Synergy Pharmaceuticals Acquires FV-100 Shingles Drug From Bristol-Myers Squibb Company
August 24th, 2012 // 11:13 pm @ marquee
Synergy Pharmaceuticals Inc. (Nasdaq:SGYP), a developer of new drugs to treat gastrointestinal disorders and diseases, today announced that it has signed an Asset Purchase Agreement with Bristol-Myers Squibb Company (NYSE:BMY) and has acquired the assets related to FV-100, an orally available nucleoside analogue, currently being developed for the treatment of shingles, a severe, painful skin rash caused by reactivation of the varicella zoster virus – the virus that causes chickenpox.
“FV-100 is a drug candidate we believe has great potential to treat patients suffering from shingles,” said Dr. Gary S. Jacob, CEO of Synergy Pharmaceuticals. “We believe that with our expanding clinical experience in utilizing patient-reported outcome tools from our GI program, a feature that will be necessary for supporting pain-related indications for FV-100, we are in a unique position to further develop FV-100 for patients not adequately treated with present-day therapy.”
FV-100 earlier completed a Phase 2a clinical trial in shingles patients, in which the drug was given to a total of 230 patients comprised of two cohorts of 115 patients dosed at 200 mg and 400 mg, respectively, and found to be well tolerated at both doses. Clinically meaningful reductions in time to resolution of clinically significant pain and in incidence of post-herpetic neuralgia were noted.
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 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 CIC patients. In October, 2011, Synergy initiated dosing of patients in a major 880-patient Phase II/III clinical trial of plecanatide to treat chronic idiopathic constipation. Plecanatide is also being developed to treat constipation-predominant irritable bowel syndrome, with the first trial in IBS-C patients planned for the second half of 2012. Synergy’s second GC-C agonist SP-333 is currently in pre-clinical development to treat inflammatory bowel diseases. More information is available at http://www.synergypharma.com.
