CYCLOSET (bromocriptine mesylate) Included in American Association of
Clinical Endocrinologists Comprehensive Diabetes Management Algorithm
CYCLOSET is recommended for dual therapy for patients with entry HbA1c ≥ 7.5%
SAN DIEGO & TIVERTON, R.I. -- May 02, 2013
Santarus, Inc. (NASDAQ: SNTS) and VeroScience, LLC today announced the
inclusion of CYCLOSET^® (bromocriptine mesylate) as a therapy for patients
with type 2 diabetes in a new comprehensive diabetes management algorithm
published by the American Association of Clinical Endocrinologists (AACE). The
AACE created the algorithm to guide primary care physicians, endocrinologists
and other health care professionals in the treatment of prediabetes and type 2
*For patients with entry hemoglobin A1c (HbA1c) ≥ 7.5%, the AACE algorithm
recommends dual therapy to include CYCLOSET as one option in combination
with metformin or another first-line agent.
*CYCLOSET is also listed as a treatment option for patients that need
triple therapy and for those patients without symptoms that present with
an HbA1c > 9.0%.
In support of the new treatment algorithm, AACE provides a matrix profiling
attributes of several anti-diabetes medications. The matrix highlights the
demonstrated cardiovascular safety profile of CYCLOSET and provides a
“neutral” rating for CYCLOSET for hypoglycemia, weight gain, renal function,
congestive heart failure and bone loss, and a “moderate” rating for GI
“Choosing appropriate therapies for patients with type 2 diabetes is
challenging and must be individualized based on a number of patient risk
factors. CYCLOSET is an interesting and useful therapy, both because of its
beneficial impact on HbA1c and the fact that in clinical testing it was not
associated with increased risk for adverse cardiovascular events,”* according
to Alan J. Garber, M.D., Ph.D., FACE, professor of medicine, biochemistry and
molecular biology, and molecular and cellular biology in the Division of
Diabetes, Endocrinology and Metabolism at the Baylor College of Medicine in
Houston, Texas, and chair of the algorithm task force and president of AACE.
“We believe that the addition of CYCLOSET to the AACE comprehensive diabetes
management algorithm will increase awareness and exposure for CYCLOSET with
endocrinologists and other physicians who as of yet may not prescribe it for
their adult patients with type 2 diabetes,” said Thomas J. Joyce, vice
president, marketing and national accounts of Santarus.
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.
CYCLOSET is contraindicated in:
*Patients with known hypersensitivity to bromocriptine, ergot-related
drugs, or any of the excipients in CYCLOSET.
*Patients with syncopal migraine. Bromocriptine increases the likelihood of
a hypotensive episode among patients with syncopal migraine. Loss of
consciousness during a migraine may reflect dopamine receptor
hypersensitivity. CYCLOSET is a dopamine receptor agonist, and may,
therefore, potentiate the risk for syncope in these patients.
*Women who are nursing their children. CYCLOSET may inhibit lactation.
There are postmarketing reports of stroke in this patient population
although causality has not been proven.
Warnings and Precautions
*Hypotension: Can cause orthostatic hypotension and syncope, particularly
upon initiation or dose escalation. Use caution in patients taking
anti-hypertensive medications. Assess orthostatic vital signs prior to
initiation of CYCLOSET and periodically thereafter. Advise patients during
early treatment to avoid situations that could lead to injury if syncope
was to occur.
*Psychosis: May exacerbate psychotic disorders or reduce the effectiveness
of drugs that treat psychosis. Use in patients with severe psychotic
disorders is not recommended.
*Somnolence: May cause somnolence. Advise patients not to operate heavy
machinery if symptoms of somnolence occur.
*Interaction with dopamine antagonists: Concomitant use with dopamine
antagonists such as neuroleptic agents may diminish the effectiveness of
both drugs. Concomitant use is not recommended.
*Other dopamine receptor agonists: Effectiveness and safety are unknown in
patients already taking dopamine receptor agonists for other indications.
Concomitant use is not recommended.
*Macrovascular outcomes: There have been no clinical studies establishing
conclusive evidence of macrovascular risk reduction with CYCLOSET or any
other anti-diabetes drug. CYCLOSET does not increase the risk of
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
*May increase the unbound fraction of highly protein-bound therapies,
altering their effectiveness and safety profiles.
*May increase ergot-related side effects or reduce ergot effectiveness for
migraines if co-administered within 6 hours of ergot-related drugs.
*Extensively metabolized by CYP3A4. Use caution when co-administering
strong inhibitors, inducers, or substrates for CYP3A4.
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.
*Findings from a 52-week, 74-center, randomized placebo-controlled trial to
evaluate the safety of CYCLOSET. 3,070 patients were randomized 2:1 to add
either CYCLOSET or placebo, respectively, to their current anti-diabetes
regimen, which could consist of diet alone or no more than two agents; two
oral anti-diabetes (OAD) medications or insulin + one OAD. Inclusion criteria:
age 30-80, BMI <43 kg/m^2, diagnosis of type 2 diabetes of > 6 months with an
A1c ≤10.0% with no lower A1c boundary. Patients with a history of
cardiovascular disease and congestive heart failure were included in the
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
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 five products. UCERIS^™ ^ (budesonide) extended release
tablets for the induction of remission in patients with active, mild to
moderate ulcerative colitis and ZEGERID^® (omeprazole/sodium bicarbonate) for
the treatment of certain upper gastrointestinal disorders are promoted to
gastroenterologists. 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 FENOGLIDE^® (fenofibrate) tablets, which is indicated as
an adjunct to diet to reduce high cholesterol, are promoted to
endocrinologists and other physicians who treat patients with type 2 diabetes.
Full prescribing and safety information for Santarus’ products is available at
Santarus’ product development pipeline includes the investigational drug
RUCONEST^® (recombinant human C1 esterase inhibitor). A biologics license
application (BLA) for RUCONEST was submitted to the FDA in April 2013 for the
treatment of acute angioedema attacks in patients with hereditary angioedema
(HAE). Santarus is also developing rifamycin SV MMX^®, which is in Phase III
clinical testing for treatment of travelers’ diarrhea. In addition, the
company has completed a Phase I clinical program with SAN-300, an
investigational monoclonal antibody. 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
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.
Martha L. Hough, 858-314-5824
VP Finance & Investor Relations
Debra P. Crawford, 858-314-5708
Chief Financial Officer
Westwicke Partners, LLC for Santarus, Inc.
Stefan Loren, Ph.D., 858-356-5930
Robert Uhl, 858-356-5932
Anthony H. Cincotta, Ph.D., 401-816-0525
President and Chief Scientific Officer
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