Santarus announces commercial U.S. launch of CYCLOSET for type 2 diabetes mellitus

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Santarus, Inc. (NASDAQ: SNTS), a specialty biopharmaceutical company, today announced the commercial U.S. launch of CYCLOSET® (bromocriptine mesylate) tablets. CYCLOSET is a prescription drug approved by the U.S. Food and Drug Administration (FDA) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus both as monotherapy and in combination with other oral antidiabetic agents.

“We are pleased to announce that CYCLOSET is now available through retail pharmacies”

"We are pleased to announce that CYCLOSET is now available through retail pharmacies," said Gerald T. Proehl, president and chief executive officer of Santarus. "Our commercial organization, which includes approximately 110 sales representatives, is excited about the addition of CYCLOSET with its novel approach to treating patients with type 2 diabetes and the overlap with our current called-on physicians for GLUMETZA®. Our promotion focuses on CYCLOSET's consistent glycemic control and cardiovascular safety, which were demonstrated in a 3,070-patient clinical study."

Ralph A. DeFronzo, M.D., Professor of Medicine, Chief of the Diabetes Division, University of Texas Health Sciences Center, San Antonio, said, "CYCLOSET represents a new treatment for adults with type 2 diabetes. Although the mechanism by which CYCLOSET improves glycemic control is unknown, it contains bromocriptine mesylate, which increases dopaminergic activity in the hypothalamus. In a clinical trial, CYCLOSET lowered HbA1c by 0.6% to 0.9% relative to placebo, when added to other oral antidiabetic agents. CYCLOSET can be prescribed for adults who are inadequately controlled with diet/exercise, metformin, sulfonylureas or thiazolidinediones."

A 24-week, placebo-controlled, monotherapy study of the impact of CYCLOSET on glycemic control in 159 overweight adults (BMI ≥ 26.0 kg/m2 for males and ≥ 28.0 kg/m2 for females) with type 2 diabetes and baseline HbA1c of 7.5% - 11% indicated that once-daily morning dosing of CYCLOSET provided significant postprandial plasma glucose reductions throughout the day without increasing plasma insulin concentrations and significantly improved HbA1c.

Additional data from a prospective 24-week assessment of the efficacy of CYCLOSET in improving glycemic control in type 2 diabetes, patients poorly controlled on one or two oral anti-diabetes agents indicated that 35% - 40% of patients reached an HbA1c goal of ≤ 7.0% with CYCLOSET versus approximately 10% of placebo treated patients. When added to other oral antidiabetic agents, once-daily morning administration of CYCLOSET improved glycemic control after 24 weeks of treatment, as demonstrated by a significant reduction in mean HbA1c (0.6% - 0.9% versus placebo, data on file). These findings were from a prospective 24-week assessment for treatment differences in the change from baseline to Week 24 in HbA1c among patients with a baseline HbA1c ≥7.5%, taking one or two oral antidiabetic medications, and completing 24 weeks of therapy within a 52-week, randomized controlled study to evaluate the safety and efficacy of CYCLOSET. In this 52-week study, CYCLOSET was not associated with an increased risk for adverse cardiovascular events relative to placebo.

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