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Phase IIIb Clinical Data Validate the Overall and Cardiovascular,Safety Profile of Cycloset (A Quick Release Formulation of,Bromocriptine Mesylate) in Patients with Type 2 Diabetes

Data Also Support Drug's Efficacy at Improving Glycemic Control and Reducing Diabetic Cardiovascular Complications

CHICAGO, Ill., June 23, 2007 /PRNewswire/ -- VeroScience, LLC, in conjunction with its commercialization partner S2 Therapeutics, Inc., reported today the results of its Phase IIIb clinical trial supporting the overall and cardiovascular safety of Cycloset(TM) (A quick release formulation of bromocriptine mesylate) in subjects with type 2 diabetes. The study, which highlighted a significant reduction in the risk of diabetic cardiovascular complications in subjects treated with Cycloset(TM) compared to placebo, also confirmed the drug's ability to improve glycemic control in subjects failing metformin plus sulfonylurea therapy.

The data were presented by the principle investigator, J. Michael Gaziano, MD, MPH, Cardiologist at Brigham and Women's Hospital and Veteran Affairs Boston Healthcare System, Boston, MA as a late-breaking poster at the 67th Scientific Sessions of the American Diabetes Association in Chicago, Ill. (June 22-26, 2007).

Cycloset(TM) is being investigated as a once-daily, timed oral therapy for type 2 diabetes that acts upon the central nervous system (CNS) to impact peripheral metabolism. The Phase IIIb trial was conducted in response to an approvable letter from the FDA requesting additional data on Cycloset(TM)'s cardiovascular safety.

The double-blind, multi-center trial's 3,070 participants included subjects with type 2 diabetes between the ages of 30 and 80 with HbA1c less than or equal to 10.0 and BMI less than or equal to 43. Participants randomized into the study were all on a treatment regimen for their diabetes, which could include either diet alone, up to two oral hypoglycemic agents, insulin alone, or insulin with no more than one oral agent. Participants were randomized in a 2:1 ratio to Cycloset(TM) (2,054 subjects; titrated from 1.6 mg/day to a
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