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Prospectus SYNERGY PHARMACEUTICALS, - 12-28-2012

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Prospectus SYNERGY PHARMACEUTICALS,  - 12-28-2012 Powered By Docstoc
					                                   UNITED STATES
                       SECURITIES AND EXCHANGE COMMISSION
                                                            Washington, DC 20549


                                                             FORM 8-K
                                                          CURRENT REPORT

                           Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

                                      Date of Report (Date of earliest event reported): December 28, 2012


                                            Synergy Pharmaceuticals Inc.
                                              (Exact name of registrant as specified in its charter)

                  Delaware                                         001-35268                                        33-0505269
          (State or other jurisdiction                            (Commission                                      IRS Employer
      of incorporation or organization)                           File Number)                                   Identification No.)

                                                      420 Lexington Avenue, Suite 1609
                                                            New York, NY 10170
                                                    (Address of principal executive offices)

                                      Registrant’s telephone number, including area code: (212) 297-0020


                                          (Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of
the following provisions:

      Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

      Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

      Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

      Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 8.01                Other Events.

         On December 28, 2012, Synergy Pharmaceuticals Inc. (the “Company”) issued a press release announcing the successful completion
of a Phase I single-ascending-dose clinical trial of SP-333, a guanylate cyclase C (GC-C) agonist designed to treat ulcerative colitis (UC) and
other GI diseases. A copy of the Company’s press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

        The information disclosed under this Item 8.01, including Exhibit 99.1 hereto, is being furnished and shall not be deemed “filed” for
purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be incorporated by reference into any registration
statement or other document pursuant to the Securities Act of 1933, as amended, except as expressly set forth in such filing.

Additional Information and Where to Find It

This communication does not constitute an offer to buy, or solicitation of an offer to sell, any securities of Synergy Pharmaceuticals Inc. (the
“Company”), and no offer or sale of such securities will be made in any jurisdiction where it would be unlawful to do so. In connection with
the merger with Callisto Pharmaceuticals, Inc. (“Callisto”), the Company has filed with the SEC a registration statement on Form S-4 that
includes a proxy statement and prospectus of the Company relating to the merger. INVESTORS AND SECURITY HOLDERS ARE URGED
TO READ THE REGISTRATION STATEMENT AND PROXY STATEMENT/PROSPECTUS, AND ANY OTHER RELEVANT
DOCUMENTS, WHEN THEY BECOME AVAILABLE, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT
SYNERGY, CALLISTO AND THE MERGER. Investors and security holders will be able to obtain these materials (when they are available)
and other documents filed with the SEC free of charge at the SEC’s website, www.sec.gov. In addition, copies of the registration statement and
proxy statement/prospectus may be obtained free of charge by accessing the Company’s website at www.synergypharma.com or upon written
request to the Company at Synergy Pharmaceuticals Inc., 420 Lexington Avenue, Suite 1609, New York, New York 10170, Attention: Investor
Relations. Stockholders may also read and copy any reports, statements and other information filed by the Company with the SEC, at the SEC
public reference room at 100 F Street, N.E., Washington D.C. 20549. Please call the SEC at 1-800-SEC-0330 or visit the SEC’s website for
further information on its public reference room.

Participants in the Solicitation

The Company and Callisto and their respective directors, executive officers and employees may be deemed to be participants in the solicitation
of proxies from the stockholders of the Company and Callisto in connection with the proposed merger transaction. Information regarding the
special interests of these directors and executive officers in the merger transaction have been included in the proxy statement/prospectus
referred to above. Additional information regarding the directors and executive officers of the Company is also included in the Company’s
Annual Report on Form 10-K for year ended December 31, 2011. This document is available free of charge at the SEC’s web site
(www.sec.gov) and from Investor Relations at the Company at the

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address set forth above. Additional information regarding the directors and executive officers of Callisto is also included in Callisto’s Annual
Report on Form 10-K, for the year ended December 31, 2011. This document is available free of charge at the SEC’s web site (www.sec.gov)
and from Investor Relations at Callisto upon written request at Callisto Pharmaceuticals, Inc., 420 Lexington Avenue, Suite 1609, New York,
New York 10170, Attention: Investor Relations.

