SAN DIEGO & TIVERTON, R.I. –(BUSINESS WIRE)– Santarus, Inc. (NASDAQ:SNTS) and VeroScience LLC today announced that analyses of 379-patient subset data from a 3,070-patient Phase III safety study conducted with CYCLOSET® (bromocriptine mesylate) tablets suggested that CYCLOSET as an add-on to oral antidiabetes drugs produced improvements in glycemic control irrespective of baseline duration of disease. The findings will be presented Thursday, November 4, 2010 in a poster session at the 8th Annual World Congress on Insulin Resistance , Diabetes & CVD (WCIR) in Los Angeles .
The poster, Duration of Type 2 Diabetes Illness Influence on the Glycemic Control Effect of Cycloset, a Quick Release Formulation of Bromocriptine (M Ezrokhi, et al, Abstract #123), featured a subset analysis of the safety study, investigating the relationship between duration of type 2 diabetes disease and response to treatment with CYCLOSET as an add-on therapy to one or two oral antidiabetes drugs. The subset included 379 patients who had a baseline HbA1c (%) of =7.5 and =10.0, were taking one or two oral antidiabetes drugs (usual diabetic therapy, or UDT), had follow-up data at week 24 of the study and were =127 days drug-compliant. Changes in HbA1c were assessed using linear regression models adjusted for various covariates and stratified by duration of illness. HbA1c is a standard measurement of blood glucose used to determine the efficacy of antidiabetes agents.
The 379 subjects had a mean baseline HbA1c level of 8.3, and mean age was 58 years. The mean duration of type 2 diabetes was 8.1 years (tertiles of duration were defined as <4.74, 4.74—8.56, and >8.56 years). For each tertile, the between group differences in HbA1c for patients treated with CYCLOSET plus UDT compared with those receiving placebo plus UDT were -0.86 (-0.66 CYCLOSET, +0.20 Placebo), -0.66 (-0.47 CYCLOSET, +0.18 Placebo), and -0.53 (-0.62 CYCLOSET, -0.10 Placebo), respectively (P<0.001 for any tertile). Also, for each tertile of duration of disease, 31%, 31% and 35% of subjects on CYCLOSET with UDT versus 12%, 3% and 7% of subjects on placebo plus UDT, respectively, reached goal of HbA1c = 7.0 (P<0.02 for any tertile, unadjusted analysis).
The overall difference in HbA1c for the 379 subjects, adjusting only for baseline HbA1c, was -0.60 (p<0.0001) in favor of the CYCLOSET plus UDT treated group versus those treated with placebo plus UDT. In the fully adjusted model, which adjusted for baseline HbA1c (%), gender (male/female), screening body mass index (kg/m2), age (years), duration (years) as well as diabetes regimen intensification, the between group difference in HbA1c between CYCLOSET plus UDT and placebo plus UDT was -0.62 (p<0.0001).
As in previous studies with the drug, comparison of the improvements in HbA1c versus fasting plasma glucose level suggests that the effect of CYCLOSET to improve glycemic control is via improving both fasting and postprandial glucose levels.
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. 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.
VeroScience is a privately held biotechnology and healthcare product development company with main offices and laboratories in Tiverton, R.I. VeroScience holds the New Drug Application and related technology for CYCLOSET and has a large patent portfolio that supports its preclinical and clinical development programs and product pipeline in the areas of metabolism, immunology and oncology. VeroScience leverages its intellectual property and products in out-licensing and collaborative arrangements with appropriate industry partners.
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. The company plans to commercially launch CYCLOSET in November 2010 .
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, including statements regarding expected timing for launch of CYCLOSET and for initiation of a Phase I clinical study for SAN-300. 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: unexpected adverse side effects or inadequate therapeutic efficacy of Santarus’ products and product candidates; 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 .
Martha L. Hough
VP Finance & Investor Relations
Debra P. Crawford
Chief Financial Officer
Lippert/Heilshorn & Associates, Inc.
Jody Cain ()
Bruce Voss ()
Anthony H. Cincotta, PhD
President and Chief Scientific Officer