Santarus and VeroScience Announce Publication of Positive Data from Pivotal CYCLOSET® (bromocriptine mesylate) Efficacy Study

 

 

January 23, 2013

 

Santarus and VeroScience Announce Publication of Positive Data from Pivotal CYCLOSET® (bromocriptine mesylate) Efficacy Study

CYCLOSET add-on therapy provided significant improvement in glycemic control versus placebo in patients with type 2 diabetes poorly controlled on one or two oral anti-diabetes medications

SAN DIEGO & TIVERTON, R.I. --(BUSINESS WIRE)-- Santarus, Inc. (NASDAQ: SNTS) and VeroScience, LLC today announced publication of positive data from a double-blind, placebo-controlled, multi-center pivotal study with CYCLOSET® (bromocriptine mesylate) tablets. Patient groups in the evaluable per protocol (EPP) population that added CYCLOSET to their treatment regimen achieved a 0.60% to 0.70% reduction in HbA1c (p < 0.0001) relative to placebo after 24 weeks, the primary endpoint of the study. These results appear in the November/ December 2012 print edition of Endocrine Practice, a peer-reviewed medical journal.

Additionally, among the EPP population with no concomitant change in diabetes medication, treatment with CYCLOSET resulted in:

CYCLOSET is a unique, quick release form of bromocriptine, a dopamine receptor agonist that is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The study included 515 patients with type 2 diabetes with baseline HbA1c of ≥7.5% and ≤10.0% (average baseline HbA1c: 8.3) taking one or two oral anti-diabetes medications (metformin, sulfonylurea and/or thiazolidinediones). These poorly controlled patients were randomized 2:1 to CYCLOSET add-on (1.6 mg/day to 4.8 mg/day) or placebo add-on for a 24-week treatment period. Study investigators were allowed to adjust patient anti-diabetes medications during the study to attempt to achieve glycemic control in case of glycemic deterioration. The impact of CYCLOSET treatment was assessed in patients taking: (1) one or two oral anti-diabetes medications, (2) metformin with or without another oral anti-diabetes medication, or (3) metformin plus a sulfonylurea. The study was conducted in a cohort of patients imbedded in a larger randomized safety study.

The results of the primary endpoint analysis for the intent-to-treat (ITT) and EPP populations are summarized in the table below.

 

Effect of CYCLOSET Versus Placebo on Change from Baseline HbA1c (%)a

and Odds Ratio of Achieving Goal of HbA1c ≤ 7.0
ITT EPP EPP

Any one or two oral anti-diabetes

No concomitant change

medications

in diabetes medication

N=515

N=379

N=272
Between group difference HbA1c -0.51 (-0.70, -0.31)b -0.60 (-0.83, -0.38)b -0.69 (-0.97, -0.41)b
Odds ratio of achieving HbA1c ≤ 7.0 3.48 (1.96, 6.18)b 5.80 (2.93, 11.47)b 6.50 (2.67, 15.84)b
ITT EPP EPP
Metformin with or without another No concomitant change
oral anti-diabetes medication in diabetes medication
N=356 N=262 N=198
Between group difference HbA1c -0.56 (-0.78, -0.34)b -0.68 (-0.93, -0.42)b -0.81 (-1.12, -0.51)b
Odds ratio of achieving HbA1c ≤ 7.0 3.98 (1.98, 7.98)b 6.69 (2.98, 15.04)b 12.03 (3.53, 40.99)b
ITT EPP EPP
Metformin plus a sulfonylurea No concomitant change
in diabetes medication
N=245 N=179 N=129
Between group difference HbA1c -0.49 (-0.75, -0.24)c -0.70 (-1.00, -0.40)b -0.83 (-1.18, -0.48)b
Odds ratio of achieving HbA1c ≤ 7.0 3.77 (1.72, 8.30)d 7.26 (2.92, 18.01)c 11.45 (3.19, 41.12)c

aValues are based on mean (95% Confidence Interval), adjusted by baseline HbA1c

bp < 0.0001

cp < 0.0002

dp < 0.001

 

The most frequent adverse events in the study for CYCLOSET and placebo were, respectively, nausea (33% vs. 6%), fatigue (11% vs. 8%), dizziness (14% vs. 11%), headache (12% vs. 8%), constipation (7% vs. 3%), back pain (6% vs. 3%) and vomiting (6% vs. 2%). The discontinuation rate due to any adverse event was 20% for CYCLOSET-treated and 9% for placebo-treated patients.

