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 Synergy Pharmaceuticals Inc. SGYP announced today that the 
 company will present new data from an analysis of patients with moderate 
 to very severe bloating at baseline who participated in two Phase 3 
 studies evaluating TRULANCE™ (plecanatide) for the treatment of adults 
 with chronic idiopathic constipation (CIC). These data were recognized 
 by the American Gastroenterology Association (AGA) as a Poster of 
 Distinction and will be presented at Digestive Disease Week (DDW), May 
 6-9, 2017, in Chicago.
 
 
 TRULANCE is a once-daily tablet approved by the Food and Drug 
 Administration (FDA) for the treatment of adults with CIC and is 
 currently being evaluated for the treatment of adults with IBS-C. The 
 recommended dosage of TRULANCE for CIC is 3 mg taken orally, once daily, 
 with or without food at any time of the day.
 
 
 Over 12 weeks, patients with CIC and moderate, severe or very severe 
 bloating symptoms at baseline and were treated with TRULANCE 3 mg or 6 
 mg doses achieved a significantly greater efficacy responder rate—the 
 primary endpoint defined by the FDA for regulatory approval in CIC—in 
 this analysis compared to placebo (18.8% for 3 mg and 16.3% for 6 mg 
 compared to 9.5% for placebo). Efficacy responders were defined as 
 patients who had at least three complete spontaneous bowel movements 
 (CSBMs) in a given week and an increase of at least one CSBM over 
 baseline in the same week for at least nine weeks out of the 12-week 
 treatment period, including at least three of the last four weeks. The 
 symptom of bloating among these patients also showed statistically 
 significant improvements for TRULANCE 3 mg and 6 mg compared to placebo. 
 Improvements in abdominal bloating scores were statistically significant 
 after one week and continued throughout the 12-week treatment period.
 
 
 "People living with chronic idiopathic constipation often experience a 
 range of symptoms that can make it more difficult to manage this 
 disorder, including moderate to very severe bloating," said Satish S.C. 
 Rao, M.D., Ph.D., Professor of Medicine, Division Chief Fellowship 
 Program Director and Director, Digestive Health Center at Augusta 
 University. "The data presented today is consistent with the efficacy 
 and safety results seen from previously published results for TRULANCE 
 in CIC."
 
 
 In both studies, the most common adverse event was diarrhea (4.1% at 3 
 mg and 4.5% at 6 mg compared to 0.7% for placebo). Discontinuation rates 
 were low across both groups (3.6% at 3 mg and 4.5% at 6 mg compared to 
 2.4% for placebo) and discontinuations due to diarrhea were infrequent 
 (1.0% at 3 mg and 1.6% at 6 mg compared to 0.2% for placebo).
 
 
 Indications and Usage
 
 
 TRULANCE is a guanylate cyclase-C (GC-C) agonist indicated in adults for 
 the treatment of chronic idiopathic constipation (CIC).
 
 
 IMPORTANT SAFETY INFORMATION
 
 
 WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS
 
 
 Trulance™ is contraindicated in patients less than 6 years of age; in 
 nonclinical studies in young juvenile mice administration of a single 
 oral dose of plecanatide caused deaths due to dehydration. Use of 
 Trulance should be avoided in patients 6 years to less than 18 years of 
 age. The safety and efficacy of Trulance have not been established in 
 pediatric patients less than 18 years of age.
 
 
 Contraindications
 
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 Trulance is contraindicated in patients less than 6 years of age due 
 to the risk of serious dehydration.
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 Trulance is contraindicated in patients with known or suspected 
 mechanical gastrointestinal obstruction.
 </li>
 </ul>
 
 Warnings and Precautions
 
 
 Risk of Serious Dehydration in Pediatric Patients
 
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 Trulance is contraindicated in patients less than 6 years of age. The 
 safety and effectiveness of Trulance in patients less than 18 years of 
 age have not been established. In young juvenile mice (human age 
 equivalent of approximately 1 month to less than 2 years), plecanatide 
 increased fluid secretion as a consequence of stimulation of guanylate 
 cyclase-C (GC-C), resulting in mortality in some mice within the first 
 24 hours, apparently due to dehydration. Due to increased intestinal 
 expression of GC-C, patients less than 6 years of age may be more 
 likely than older patients to develop severe diarrhea and its 
 potentially serious consequences.
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 Use of Trulance should be avoided in patients 6 years to less than 18 
 years of age. Although there were no deaths in older juvenile mice, 
 given the deaths in young mice and the lack of clinical safety and 
 efficacy data in pediatric patients, use of Trulance should be avoided 
 in patients 6 years to less than 18 years of age.
 </li>
 </ul>
 
 Diarrhea
 
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 Diarrhea was the most common adverse reaction in the two 
 placebo-controlled clinical trials. Severe diarrhea was reported in 
 0.6% of patients.
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 If severe diarrhea occurs, the health care provider should suspend 
 dosing and rehydrate the patient.
 </li>
 </ul>
 
 Adverse Reactions
 
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 In the two combined CIC clinical trials, the most common adverse 
 reaction in Trulance-treated patients (incidence ≥2% and greater than 
 in the placebo group) was diarrhea (5% vs 1% placebo).
 </li>
 </ul>
 
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 Full Prescribing Information.
 
