Synergy Pharmaceuticals Provides Update on Ongoing FDA Review of Plecanatide CIC NDA and IBS-C Clinical Development Program

NEW YORK–(BUSINESS WIRE)–Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) today announced it has
reached the Food and Drug Administration (FDA) mid-cycle review
milestone for the plecanatide new drug application (NDA) in chronic
idiopathic constipation (CIC). Additionally, the company is providing an
update on the ongoing irritable bowel syndrome with constipation (IBS-C)
program.
“We are pleased with the progress and ongoing dialogue with the FDA,”
said Gary S. Jacob, Chairman and CEO of Synergy Pharmaceuticals, “We
remain optimistic about the potential approval of plecanatide in CIC by
the PDUFA date of January 29, 2017. I am also very pleased with the
progress our commercial, medical affairs and supply chain teams have
made in recent months as we anticipate bringing this important new
treatment option to CIC patients and their caregivers early next year.”
Furthermore, the company has decided to continue patient enrollment for
its two ongoing phase 3 clinical trials with plecanatide in IBS-C. The
decision to continue enrollment comes after trial monitoring
demonstrated a slower enrollment pace combined with an increase in the
number of patients not meeting randomization criteria after the
screening period prior to starting treatment.
“Our first priority is to ensure high quality trials that reflect our
rigorous standards and expectations,” said Dr. Jacob, “To that end, we
are updating our timing for top-line data in both trials to the fourth
quarter of this year and intend to file the plecanatide NDA in IBS-C in
the first quarter of 2017. We remain confident that plecanatide will
continue to deliver outstanding clinical results consistent with
previous trials, ultimately providing an important treatment option for
patients suffering from IBS-C.”
About Plecanatide
Plecanatide is currently being evaluated for use as a once-daily tablet
for two functional gastrointestinal (GI) disorders, CIC and 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.
About Synergy Pharmaceuticals
Synergy Pharmaceuticals 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.