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Synergy Pharmaceuticals Announces Positive End-of-Phase 2 Meeting with FDA for Plecanatide in Chronic Idiopathic Constipation

  Synergy Pharmaceuticals Announces Positive End-of-Phase 2 Meeting with FDA
  for Plecanatide in Chronic Idiopathic Constipation

    Phase 3 Pivotal Program to be Initiated in the Fourth Quarter of 2013

Business Wire

NEW YORK -- August 5, 2013

Synergy Pharmaceuticals Inc. (Nasdaq: SGYP) today announced that it has
completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration
(FDA) on Synergy’s drug plecanatide for the treatment of chronic idiopathic
constipation (CIC). At that meeting, agreement was reached on the clinical
development plan. A pivotal phase 3 program evaluating the safety and efficacy
of plecanatide in CIC patients will be initiated in the fourth quarter of
2013.

Agreement was reached with the FDA on design, duration, size and primary and
secondary efficacy endpoints for the pivotal phase 3 studies.

"We are very pleased with the outcome of our end-of-phase 2 meeting with the
FDA where clear guidance was provided on clinical safety and efficacy
requirements for completion of a registration program for plecanatide in CIC,"
said Dr. Gary S. Jacob, President and CEO of Synergy. "A great deal of effort
and planning have gone into preparations for our phase 3 development program,
and we are now focused on the initiation of pivotal studies in the fourth
quarter of this year."

About Plecanatide

Plecanatide is Synergy’s lead guanylate cyclase-C (“GC-C”) agonist in
development to treat patients with the functional GI disorders of chronic
idiopathic constipation (CIC) and irritable bowel syndrome with constipation
(IBS-C). Plecanatide is a proprietary synthetic analog of uroguanylin, a
hormone the body naturally produces to regulate critical GI functions. Orally
administered plecanatide, like uroguanylin, binds to and activates the GC-C
receptor expressed in the GI tract, resulting in fluid secretion and
normalization of bowel movement.

About Synergy Pharmaceuticals, Inc.

Synergy Pharmaceuticals Inc. is a biopharmaceutical company focused on the
development of new drugs to treat patients with gastrointestinal (GI) diseases
and disorders. Synergy’s lead drug, plecanatide, and next generation
candidate, SP-333, are proprietary analogs of the natural human GI hormone,
uroguanylin, and members of the new class of guanylate cyclase-C (“GC-C”)
agonists. Plecanatide is currently in development for the treatment of chronic
idiopathic constipation (CIC) and irritable bowel syndrome with constipation
(IBS-C). Synergy is currently enrolling IBS-C patients for its Phase 2b
clinical trial. SP-333 is in development to treat patients with inflammatory
bowel disease and other GI conditions. More information is available at
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, 2012 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.

Contact:

Synergy Pharmaceuticals Inc.
Media
Gem Gokmen, 212-584-7610
Mobile: 646-637-3208
ggokmen@synergypharma.com
or
Investors
Bernard Denoyer, 212-297-0020
Mobile: 203-300-8147
bdenoyer@synergypharma.com
 
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