NEW YORK--Synergy Pharmaceuticals, Inc. (OTCQB:SGYP.OB), a developer of new drugs to treat gastrointestinal (GI) disorders and diseases, announced today the appointment of Laura Barrow, Pharm. D. as Vice President, Clinical Operations. In this newly created position, Dr. Barrow will report to President and Chief Executive Officer Gary S. Jacob, Ph.D. and will be responsible for guiding Synergy's clinical programs, including the Phase II/III study for plecanatide, the Company's lead drug candidate.
“Laura is a tremendous asset to our management team, and I am very pleased to welcome her to Synergy,” said Dr. Jacob. “Laura has extensive experience in clinical operations and project management in the pharmaceutical industry, across a variety of therapeutic areas including the gastrointestinal (GI) space. In addition, she has considerable knowledge about regulatory compliance, and working with CROs to improve overall business practices.”
Dr. Barrow has more than 25 years of experience in the pharmaceutical industry, having spent seven years in clinical research at Hoffmann–La Roche; 17 years in project management and organizational effectiveness at Bristol-Myers Squibb and was most recently Worldwide Head of Clinical and Regulatory Standard Operating Procedures at Pfizer. She has managed and led project teams that launched successful products in infectious disease and was executive director and coordinator for the exploratory development operating committee at Bristol-Myers for more than 10 years.
“Synergy has an innovative and exciting technology platform that offers great potential for the treatment of GI disorders and diseases,” said Dr. Barrow. “I believe my experience and track record in clinical development will be helpful, particularly with respect to Synergy’s lead drug candidate, plecanatide, which is scheduled to enter a Phase II/III trial later this year to treat chronic constipation.”
About Plecanatide
Plecanatide is a member of a new class of non-systemic drugs for treatment of CC, constipation-predominant-irritable bowel syndrome (IBS-C) and other functional GI disorders. 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 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 plecanatide promotes intestinal secretion as well as ameliorating gastrointestinal inflammation.
About Chronic Idiopathic Constipation (CIC)
CIC 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 intervention. The prevalence of the disorder is similar in other developed countries. Patients with CIC often experience hard stools, straining during bowel movements and not enough bowel movements during the week. People with CIC can experience serious discomfort which adversely affects their ability to work and their quality of life.
About Irritable Bowel Syndrome (IBS)
Up to one sixth of adults experience irritable 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 candidate plecanatide is a synthetic analog of the human gastrointestinal hormone uroguanylin, and functions by activating the guanylate cyclase C (GC-C) receptor on epithelial cells of the GI tract. Plecanatide has recently completed a Phase IIa clinical trial in patients to treat CC. The Company plans to initiate a Phase II/III 90-day repeated-oral-dose, placebo-controlled clinical trial of plecanatide in CC patients in the second half of 2011. Plecanatide is also being developed to treat IBS-C, with the first trial in IBS-C patients planned for 2012. More information is available at http://www.synergypharma.com.
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," "believe," "forecast," "estimated" and "intend," among others. These forward-looking statements, including Synergy’s plan to initiate a Phase II/III 90-day repeated-oral-dose, placebo-controlled clinical trial of plecanatide in CC patients in the second half of 2011, 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. Synergy does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Synergy's Form 10-K for the year ended December 31, 2010 and periodic reports filed with the Securities and Exchange Commission.