Item 9.01.               Financial Statements and Exhibits.

         (d)    Exhibits.

                  99.1        Synergy Pharmaceuticals, Inc. Press Release, dated December 28, 2012.

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                                                                 SIGNATURE

         Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its
behalf by the undersigned hereunto duly authorized.

Dated: December 28, 2012


                                                                         SYNERGY PHARMACEUTICALS INC.


                                                                         By:   /s/ Gary S. Jacob
                                                                               Gary S. Jacob, Ph.D.
                                                                               President and Chief Executive Officer

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                                                                                                                                      Exhibit 99.1

Synergy Pharmaceuticals Completes Phase I Trial of SP-333, a Second-Generation GC-C Agonist to Treat Gastrointestinal Diseases

NEW YORK, Dec. 28, 2012 (GLOBE NEWSWIRE) — Synergy Pharmaceuticals Inc. (SGYP), a developer of new drugs to treat
gastrointestinal (GI) disorders and diseases, announced today the successful completion of a Phase I single-ascending-dose clinical trial of
SP-333, a guanylate cyclase C (GC-C) agonist designed to treat ulcerative colitis (UC) and other GI diseases. SP-333 has exhibited potent
anti-inflammatory activity in animal studies of colitis, displaying a novel mechanism-of-action that the Company believes can provide a new
way to treat UC patients with mild to moderate disease.

This study was designed as a placebo-controlled, dose-escalating, single-dose trial in healthy adult volunteers, primarily focused on exploring
the safety profile of SP-333. Eight cohorts were dosed, ranging from 0.1 to 60 mg of SP-333. There were no serious or unexpected adverse
events in this study. Importantly, SP-333 exhibited gastrointestinal pharmacodynamic characteristics that were anticipated based on its GC-C
receptor agonist activity. A multi-dose, dose-escalation trial in volunteers is planned to start in January.

“We specifically designed SP-333 to have superior stability against proteolytic degradation which normally occurs in intestinal fluid designed
to break down proteins and peptides as part of the normal digestive process,” said Dr. Kunwar Shailubhai, Chief Scientific Officer of Synergy
Pharmaceuticals. “SP-333, to our knowledge, represents the most proteolytically stable analog of uroguanylin - the physiological agonist of
GC-C - ever developed, and is designed to remain biologically active in the gut, a factor we consider ideal for its potential use in treating UC.”

About SP-333

SP-333 is a synthetic analog of uroguanylin, a natriuretic peptide hormone which is normally produced in the lumen of the 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
the GC-C receptor 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. SP-333 has been found to exhibit potent anti-inflammatory activity in several animal models of
experimental colitis, through a mechanism-of-action involving inhibition of NF-kB to suppress production of pro-inflammatory cytokines.

About Ulcerative Colitis

More than 500,000 Americans are afflicted with ulcerative colitis (UC), a type of Inflammatory Bowel Disease (IBD) that causes chronic
inflammation of the colon. Along with Crohn’s disease, the other major form of IBD, ulcerative colitis is painful and debilitating. Patients with
UC are at
increased risk for colon cancer and may ultimately require surgical removal of the colon. There is currently no medical cure for ulcerative
colitis. Long-term remission with current treatments is limited. Therefore, there is a need for new treatment approaches to treat patients with
ulcerative colitis.

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, a Phase IIa clinical trial in chronic idiopathic constipation (CIC) patients and has just completed a major Phase II/III clinical trial of
plecanatide to treat CIC. Top-line results are expected to be released the first week of January 2013. Synergy intends to have an end of Phase II
CIC meeting with the FDA in the first half of 2013. Synergy’s second GC-C agonist, SP-333, is currently in a Phase I clinical trial in
volunteers. The development program for SP-333 is for treatment of inflammatory bowel diseases. 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

				
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