"The results of this pivotal study show that the addition of CYCLOSET to the treatment regimen in this poorly controlled type 2 diabetes patient population produces significant and clinically relevant improvements in glycemic control markedly increasing the percent of patients reaching the HbA1c goal of ≤ 7.0 vs. placebo," stated Aaron I. Vinik, M.D., Ph.D, Strelitz Diabetes Center and Neuroendocrine Unit, Norfolk, Virginia and lead author of the paper.

The article, titled Effect of Bromocriptine-QR on Glycemic Control in Subjects with Uncontrolled Hyperglycemia on One or Two Oral Anti-Diabetes Agents can be found online at http://www.ncbi.nlm.nih.gov/pubmed/23186965.

Important Safety Information

CYCLOSET is a dopamine receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Contraindications

CYCLOSET is contraindicated in:

Warnings and Precautions

Adverse Reactions

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.

Postmarketing reports with higher doses of bromocriptine used for other indications include psychotic disorders, hallucinations, and fibrotic complications.

Drug Interactions

The Important Safety Information does not include all the information needed to use CYCLOSET safely and effectively. See Full Prescribing Information for CYCLOSET for additional information, available at www.cycloset.com or by contacting Santarus at (888) 778-0887.

About VeroScience

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.

About Santarus

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, and on FENOGLIDE®(fenofibrate) tablets, which is indicated as an adjunct to diet to reduce high cholesterol. In March 2013 , the company plans to begin promoting UCERIS(budesonide) extended release tablets for the induction of remission of active, mild to moderate ulcerative colitis and ZEGERID® (omeprazole/sodium bicarbonate) for the treatment of certain upper gastrointestinal disorders. Safety information and full prescribing information for Santarus' products are available at www.santarus.com.

Santarus' product development pipeline includes the investigational drug RUCONEST® (recombinant human C1 esterase inhibitor) for treatment of acute attacks of hereditary angioedema. The company expects to submit a biologics license application (BLA) to the U.S. Food and Drug Administration for RUCONEST in the first half of 2013. Santarus is also developing rifamycin SV MMX®, which is in Phase III clinical testing for treatment of travelers' diarrhea. In addition, SAN-300, the company's investigational monoclonal antibody, is in Phase I clinical testing. More information about Santarus is available 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: risks associated with the collaboration relating to CYCLOSET, including the potential for termination of the collaboration; 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 prior 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 ®, FENOGLIDE®, UCERIS and ZEGERID®are trademarks of Santarus, Inc. GLUMETZA®is a trademark of Biovail Laboratories International S.r.l. licensed exclusively in the United States to Depomed, Inc. CYCLOSET®is a trademark of VeroScience LLC . MMX®is a trademark of Cosmo Technologies Limited . RUCONEST®is a trademark of Pharming Group N.V.

SANTARUS CONTACTS:
Martha L. Hough
VP Finance & Investor Relations
858-314-5824
or
Debra P. Crawford
Chief Financial Officer
858-314-5708
or
Westwicke Partners, LLC
Stefan Loren, Ph.D., 858-356-5930
sloren@westwicke.com
or
Robert Uhl, 858-356-5932
robert.uhl@westwicke.com
or
VEROSCIENCE CONTACT:
Anthony H. Cincotta, Ph.D.
President and Chief Scientific Officer
401-816-0525

 

 

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