Synergy Pharmaceuticals 

22.10.2012 23:00
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Scientific Poster Presentation This Week at ACG 2012

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 a presentation on
SP-333, the company's second investigational drug from the guanylate cyclase-C
agonist class, at the American College of Gastroenterology 77th annual meeting,
which is being held in Las Vegas, NV from October 19-24, 2012. The presentation
highlights pioneering research demonstrating that SP-333 ameliorates colitis in
mice through inhibition of NF-kappa B activation. SP-333 recently entered
clinical trials as an experimental drug for the treatment of ulcerative
colitis, and is presently in a Phase I trial in healthy volunteers. 

The poster presentation is on Sunday October 21, 2012 from 3:30-7:00PM in
Exhibit Hall B at The Venetian. 

Poster Title:SP-333, a Proteolysis-resistant Agonist of Guanylate Cyclase-C,
Inhibits Activation of NF-?B and Suppresses Production of Inflammatory
Cytokines to Ameliorate DSS-induced Colitis in Mice (P414), authored by Graham
Zhang, Krishna P. Arjunan, John A. Foss, Stephen J. Comiskey and Kunwar
Shailubhai. 

'SP-333 is a highly potent oral drug candidate for treatment of GI inflammatory
diseases,' stated Dr. Gary S. Jacob, President and CEO of Synergy
Pharmaceuticals. 'SP-333 broadens our clinical portfolio of novel GC-C agonists
for treatment of GI disorders and diseases.' 

'The transcription factor NF-?appa B is known to be abnormally active in many
inflammatory diseases and cancers,' said Dr. Kunwar Shailubhai, Chief
Scientific Officer of Synergy Pharmaceuticals. 'The study we report here,
demonstrating that treatment with SP-333 inhibits activation of NF-kappa B, is
an exciting scientific finding that opens a new avenue for treatment of
ulcerative colitis. Oral treatment with SP-333, a first-in-class guanylate
cyclase-C (GC-C) agonist to treat ulcerative colitis, showed impressive
anti-inflammatory activity in experimental models of colitis in mice.' 

About SP-333

SP-333 is a synthetic analog of uroguanylin, a natriuretic hormone which is
normally produced in the body's intestinal tract. Deficiency of uroguanylin is
likely to be one of the primary reasons associated with formation of polyps as
well as debilitating and difficult-to-treat GI inflammatory disorders such as
ulcerative colitis and Crohn's disease. Orally-administered SP-333 binds to and
activates guanylate cyclase C (GC-C) expressed on epithelial cells lining the
GI mucosa, resulting in stimulation of cyclic GMP in target tissues. SP-333 has
been found to be highly stable against proteolysis in simulated intestinal
fluid for up to 24 hours. Its enhanced stability makes this peptide an
extremely potent GC-C agonist in animal studies in mice and monkeys, promoting
bowel movement in monkeys, and ameliorating GI inflammation in mice,
respectively. 

About Plecanatide

Plecanatide is a member of a new class of essentially non-systemic drugs,
referred to as guanylate cyclase C (GC-C) agonists, which 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. 

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
constipation-predominant irritable bowel syndrome (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. 

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
         
         Investor Contact:
         Danielle Spangler
         The Trout Group
         synergy@troutgroup.com
         (646) 378-2924
News Source: NASDAQ OMX



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Language:     English
Company:      Synergy Pharmaceuticals
              
               
              United States
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ISIN:         US8716393082
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