Healthcare Industry News: Biovail
News Release - November 15, 2010
Santarus Announces Commercial Launch of Novel Type 2 Diabetes Drug CYCLOSETCYCLOSET is the first and only centrally acting dopamine agonist oral antidiabetic
SAN DIEGO--(Healthcare Sales & Marketing Network)-- 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,” 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.
CYCLOSET is a dopamine receptor agonist that acts on the central nervous system and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. CYCLOSET should not be used to treat type 1 diabetes or diabetic ketoacidosis. Efficacy data in combination with thiazolidinediones are limited. Efficacy has not been confirmed in combination with insulin. Although the precise mechanism of action by which CYCLOSET improves glycemic control in type 2 diabetes patients is unknown, results from preclinical studies suggest that appropriately timed daily administration of bromocriptine normalizes aberrant hypothalamic neurotransmitter activities that induce, potentiate, and maintain the insulin-resistant, glucose-intolerant state. Timed bromocriptine effects on insulin resistance and glucose intolerance have been demonstrated when administered directly to the central nervous system and bypassing the periphery. It has been established that morning administration of CYCLOSET improves glycemic control, particularly postprandial glycemic control, in patients with type 2 diabetes without increasing plasma insulin concentrations. In a 52-week, randomized clinical trial of 3,070 patients, CYCLOSET was not associated with an increased risk for adverse cardiovascular events.
Important Safety Information
CYCLOSET is contraindicated in patients with hypersensitivity to ergot-related drugs, bromocriptine, or any of the excipients in CYCLOSET. Do not use in patients with syncopal migraines. It may precipitate hypotension. Do not use in nursing women. It may inhibit lactation. There are postmarketing reports of stroke in this patient population.
CYCLOSET can cause orthostatic hypotension and syncope, particularly upon initiation or dose escalation. Use with caution in patients taking antihypertensive medications. CYCLOSET may exacerbate psychotic disorders or reduce the effectiveness of drugs that treat psychosis. Use in patients with severe psychotic disorders is not recommended. CYCLOSET may cause somnolence. Advise patients not to operate heavy machinery if symptoms of somnolence occur. Concomitant use with dopamine antagonists such as neuroleptic agents is not recommended.
There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with CYCLOSET or any other antidiabetic drug. CYCLOSET does not increase the risk of macrovascular events. In controlled clinical trials, adverse reactions reported in ≥5% of patients treated with CYCLOSET, and reported more commonly than in patients treated with placebo, included nausea, fatigue, dizziness, vomiting, and headache.
Safety and effectiveness have not been established in pediatric patients.
For full prescribing information please see CYCLOSET Prescribing Information.
Santarus, Inc. is a specialty biopharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by physician specialists. The company’s current commercial efforts are focused on GLUMETZA® (metformin hydrochloride extended release tablets) and CYCLOSET® (bromocriptine mesylate) tablets, which are indicated as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes.
Santarus also has a diverse development pipeline with three late-stage product candidates in Phase III clinical programs: budesonide MMX® for induction of remission of active ulcerative colitis, rifamycin SV MMX® for treatment of travelers’ diarrhea and RHUCIN® (recombinant human C1 inhibitor) for treatment of acute attacks of hereditary angioedema. In addition, Santarus plans to initiate a Phase I clinical study in the first half of 2011 with SAN-300, its anti-VLA-1 antibody, which the company expects to investigate for the treatment of rheumatoid arthritis. More information about Santarus is available on the company’s website at www.santarus.com.
Santarus cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Santarus that any of its plans or objectives will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Santarus’ business, including, without limitation: Santarus’s ability to successfully launch CYCLOSET and generate revenues from CYCLOSET; competition from other products; unexpected adverse side effects or inadequate therapeutic efficacy of Santarus’ products and product candidates; the scope and validity of patent protection for Santarus’ products and product candidates; and other difficulties or delays relating to the development, testing, manufacturing and marketing of, and obtaining and maintaining regulatory approvals for, Santarus’ products and product candidates; and other risks detailed in Santarus’ prior press releases as well as in public periodic filings with the Securities and Exchange Commission.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Santarus undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
Santarus® is a registered trademark of Santarus, Inc. GLUMETZA® is a registered trademark of Biovail Laboratories International S.r.l. licensed exclusively in the United States to Depomed, Inc. CYCLOSET® is a registered trademark of VeroScience LLC. MMX® is a registered trademark of Cosmo Technologies Limited. RHUCIN® is a registered trademark of Pharming Group NV.
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