Pivotal Phase 3 Data Results for TRULANCE™ (plecanatide) in the Treatment of Chronic Idiopathic Constipation (CIC) Published in American Journal of Gastroenterology

NEW YORK–(BUSINESS WIRE)– Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) today announced that the American
Journal of Gastroenterology has published detailed results from a
pivotal Phase 3 trial that demonstrated the efficacy and safety of
TRULANCE^™ (plecanatide) for the treatment of adults
with chronic idiopathic constipation (CIC).

On Jan. 19, TRULANCE was approved by the U.S. Food and Drug
Administration (FDA) for the treatment of adult patients with CIC.
TRULANCE is the first drug designed to replicate the function of
uroguanylin, a naturally occurring and endogenous human gastrointestinal
(GI) peptide that is thought to stimulate fluid secretion within the
changing pH environment of the intestine.

“We are very pleased that our pivotal Phase 3 results are appearing in
the American Journal of Gastroenterology, as these robust data
demonstrate the efficacy and safety profile of TRULANCE, and add
momentum to the FDA’s recent approval of TRULANCE,” said Gary S. Jacob,
Ph.D., Chairman and CEO of Synergy Pharmaceuticals Inc. “The publication
of these data are a testament to the dedication of our researchers and
the hard work of our entire Synergy team, all of whom are excited to be
bringing TRULANCE to healthcare providers and their patients with the
upcoming launch of this drug.”

TRULANCE will be available in the U.S. this quarter.

“There are millions of CIC patients in the U.S., many of whom suffer
with symptoms that remain untreated or fail to respond to current
treatments,” said Satish S.C. Rao, M.D., Ph.D., Professor of Medicine
and Director, Neurogastroenterology/Motility, Digestive Health Center at
Augusta University. “TRULANCE has demonstrated efficacy with a low rate
of adverse events, such as diarrhea, providing healthcare providers and
their patients with an additional, much needed, new treatment option.”

In this study, diarrhea was the most common adverse event (TRULANCE 3
mg, 5.9%; placebo, 1.3%).

The approved dosing regimen for TRULANCE is 3 mg taken orally, once
daily, with or without food at any time of the day. TRULANCE can be
swallowed whole or crushed in applesauce for those who are unable to
swallow medication.

Synergy has also completed two Phase 3 clinical trials for TRULANCE in
irritable bowel syndrome with constipation (IBS-C), with positive
top-line results of these trials announced in December 2016. Synergy
plans to file a New Drug Application Supplement with Clinical Data
(sNDA) this quarter with an expected 10-month review period from
submission.

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

• Trulance is contraindicated in patients less than 6 years of age due
  to the risk of serious dehydration.
• Trulance is contraindicated in patients with known or suspected
  mechanical gastrointestinal obstruction.

Warnings and Precautions

Risk of Serious Dehydration in Pediatric Patients

• 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.
• 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.

Diarrhea

• Diarrhea was the most common adverse reaction in the two
  placebo-controlled clinical trials. Severe diarrhea was reported in
  0.6% of patients.
• If severe diarrhea occurs, the health care provider should suspend
  dosing and rehydrate the patient.

Adverse Reactions

• 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).

Please click here
for 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, TRULANCE is structurally related to uroguanylin, a
naturally occurring and endogenous human GI peptide. Uroguanylin is
thought to act in a pH-sensitive manner, targeting GC-C receptors
primarily in the small intestine coinciding with areas of fluid
secretion.

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 human GI peptide, for the treatment of GI diseases
and disorders. Synergy’s proprietary uroguanylin analog platform
includes one commercial product TRULANCE (plecanatide) and a second lead
product candidate – dolcanatide. For more information, please visit www.synergypharma.com.

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 « anticipate, »
« planned, » « believe, » « forecast, » « estimated, » « expected, » and « intend, »
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’s most recent periodic reports filed with the
Securities and Exchange Commission, including Synergy’s Form 10-K for
the year ended December 31, 2015. 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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