 
 About Chronic Idiopathic Constipation (CIC)
 
 
 CIC affects approximately 14 percent of the global population, 
 disproportionately affecting women and older adults. People with CIC 
 have persistent symptoms of difficult-to-pass and infrequent bowel 
 movements. In addition to physical symptoms including abdominal bloating 
 and discomfort, CIC can adversely affect an individual's quality of 
 life, including increasing stress levels and anxiety.
 
 
 About TRULANCE™
 
 
 TRULANCE™ (plecanatide) is a once-daily tablet approved for 
 adults with CIC and is being evaluated for IBS-C. With the exception of 
 a single amino acid substitution for greater binding affinity, TRULANCE 
 is structurally identical to uroguanylin, a naturally occurring and 
 endogenous human GI peptide. Uroguanylin activates GC-C receptors in a 
 pH-sensitive manner primarily in the small intestine, stimulating fluid 
 secretion and maintaining stool consistency necessary for regular bowel 
 function.
 
 
 About Synergy Pharmaceuticals
 
 
 Synergy is a biopharmaceutical company focused on the development and 
 commercialization of novel GI therapies. The company has pioneered 
 discovery, research and development efforts on analogs of uroguanylin, a 
 naturally occurring and endogenous human GI peptide, for the treatment 
 of GI diseases and disorders. Synergy's proprietary GI platform includes 
 one commercial product TRULANCE and a second lead product candidate, 
 dolcanatide. For more information, please visit <a xmlns="http://www.w3.org/1999/xhtml" href="http://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.synergypharma.com&amp;esheet=51554537&amp;newsitemid=20170507005038&amp;lan=en-US&amp;anchor=www.synergypharma.com&amp;index=2&amp;md5=ca5af03720a2843b573316f32a492876" rel="nofollow" rel="nofollow">www.synergypharma.com</a>.
 
 
 Forward-Looking Statement
 
 
 This press release and any statements made for and during any 
 presentation or meeting contain forward-looking statements related to 
 Synergy Pharmaceuticals Inc. under the safe harbor provisions of Section 
 21E of the Private Securities Litigation Reform Act of 1995 and are 
 subject to risks and uncertainties that could cause actual results to 
 differ materially from those projected. These statements may be 
 identified by the use of forward-looking words such as &#34;anticipate,&#34; 
 &#34;planned,&#34; &#34;believe,&#34; &#34;forecast,&#34; &#34;estimated,&#34; &#34;expected,&#34; and &#34;intend,&#34; 
 among others. There are a number of factors that could cause actual 
 events to differ materially from those indicated by such forward-looking 
 statements. These factors include, but are not limited to, the 
 development, launch, introduction and commercial potential of TRULANCE; 
 growth and opportunity, including peak sales and the potential demand 
 for TRULANCE, as well as its potential impact on applicable markets; 
 market size; substantial competition; our ability to continue as a going 
 concern; our need for additional financing; uncertainties of patent 
 protection and litigation; uncertainties of government or third party 
 payer reimbursement; dependence upon third parties; our financial 
 performance and results, including the risk that we are unable to manage 
 our operating expenses or cash use for operations, or are unable to 
 commercialize our products, within the guided ranges or otherwise as 
 expected; and risks related to failure to obtain FDA clearances or 
 approvals and noncompliance with FDA regulations. As with any 
 pharmaceutical under development, there are significant risks in the 
 development, regulatory approval and commercialization of new products. 
 There are no guarantees that future clinical trials discussed in this 
 press release will be completed or successful or that any product will 
 receive regulatory approval for any indication or prove to be 
 commercially successful. Investors should read the risk factors set 
 forth in Synergy&#39;s most recent periodic reports filed with the 
 Securities and Exchange Commission, including Synergy's Form 10-K for 
 the year ended December 31, 2016. While the list of factors presented 
 here is considered representative, no such list should be considered to 
 be a complete statement of all potential risks and uncertainties. 
 Unlisted factors may present significant additional obstacles to the 
 realization of forward-looking statements. Forward-looking statements 
 included herein are made as of the date hereof, and Synergy does not 
 undertake any obligation to update publicly such statements to reflect 
 subsequent events or circumstances except as required by law.
 
 
 
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Synergy Pharmaceuticals to Present TRULANCE™ (Plecanatide) Phase 3 Data at Digestive Disease Week (DDW) for the Treatment of Adults with Chronic Idiopathic Constipation (CIC) with Moderate to Very Severe Bloating 

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Synergy Pharmaceuticals to Present TRULANCE™ (Plecanatide) Phase 3 Data at Digestive Disease Week (DDW) for the Treatment of Adults with Chronic Idiopathic Constipation (CIC) with Moderate to Very Severe Bloating


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