NEW YORK--Synergy Pharmaceuticals, Inc. (OTC BB:SGYP), a developer of new drugs to treat gastrointestinal disorders and diseases, announced today that it has completed the final tranche of its private placement in which it raised gross proceeds of an aggregate $7,092,500 million through the sale of 10,132,143 shares of common stock at a price of $0.70 per share.
The proceeds from the financing will be used to fund a Phase IIa clinical trial of Synergy’s SP-304 for chronic constipation which the Company plans to initiate in late 2009 or early 2010.
“This financing will enable Synergy to reach a critical milestone in its clinical development process, namely the completion of the Phase IIa proof-of-concept clinical trial in patients with chronic constipation, and also will provide clear potential for the drug to treat patients with constipation-predominant irritable bowel syndrome,” said Mr. Gabriele Cerrone, Chairman of Synergy. “The successful financing in this challenging environment in our opinion reflects the strong interest in SP-304 and the GC-C receptor agonist class of drugs.”
The securities issued in the private placement have not been registered under the Securities Act of 1933, as amended. Accordingly, these securities may not be offered or sold in the United States, except pursuant to the effectiveness of a registration statement or an applicable exemption from the registration requirements of the Securities Act. This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities.
About SP-304
SP-304 is a member of a new class of non-systemic drugs for treatment of chronic constipation (CC), irritable bowel syndrome with constipation (IBS-C) and other GI diseases. SP-304 is a synthetic analog of uroguanylin, a natriuretic hormone that regulates ion and fluid transport in the GI tract. Orally administered SP-304 binds to and activates guanylate cyclase C (GC-C) 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, facilitating bowel movement. In animal models, oral administration of SP-304 promotes intestinal secretion as well as ameliorating gastrointestinal inflammation.
About Chronic Constipation
Chronic constipation is a very common gastrointestinal disorder. Up to 26 million Americans suffer from the disorder, and of this population about 5 million have a severe condition necessitating relief. The prevalence of the disorder is similar in other developed countries. Patients with chronic constipation often experience hard stools, straining during bowel movements and not enough bowel movements during the week. People with chronic constipation can experience serious discomfort which adversely affects their ability to work and their quality of life.
About Irritable Bowel Syndrome
Up to one sixth of adults experience inflammatory bowel syndrome (IBS), a condition marked by disturbed bowel function and abdominal pain. IBS patients can have three different sets of symptoms; diarrhea-predominant (IBS-D), constipation-predominant (IBS-C) and mixed or alternating disorder (IBS-M). The split in prevalence between the forms is about 1/3rd each. In addition, most patients suffering from the mixed form of IBS (IBS-M) are believed to mainly have constipation. An estimated 10 million people in the US and an additional 10 million people in the EU suffer from IBS-C. IBS (all forms) accounts for 12% of adult visits to primary care physicians in the US.
About Synergy Pharmaceuticals, Inc.
Synergy is a biopharmaceutical company focused on the development of new drugs to treat gastrointestinal disorders and diseases. Synergy's proprietary drug SP-304 began clinical development in June 2008 for gastro-intestinal disorders. SP-304 recently finished a Phase I clinical trial in volunteers and the Company plans to initiate a Phase IIa clinical trial of SP-304 in chronic constipation patients in late 2009 or early 2010. SP-304 is a synthetic analog of the human gastrointestinal hormone uroguanylin, and acts by activating the guanylate cyclase C (GC-C) receptor on epithelial cells of the GI tract. More information is available at http://www.synergybio.net.
Forward-Looking Statements
Certain statements made in this press release are forward-looking. Such statements are indicated by words such as "expect," "should," "anticipate" and similar words indicating uncertainty in facts and figures. Although Synergy believes that the expectations reflected in such forward-looking statements are reasonable, it can give no assurance that such expectations reflected in such forward-looking statements will prove to be correct. As discussed in the Synergy Pharmaceuticals Annual Report on Form 10-K for the year ended December 31, 2008, and other periodic reports, as filed with the Securities and Exchange Commission, actual results could differ materially from those projected in the forward-looking statements as a result of the following factors, among others: uncertainties associated with product development, the risk that products that appeared promising in early clinical trials do not demonstrate efficacy in larger-scale clinical trials, the risk that Synergy will not obtain approval to market its products, the risks associated with dependence upon key personnel and the need for additional financing.