Synergy Pharmaceuticals Appoints Paul Eng, Ph.D., as Senior Vice President, Drug Development

  Synergy Pharmaceuticals Appoints Paul Eng, Ph.D., as Senior Vice President,
  Drug Development

Business Wire

NEW YORK -- May 29, 2014

Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) today announced the appointment of
Paul Eng, Ph.D., as Senior Vice President, Drug Development. Dr. Eng will lead
all clinical development operations for Synergy’s pivotal phase 3 program with
plecanatide in patients with irritable bowel syndrome with constipation
(IBS-C).

Paul Eng, Ph.D., Senior V.P. Drug Development, Synergy Pharmaceuticals Inc.
(Photo: Business Wire)

Paul Eng, Ph.D., Senior V.P. Drug Development, Synergy Pharmaceuticals Inc.
(Photo: Business Wire)

“Dr. Paul Eng brings a considerable amount of recent experience and valuable
expertise, having successfully led late-stage clinical programs through NDA
and drug approval for chronic idiopathic constipation (CIC) and IBS-C,” said
Gary S. Jacob, Ph.D., Chairman and CEO of Synergy Pharmaceuticals. “We are
fortunate to have Paul join us and look forward to his contributions as we
quickly advance plecanatide into phase 3 registration trials for IBS-C and
prepare for a CIC NDA filing next year.”

“I am excited to be joining Synergy at such a critical stage of development,”
said Dr. Eng. “Plecanatide has already demonstrated excellent clinical
potential for treating IBS-C and CIC patients in phase 2 trials and I look
forward to further establishing plecanatide’s efficacy and safety profile in
pivotal phase 3 trials.”

Prior to joining Synergy, Dr. Eng was Director of Gastroenterology Clinical
Development at Forest Laboratories, Inc., where he was chiefly responsible as
study director for the successful pivotal phase 3 clinical trials that led to
NDA and drug approval for treatment of CIC and IBS-C. Dr. Eng has a
considerable record of achievement in clinical development and medical
affairs, with positions at American Home Products (Wyeth) and Life Medical
Sciences prior to joining Forest Laboratories in 2001. Dr. Eng holds a Ph.D.,
Immunology, M.S., Human Genetics and B.S., Physiology from Rutgers University.

About Plecanatide

Plecanatide is Synergy’s lead uroguanylin analog in late-stage clinical
development to treat patients with CIC and IBS-C. Uroguanylin is a natural
gastrointestinal (GI) hormone produced by humans in the small intestine and
plays a key role in regulating the normal functioning of the digestive tract
through its activity on the guanylate cyclase-C (GC-C) receptor. The GC-C
receptor is known to be a primary source for stimulating a variety of
beneficial physiological responses. Orally administered plecanatide mimics
uroguanylin's functions by binding to and activating the GC-C receptor to
stimulate fluid and ion transit required for normal bowel function.
Plecanatide is structured identical to the natural hormone with one key amino
acid substitution, resulting in a more potent and heat-stable analog and a
binding constant eight times that of uroguanylin. Synergy has successfully
completed a phase 2b trial of plecanatide in 951 patients with CIC and is
currently enrolling patients in two pivotal phase 3 CIC trials. The company
also recently announced positive top-line data results from a phase 2b
dose-ranging study with plecanatide in patients with IBS-C.

About Synergy Pharmaceuticals

Synergy Pharmaceuticals (NASDAQ: SGYP) is a biopharmaceutical company focused
on the development of novel therapies based on the natural human hormone,
uroguanylin, to treat GI diseases and disorders. Synergy has created two
unique analogs of uroguanylin – plecanatide and SP-333 – designed to mimic the
natural hormone’s activity on the GC-C receptor and target a variety of GI
conditions. SP-333 is currently in phase 2 development for opioid-induced
constipation and is also being explored for ulcerative colitis. 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, 2013 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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Contact:

Company:
Synergy Pharmaceuticals Inc.
Gem Gokmen, 212-584-7610
ggokmen@synergypharma.com
 
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