Santarus and VeroScience Announce CYCLOSET (bromocriptine mesylate) Data Presentations at the Americ

Santarus and VeroScience Announce CYCLOSET (bromocriptine mesylate) Data Presentations at the American Diabetes Association Meeting

SAN DIEGO & TIVERTON, R.I.--(BUSINESS WIRE)-- Santarus, Inc. (NAS: SNTS) and VeroScience, LLC today announced that clinical data on CYCLOSET® (bromocriptine mesylate) will be featured in two poster presentations at the 73rd Scientific Sessions of the American Diabetes Association being held at McCormick Place in Chicago, Ill. from June 21 - 25, 2013.


The posters will be displayed in the Poster Hall on Saturday, Sunday and Monday, June 22-24 with presentations and author availability scheduled as follows:

  • The Anti-Diabetes Efficacy of Bromocriptine-QR in Type 2 Diabetes Mellitus (T2DM) Subjects is Enhanced Among Those with Elevated Blood Pressure and Plasma Triglyceride Levels
    • Poster Presentation1172-P in category 01-D Clinical Therapeutics/New Technology - Oral Agents, authors available Sunday, June 23, 12:00 p.m. - 2:00 p.m. CDT.
  • Bromocriptine-QR Attenuates the Progression to Both Cardiovascular (CV) Averse Events and Worsening Hyperglycemia in Type 2 Diabetes Mellitus (T2DM) Subjects in Good Glycemic Control
    • Poster Presentation - 1193-P in category 01-F Clinical Therapeutics/New Technology - Pharmacologic Treatment of Complications, authors available Saturday, June 22, 11:30 a.m. - 1:30 p.m. CDT.

CYCLOSET Indications and Usage

  • CYCLOSET is a prescription medication that contains bromocriptine mesylate and is combined with diet and exercise to help control blood sugar in adults with type 2 diabetes mellitus.
  • CYCLOSET is not for people with type 1 diabetes.
  • CYCLOSET is not for people with diabetic ketoacidosis (increased ketones in your blood or urine).

Dosage and Administration

CYCLOSET tablets should be taken once a day within two hours of waking and with food.

Important Safety Information

Warnings and Precautions

  • Do not take CYCLOSET if you are allergic to bromocriptine, other ergot-related drugs, or any of the other ingredients in CYCLOSET.
  • Do not take CYCLOSET if you have been diagnosed with a syncopal migraine.
  • Women who are breast-feeding their children should not take CYCLOSET.
  • CYCLOSET is not for people with type 1 diabetes.
  • CYCLOSET is not for people with diabetic ketoacidosis (increased ketones in your blood or urine).

Adverse Reactions

  • The most common side effects of CYCLOSET include nausea, fatigue, dizziness, vomiting, and headache.
  • CYCLOSET has been associated with low blood pressure (hypotension) with or without symptoms such as dizziness, nausea, and/or excessive sweating. This may occur more frequently during initial therapy or with an increase in dose at any time during your treatment. A sudden drop in blood pressure can result from changes in body position, such as standing up from a seated position or getting out of bed too quickly.
  • CYCLOSET has been associated with increased drowsiness and very rare episodes of sudden sleep onset during daily activities without awareness or warning signs. Exercise caution while driving or operating heavy machinery until you know how CYCLOSET affects your level of alertness.
  • CYCLOSET alone does not usually cause low blood sugar (hypoglycemia). However, low blood sugar may occur when CYCLOSET is used in combination with certain other diabetes medications such as a sulfonylurea or insulin.
    • Signs and symptoms of low blood sugar (hypoglycemia) may include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heart beat, sweating, feeling jittery (nervousness or nervous shaking).

Drug Interactions

  • Tell your doctor about all of the medicines you take, both prescription and non-prescription drugs, including vitamins and herbal supplements. CYCLOSET may interact with other medicines you are currently taking. Your doctor may order laboratory testing to monitor these interactions.
  • Separate taking CYCLOSET and certain migraine medications (ergot derivatives) by at least 6 hours.

CYCLOSET is available by prescription only. For additional information, talk to your doctor and see Full Prescribing Information including Patient Labeling, which is available by clicking here Full Prescribing Information 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 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 www.santarus.com or by contacting Santarus at 1-888-778-0887.

Santarus' product development pipeline includes the investigational drug RUCONEST® (recombinant human C1 esterase inhibitor). A Biologics License Application for RUCONEST for the treatment of acute angioedema attacks in patients with hereditary angioedema is under review by the U.S. Food and Drug Administration with a response expected in April 2014. 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 Commission, including its Quarterly Report on Form 10-Q for the quarter ended March 31, 2013 .

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 registered 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. (sloren@westwicke.com)
(858) 356-5930
or
Robert Uhl (robert.uhl@westwicke.com)
(858) 356-5932
or
VEROSCIENCE CONTACT:
Anthony H. Cincotta, Ph.D.
President and Chief Scientific Officer
(401) 816-0525

KEYWORDS:   United States  North America  California  Illinois  Rhode Island

INDUSTRY KEYWORDS:

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