli Lilly, Exelixis, Inc. and Phenex Pharmaceuticals AG. Governmental authorities in the United States, at the federal, state and local level, and other countries extensively regulate, among other things, the research, development, testing, manufacture, labeling, packaging, promotion, storage, advertising, distribution, marketing and export and import of products such as those it is developing.