Synergy Pharmaceuticals 

22.10.2012 23:00
---------------------------------------------------------------------------

Scientific Poster Presentations This Week at ACG 2012 and UEG Week

NEW YORK, 2012-10-22 23:00 CEST (GLOBE NEWSWIRE) --
Synergy Pharmaceuticals Inc. (Nasdaq:SGYP), a developer of new drugs to treat
gastrointestinal disorders and diseases, today announced the preclinical
findings being presented by Synergy scientists at two key gastroenterology
congresses this week. 

The scientific poster presentations describe the site of action and other
mechanistic features of plecanatide, Synergy's investigational drug for the
treatment of chronic idiopathic constipation (CIC) and irritable bowel syndrome
with constipation (IBS-C). Plecanatide is an agonist of the guanylate cyclase-C
receptor and an analog of the natriuretic peptide, uroguanylin, the physiologic
ligand of GC-C. As a uroguanylin analog, plecanatide is a member of a new class
of non-systemic oral drugs, known as guanylate cyclase-C (GC-C) agonists, that
act locally to promote intestinal fluid secretion. 

'These preclinical studies helped to define plecanatide as a superior candidate
for clinical testing in patients with chronic constipation,' said Dr. Kunwar
Shailubhai, Chief Scientific Officer of Synergy Pharmaceuticals, who is
presenting the data at the America College of Gastroenterology annual meeting
in Las Vegas, NV this week. 

'In phase I and early phase II clinical testing, plecanatide exhibited an
excellent safety profile, and patients in the phase IIa trial experienced
relief from constipation without any remarkable diarrhea,' said Stephen
Comiskey, Synergy's Vice President for Product Development, who is presenting
the preclinical data at the 20th United European Gastroenterology Week in
Amsterdam, The Netherlands this week. 'This summer Synergy achieved target
enrollment in an ongoing phase IIb/III clinical trial of plecanatide in
patients with chronic constipation, and we look forward to the results later
this year.' 

Key preclinical findings being presented that informed the clinical testing of
plecanatide as an optimal drug candidate include: 

  -- Orally administered plecanatide acts primarily in the proximal intestine to
     stimulate water secretion essential for normalizing bowel movement.
  -- In vitro binding studies demonstrate that plecanatide binds to the same
     receptors in the proximal intestine as human uroguanylin.
  -- Plecanatide is highly stable and potent, with even greater affinity for the
     human GC-C receptors than the natural uroguanylin hormone.

'There is a compelling need to find safe and effective treatments for patients
with CIC,' said Douglas Drossman, Adjunct Professor of Medicine and Psychiatry
and Co-Director Emeritus, UNC Center for Functional GI and Motility Disorders,
UNC School of Medicine. 'I am encouraged by the preclinical and early phase
clinical data that demonstrate proof of concept for plecanatide as a treatment
approach for chronic constipation, and look forward to seeing data from the
ongoing trials.' 

Earlier this fall, in a poster session at the Joint International
Neurogastroenterology and Motility Meeting, September 6-8, in Bologna, Italy,
Synergy scientists also shared data describing the identification and selection
of plecanatide (formerly SP-304) as a superior analog of uroguanylin based on
physiochemical properties. 

Posters Cited

AMERICAN COLLEGE OF GASTROENTEROLOGY ANNUAL MEETING

October 19-24, 2012, Las Vegas, NV

Orally Administered Plecanatide, A Guanylate Cyclase-C Agonist, Acts in the
Lumen of the Proximal Intestine to Facilitate Normal Bowel Movement in Mice and
Monkeys. (P451) Authored by Stephen Comiskey, John Foss, Gary Jacob, and Kunwar
Shailubhai. 

UNITED EUROPEAN GASTROENTEROLOGY WEEK

October 20-24, 2012, Amsterdam, The Netherlands

Orally Administered Plecanatide, A Guanylate Cyclase-C Agonist, Acts in the
Proximal Intestine to Stimulate Fluid Secretion to Normalize Bowel Movement.
(P1003) 

Authored by Stephen Comiskey, John Foss and Kunwar Shailubhai.

JOINT INTERNATIONAL EUROGASTROENTEROLOGY AND MOTILITY MEETING

September 6-8, 2012, Bologna, Italy

Plecanatide, a Superior Analog of Uroguanylin, as an Oral Drug Candidate for
Treatment of Gastrointestinal Functional Disorders and Diseases. (P330) 

Authored by Andrea Brancale, Gary Jacob and Kunwar Shailubhai.

About Synergy Pharmaceuticals Inc.

Synergy is a biopharmaceutical company focused on the development of new drugs
to treat gastrointestinal disorders and diseases. Synergy's lead proprietary
drug candidate plecanatide is a synthetic analog of the human gastrointestinal
(GI) hormone uroguanylin, and functions by activating the guanylate cyclase C
receptor on epithelial cells of the GI tract. Synergy completed a Phase I study
of plecanatide in healthy volunteers and a Phase IIa clinical trial in chronic
idiopathic constipation (CIC) patients. In October, 2011, Synergy initiated
dosing of patients in a major Phase II/III clinical trial of plecanatide to
treat CIC. Plecanatide is also being developed to treat irritable bowel
syndrome with constipation (IBS-C), with the first trial in IBS-C patients
planned for the second half of 2012. Synergy's second GC-C agonist SP-333 is in
clinical development to treat inflammatory bowel diseases, and is presently in
a Phase I trial in healthy volunteers. More information is available at
http://www.synergypharma.com . 

About Plecanatide

Plecanatide is a member of a new class of essentially non-systemic drugs,
referred to as guanylate cyclase C (GC-C) agonists, that are currently in
development to treat CIC and IBS-C. Plecanatide is a synthetic analog of
uroguanylin, a natriuretic hormone that regulates ion and fluid transport in
the GI tract. Orally-administered plecanatide binds to and activates GC-C
receptors expressed on epithelial cells lining the GI mucosa, resulting in
activation of the cystic fibrosis transmembrane conductance regulator (CFTR),
and leading to augmented flow of chloride and water into the lumen of the gut.
Activation of the GC-C receptor pathway is believed to facilitate bowel
movement as well as producing other beneficial physiological responses
including improvement in abdominal pain and inflammation. In animal models,
oral administration of plecanatide promotes intestinal secretion and also
ameliorates GI inflammation. 

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,
2011 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: Media Contact:  Janet Skidmore
         Office:  215-658-4915
         Mobile:  215-429-2917
         skidmorecomm@earthlink.net
News Source: NASDAQ OMX



22.10.2012 Dissemination of a Corporate News, transmitted by DGAP - 
a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.

DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de

---------------------------------------------------------------------------
 
Language:     English
Company:      Synergy Pharmaceuticals
              
               
              United States
Phone:        
Fax:          
E-mail:       
Internet:     
ISIN:         US8716393082
WKN:          
 
End of Announcement                             DGAP News-Service
 
---------------------------------------------------------------------------