Business Overview

6 Months Ended

Jun. 30, 2015

Business Overview

Business Overview

1. Business Overview

Synergy Pharmaceuticals Inc. (the “Company” or ‘Synergy”) is a biopharmaceutical company focused on the development of novel therapies to treat gastrointestinal (GI) diseases and disorders. Our proprietary GI platform is based on uroguanylin, a naturally occurring human peptide that plays a key role in regulating normal GI activity. We discovered and are developing two fully-owned late-stage clinical assets, plecanatide and dolcanatide (formerly SP-333), which are both analogues of natural uroguanylin. Plecanatide is our first generation uroguanylin analogue being developed for both chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). Plecanatide is structured identical to uroguanylin with the exception of a single key amino acid substitution, resulting in improved activity but still retaining attribute of uroguanylin that are important for natural pH-regulated activity. Taken as a tablet once-a-day, plecanatide is designed to mimic the role of uroguanylin by working locally in the upper GI tract to activate and regulate fluid movement required for normal bowel function. We recently announced positive top-line data results in two phase 3 clinical trials of plecanatide in patients with CIC and we intend to file our first new drug application (NDA) with plecanatide in the CIC indication in January 2016. We are continuing to progress our two ongoing phase 3 clinical trials of plecanatide in patients with IBS-C and we intend to file our second NDA with plecanatide in the IBS-C indication in 4Q 2016. Dolcanatide is our next generation uroguanylin analogue designed to be highly stable and resistant to proteolysis in gastric and intestinal fluids but still operate in the same pH-dependent fashion as uroguanylin. Dolcanatide has successfully completed a phase 2 clinical trial in patients with opioid-induced constipation and is currently being evaluated in a phase 1b exploratory study for ulcerative colitis.