Synergy Pharmaceuticals Announces New Plecanatide Data Presentations at Upcoming Scientific Meeting and Provides Update on IBS-C Program

NEW YORK–(BUSINESS WIRE)– Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) today announced that the
company will present new data on plecanatide, an investigational
compound for the treatment of chronic idiopathic constipation (CIC) and
irritable bowel syndrome with constipation (IBS-C), at the American
College of Gastroenterology (ACG) annual scientific meeting at The
Venetian in Las Vegas, October 14-19, 2016.

The following two posters will be presented in Hall C on Monday, October
17th from 10:30 a.m.-4:00 p.m. PT with author presentation at the poster
from 1:00-2:15 p.m. PT:

• P1041A. Efficacy and Safety of Plecanatide in the Treatment of
  Chronic Idiopathic Constipation (CIC): Pooled Results from Two Phase 3
  Studies
  *2016 ACG
  Presidential Poster Award

— Presenter: Satish S.C. Rao, MD, PhD, Professor of Medicine, Division
Chief Fellowship Program Director, Director Digestive Health Center

• P1120. Safety and Tolerability of Plecanatide in Patients with
  Chronic Idiopathic Constipation: Long-term Evidence from an Open-Label
  Study

— Presenter: Marianela De La Portilla, MD, Genome Research Group,
Miami, FL

Plecanatide is a once-daily, orally-administered compound currently
being evaluated by the U.S. Food and Drug Administration (FDA) for the
treatment of CIC and the Prescription Drug User Fee Act (PDUFA) target
action date for plecanatide is January 29, 2017.

In addition, Synergy has already completed patient recruitment for the
two double-blind placebo-controlled phase 3 clinical trials with
plecanatide in IBS-C and remains on-track to report top-line data from
both trials in the fourth quarter of this year. Pending approval in the
CIC indication, Synergy plans to file a New Drug Application Supplement
with Clinical Data (sNDA) for plecanatide in IBS-C in the first quarter
of 2017 and expects a 10-month review period from submission.

About Chronic Idiopathic Constipation (CIC)

CIC affects 14 percent of the population in North America,
disproportionately affecting women and older adults. People with CIC
have persistent symptoms of difficult and infrequent bowel movements.
CIC can severely impact people’s daily lives, increasing stress levels
and anxiety.

About Plecanatide

Plecanatide is a peptide made up of 16 amino acids and, with the
exception of a single amino acid substitution, it is identical to
uroguanylin. Plecanatide is the first investigational drug designed to
replicate the function of uroguanylin, a naturally occurring and
endogenous human GI peptide which acts in a pH-dependent manner
targeting GC-C receptors primarily in the proximal small intestine.
Plecanatide stimulates fluid secretion and promotes stool consistency
necessary to support normal 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 around uroguanylin analogs
for the treatment of functional GI disorders and inflammatory bowel
disease. Synergy’s proprietary uroguanylin analog technology platform
includes two lead product candidates – plecanatide and dolcanatide. For
more information, please visit www.synergypharma.com.

Forward-Looking Statement

Certain statements in this press release are forward-looking within the
meaning of the Private Securities Litigation Reform Act of 1995. These
statements may be identified by the use of forward- looking words such
as « anticipate, » « planned, » « believe, » « forecast, » « estimated, »
« expected, » and « intend, » among others. These forward-looking statements
are based on Synergy’s current expectations and actual results could
differ materially. 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, 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; limited
sales and marketing efforts and dependence upon third parties; 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 Form 10-K
for the year ended December 31, 2015 and other periodic reports filed
with the Securities and Exchange Commission. 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.

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