USPTO issues patent to Synergy's SP-333 for treatment of IBD

Synergy Pharmaceuticals, Inc. (OTCBB: SGYP), a developer of new drugs to treat gastrointestinal (GI) disorders and diseases, announced today that on February 1, 2011 the U.S. Patent and Trademark Office issued U.S. Patent No. 7,879,802, covering Synergy's novel drug candidate SP-333 to treat inflammatory bowel disease (IBD). SP-333 is a second-generation guanylate cyclase C (GC-C) agonist with the potential to treat gastro-intestinal diseases such as ulcerative colitis. The patent entitled "Agonists of Guanylate Cyclase Useful for the Treatment of Gastrointestinal Disorders, Inflammation, Cancer and Other Disorders" specifically claims composition of matter of SP-333 and use in the treatment of human diseases.

"SP-333, to our knowledge, represents the most potent and stable GC-C agonist ever developed," stated Dr. Gary S. Jacob, President and CEO of Synergy Pharmaceuticals. "This issued patent covering SP-333's composition of matter is a key addition to our intellectual property estate, providing the framework for our plans to pursue GC-C agonists to treat inflammatory bowel diseases such as ulcerative colitis."

"The science behind SP-333 marks a new approach to the treatment of gastrointestinal anti-inflammatory diseases," said Dr. Kunwar Shailubhai, Chief Scientific Officer of Synergy Pharmaceuticals, and senior inventor of SP-333. "In animal studies of GI inflammation, SP-333 at an oral dose as low as 0.05 mg/kg body weight demonstrated superior anti-inflammatory activity compared to 5-aminosalicylic acid (5-ASA) given at a dose of 100 mg/kg. We are excited with SP-333's impressive anti-inflammatory activity, and are pleased to be the first to patent a drug in this next-generation category of potential therapies for GI inflammatory diseases."

Synergy plans to file an Investigational New Drug (IND) application of this innovative therapy in 2011, and plans to initiate a Phase I trial of SP-333 in healthy volunteers before the end of the year. SP-333 will be the second drug from Synergy's portfolio of GC-C agonists to enter the clinic.