Synergy Pharmaceuticals Announces Issuance of Three New Patents Expected to Extend TRULANCE™ (Plecanatide) Patent Protection Until 2032

NEW YORK–(BUSINESS WIRE)– Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) today announced that the
United States Patent and Trademark Office (USPTO) has issued three new
patents covering TRULANCE (plecanatide). The first patent relates to the
method for manufacturing TRULANCE and will expire March 1, 2032. The two
other patents relate to formulations and methods of using TRULANCE for
treating chronic idiopathic constipation (CIC) and irritable bowel
syndrome with constipation (IBS-C) at 3mg or 6 mg dose; both of these
patents will expire September 15, 2031.

“We are very pleased these additional patents were allowed and issued as
they are a significant addition to the TRULANCE patent portfolio,
providing extended exclusivity protection for TRULANCE”, said Dr. Gary
S. Jacob, Chairman and Chief Executive Officer of Synergy
Pharmaceuticals Inc. “This marks an important step in our ongoing
efforts to optimize the value of TRULANCE.”

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
company began marketing TRULANCE in the U.S. for adults with CIC on
March 20, 2017. The recommended dosage of TRULANCE is 3 mg taken orally,
once daily, with or without food at any time of the day.

On March 24, 2017, the company submitted a supplemental New Drug
Application (sNDA) for TRULANCE for the treatment of adults with IBS-C.

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% than in the
  placebo group) was diarrhea (5% vs 1% placebo).

Please click here for
Full Prescribing Information.

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 Inc.

Synergy is a biopharmaceutical company focused on the development and
commercialization of novel gastrointestinal (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™ (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, 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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