Business Overview

9 Months Ended

Sep. 30, 2015

Business Overview

Business Overview

1. Business Overview

Synergy Pharmaceuticals Inc. (the “Company” or ‘Synergy”) is a biopharmaceutical company focused on the development and commercialization of novel gastrointestinal (GI) therapies. Our proprietary GI platform includes two fully-owned, late-stage clinical assets - plecanatide and dolcanatide. We designed both plecanatide and dolcanatide to be pharmacologically superior versions of the naturally occurring human GI peptide, uroguanylin, which is an important regulator for digestive fluid movement and gut health. Plecanatide is our first novel uroguanylin analog being developed for chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). Taken as a tablet once-a-day, plecanatide is designed to mimic the natural role of uroguanylin by working locally in the upper GI tract to activate and regulate fluid movement required for normal bowel function. In the summer of 2015, we announced positive phase 3 data from two plecanatide clinical trials for CIC. We intend to file our first new drug application (NDA) with plecanatide in the CIC indication in January 2016. Plecanatide is also being evaluated in two ongoing pivotal phase 3 clinical trials for IBS-C. We intend to file our second NDA with plecanatide in the IBS-C indication by year-end 2016. Dolcanatide is our second novel uroguanylin analog currently being evaluated in a phase 1b exploratory study for the treatment of ulcerative colitis. Dolcanatide is designed to have enhanced resistance to proteolysis in intestinal fluid relative to uroguanylin and yet still retain the same physiologic characteristics as natural uroguanylin. In November 2014, we announced positive data with dolcanatide from a phase 2 clinical trial for opioid-induced constipation (OIC).