Healthcare Industry News: Prothrombin Time
News Release - February 6, 2012
Santarus Begins Promoting Cholesterol-Lowering Product FENOGLIDECompletes sales force expansion to 150 representatives
SAN DIEGO--(Healthcare Sales & Marketing Network)--Santarus, Inc. (NASDAQ: SNTS ) today announced that it has commenced promotion of prescription FENOGLIDE® (fenofibrate) tablets 40 mg and 120 mg to selected physicians in the U.S. FENOGLIDE is indicated as an adjunct to diet to reduce elevated low-density lipoprotein-cholesterol (LDL-C), total cholesterol, triglycerides and apolipoprotein B (Apo B), and to increase high-density lipoprotein-cholesterol (HDL-C) in adult patients with primary hyperlipidemia or mixed dyslipidemia. FENOGLIDE also is indicated as an adjunct to diet for treatment of adult patients with hypertriglyceridemia.
“We are now promoting FENOGLIDE with our expanded sales force of approximately 150 sales representatives,” said William C. Denby, senior vice president, commercial operations. “High cholesterol is a co-morbid condition frequently associated with type 2 diabetes, which makes FENOGLIDE a good fit with our ongoing promotion of GLUMETZA® and CYCLOSET® for patients with type 2 diabetes.”
He added, “We intend to improve patient access to FENOGLIDE through an electronic Voucher program that generally provides for a $10 co-pay at participating retail pharmacies for patients with commercial insurance. We are seeing positive results from a similar patient co-pay assistance program for GLUMETZA.”
In December 2011 Santarus entered into a license agreement with Shore Therapeutics, Inc. under which Santarus obtained exclusive rights to commercialize FENOGLIDE in the U.S. market.
About FENOGLIDE (fenofibrate) tablets
FENOGLIDE is a prescription medicine for the treatment of high cholesterol. Along with a healthy diet, FENOGLIDE lowers “bad” cholesterol (LDL-C) and triglycerides and increases “good” cholesterol (HDL-C).
Fenofibrate was not shown to lower the risk of illness and death related to heart disease in patients with type 2 diabetes.
Important Safety Information
FENOGLIDE is contraindicated in patients with severe renal dysfunction, including those receiving dialysis, active liver disease, gallbladder disease, nursing mothers, and in patients with known hypersensitivity to fenofibrate.
Fenofibrate may increase serum transaminases. Regular periodic liver tests should be performed, and therapy discontinued if enzyme levels persist >3 times the normal limit.
Fenofibrate may lead to cholelithiasis (gallstones). If cholelithiasis is suspected, gallbladder studies are indicated. Discontinue FENOGLIDE if gallstones are found.
Myopathy and rhabdomyolysis have been reported in patients taking fenofibrate. The risk for serious muscle toxicity appears to be increased in elderly patients and in patients with diabetes, renal failure, or hypothyroidism.
Fenofibrate reversibly increases serum creatinine levels.
The most common adverse reactions (>2% and at least 1% greater than placebo) are abnormal liver tests, increased AST, increased ALT, increased CPK, and rhinitis.
Potential drug-drug interactions can occur with cyclosporine, HMG-CoA reductase inhibitors, and bile-acid resins. Exercise caution in concomitant treatment with coumarin anticoagulants. Reduce the dosage of coumarin to maintain the Prothrombin Time/INR at the desired level to prevent bleeding complications. Please refer to the Full Prescribing Information for additional information.
Fenofibrate should be avoided in patients with severe renal impairment and dose reduction is required in patients with mild to moderate renal impairment. Dose selection for the elderly should be made on the basis of renal function.
Please visit www.Fenoglide.com for Full 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, and on FENOGLIDE® (fenofibrate) tablets, which is indicated as an adjunct to diet to reduce high cholesterol.
Santarus also has a diverse pipeline, including three investigational drugs in late-stage clinical development: UCERIS™ (budesonide) tablets for induction of remission of active ulcerative colitis, RHUCIN® (recombinant human C1 inhibitor) for treatment of acute attacks of hereditary angioedema and rifamycin SV MMX® for treatment of travelers’ diarrhea, in addition to other earlier-stage development programs. More information about Santarus is available at www.santarus.com.
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 its plans 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 related to the license agreement between Shore and Santarus (including Santarus’ ability to increase market demand and sales of FENOGLIDE products; competition from other products, unexpected adverse side effects or inadequate therapeutic efficacy of FENOGLIDE products; Santarus’ ability to ensure continued supply of FENOGLIDE products in the U.S. market; the scope and validity of patent protection for FENOGLIDE products and the outcome of current patent litigation; and the potential for termination of the license agreement); Santarus’ ability to generate revenues from GLUMETZA and CYCLOSET; Santarus’ ability to successfully advance the development of, obtain regulatory approval for and ultimately commercialize, its development product candidates; other difficulties or delays relating to the development, testing, manufacturing and marketing of, and obtaining and maintaining regulatory approvals for, Santarus and its strategic partners’ products; fluctuations in quarterly and annual results; and other risks detailed in Santarus’ prior press releases and 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® and UCERIS™ 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. RHUCIN® is a trademark of Pharming Group NV.
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