Synergy Pharmaceuticals Presents New In Vitro Data Showing the pH-Dependent Activity of Plecanatide Replicates That of Naturally Occurring GI Peptide Uroguanylin

NEW YORK–(BUSINESS WIRE)– Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) today presented new in vitro
data at Digestive Disease Week (DDW) showing plecanatide, an
investigational compound being evaluated for chronic idiopathic
constipation (CIC) and irritable bowel syndrome with constipation
(IBS-C), replicated the pH-dependent activity of the body’s naturally
occurring gastrointestinal (GI) peptide – uroguanylin. Uroguanylin plays
an important role in supporting regular bowel function through its
activation of the intestinal guanylate cyclase C (GC-C) receptor.

In vitro data presented today at DDW show that plecanatide, like
uroguanylin, activates the GC-C receptor in a pH-dependent manner, and
this may contribute to more frequent, well-formed bowel movements. While
the under-secretion of fluid can cause constipation, the over-secretion
of fluid can result in diarrhea. The balance of fluid secretion in the
gut is normally achieved by a controlled – and pH-dependent – activation
of the GC-C receptor by uroguanylin.

“A need still exists for additional safe and convenient therapeutic
options,” said Kunwar Shailubhai, PhD, MBA, Chief Scientific Officer of
Synergy Pharmaceuticals. “We designed plecanatide to act in the same
pH-dependent manner as uroguanylin because we believe that this
characteristic is an important natural attribute for controlling fluid
balance in the gut and promoting regular bowel function.”

Earlier this week at DDW, Synergy presented phase 3 clinical data from
two trials that evaluated the efficacy and safety of plecanatide
treatment in patients with CIC. In both trials, plecanatide
significantly improved chronic constipation and abdominal symptoms, such
as straining and bloating, and plecanatide-treated patients showed
significant improvement in stool consistency, constipation severity and
treatment satisfaction scores compared to placebo. Most adverse events
were mild to moderate in severity; the most common adverse event was
diarrhea (5.9% in 3 mg and 5.7% in 6 mg dose groups compared to 1.3% in
the placebo group for Study-00 and 3.2% in 3 mg and 4.5% in 6 mg dose
groups compared to 1.3% in the placebo group in Study-03).

About Chronic Idiopathic Constipation (CIC)

CIC affects 14 percent of the population in North America,
disproportionately impacting 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 currently being evaluated for use as a once-daily tablet
for two functional gastrointestinal (GI) disorders, CIC and irritable
bowel syndrome with constipation (IBS-C). Plecanatide is a peptide made
up of 16 amino acids. It is structurally similar to uroguanylin with the
exception of a single amino acid change. Plecanatide is the first
investigational drug designed to replicate the function of uroguanylin,
a naturally occurring human GI peptide, by working locally in the upper
GI tract to stimulate digestive fluid movement and support regular bowel
function. In 2015, Synergy announced positive phase 3 data with
plecanatide in two pivotal CIC clinical trials and on January 29, 2016,
the company submitted its first new drug application (NDA) for
plecanatide in CIC. If approved, Synergy plans to launch plecanatide
with the CIC indication in the first quarter of 2017. Synergy presently
has two ongoing phase 3 clinical trials with plecanatide in IBS-C and
intends to file a second NDA in IBS-C by the end of this year.

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 GI platform is based on uroguanylin and
includes two lead product candidates – plecanatide and dolcanatide. For
more information, please visit www.synergypharma.com.

Forward-Looking Statements

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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