Synergy Pharmaceuticals Announces Acceptance of New Drug Application for Plecanatide, a Novel Uroguanylin Analog, in Chronic Idiopathic Constipation

NEW YORK–(BUSINESS WIRE)– Synergy Pharmaceuticals Inc. (NASDAQ:SGYP), a biopharmaceutical company
focused on the development and commercialization of novel
gastrointestinal (GI) therapies, today announced the U.S. Food and Drug
Administration (FDA) has determined that the company’s New Drug
Application (NDA) for plecanatide, its first uroguanylin analog, for the
treatment of chronic idiopathic constipation (CIC) is sufficiently
complete to permit a substantive review. The FDA Prescription Drug User
Fee Act (PDUFA) target action date is January 29, 2017.

« This is a transformative milestone for our company and reflects our
relentless commitment to bringing meaningful treatment options to
patients suffering from GI diseases,” said Gary S. Jacob, Chairman and
Chief Executive Officer of Synergy Pharmaceuticals. “If approved, we
believe plecanatide will become an important new treatment option that
will benefit patients with CIC. I want to thank the Synergy employees
and outside consultants working on the CIC NDA for their hard work and
dedication which contributed to this important milestone.”

The NDA for plecanatide is supported by two double-blind
placebo-controlled phase 3 trials and one open-label long term safety
study. A total of more than 2,700 patients with CIC received a
once-daily dose of either plecanatide or placebo across the two
placebo-controlled trials. Additionally, over 3,500 patients were
exposed to plecanatide in the CIC clinical development program.

About Plecanatide

Plecanatide is our first uroguanylin analog currently being evaluated
for use as a once-daily tablet for the treatment of two functional GI
disorders, CIC and irritable bowel syndrome with constipation (IBS-C).
Plecanatide is a 16-amino acid peptide that is structurally similar to
uroguanylin with the exception of a single amino acid change.
Plecanatide is designed to replicate the function of uroguanylin, a
naturally occurring GI peptide, by working locally in the upper GI tract
to stimulate digestive fluid movement and support regular bowel
function. In 2015, we announced positive phase 3 data with plecanatide
in two pivotal CIC clinical trials and on January 29, 2016 the company
filed its first NDA for plecanatide in CIC. We presently have two
ongoing phase 3 clinical trials with plecanatide in IBS-C and intend to
file our second NDA in IBS-C by the end of this year. We expect top-line
data results from both pivotal IBS-C trials in the third quarter of this
year.

About Synergy Pharmaceuticals Inc.

Synergy is a biopharmaceutical company focused on the development and
commercialization of novel GI therapies. Our proprietary GI platform is
based on uroguanylin and includes two lead product candidates –
plecanatide and dolcanatide. Dolcanatide is our second uroguanylin
analog currently being explored for inflammatory bowel disease.
Dolcanatide is designed to be an analog of uroguanylin with enhanced
resistance to standard digestive breakdown by proteases in the
intestine. In January 2016, we announced positive data with dolcanatide
in a phase 1b trial with ulcerative colitis patients. 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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