Lower-Cost Alternative to TriLipix® (fenofibric acid) and Market-Leading Fibrate Therapy TriCor® (fenofibrate)
PHILADELPHIA, November 2, 2009 – URL Pharma, Inc. today announced the immediate U.S. market availability of Fibricor™ (fenofibric acid) for the treatment of primary hyperlipidemia, mixed dyslipidemia and severe hypertriglyceridemia. The U.S. Food and Drug Administration (FDA) granted approval of Fibricor on August 14, 2009. Fibricor represents a lower-cost alternative to TriCor® (fenofibrate), the market-leading fibrate therapy, and TriLipix® (fenofibric acid) for patients who need fibrate therapy. Fibricor is marketed by AR Scientific, a subsidiary of URL Pharma.
The active ingredient in Fibricor is fenofibric acid, the same active ingredient found in TriLipix. Additionally, absorption of Fibricor has been shown to be bioequivalent to TriCor under fasted conditions and following a standard meal. Fibricor is available in 35mg and 105mg tablets and can be taken without regard to food.
Fibricor will be sold at a lower price than TriCor or TriLipix. Patients bringing a Fibricor prescription to the pharmacy will, under most health plan coverage, have their prescription filled affordably with a generic at a tier-1 co-pay, saving patients up to 60 percent compared to other branded fibrates.
“We are pleased to offer patients and physicians a lower-cost option for those who need to manage high triglycerides and cholesterol,” said Richard H. Roberts, M.D., Ph.D, President, CEO and Chairman of URL Pharma. “Fibricor is a sensible alternative that provides patients with significant clinical and economic value.”
Hyperlipidemia is an elevation of lipids (fats) in the bloodstream, including total cholesterol, LDL (“bad”) cholesterol and triglycerides. Mixed dyslipidemia is characterized by the presence of elevated LDL cholesterol and triglycerides, and low levels of HDL (“good”) cholesterol. Hypertriglyceridemia refers to the presence of excessively high levels of triglycerides in the blood. Elevated cholesterol and triglyceride levels, along with low HDL, are major yet highly modifiable risk factors for cardiovascular disease. Fibrates like Fibricor help lower levels of triglycerides (TG), total cholesterol and LDL (“bad”) cholesterol, and increase levels of HDL (“good”) cholesterol.
Important Safety Information
FIBRICOR should not be used by patients with severe loss of kidney function, including those receiving dialysis, or by patients with liver disease or gallbladder disease. FIBRICOR should also not be used by women who are nursing or people who are allergic to FIBRICOR, fenofibric acid, or fenofibrate. FIBRICOR should not be taken by children.
Some patients taking FIBRICOR have developed unusual liver functions. Although uncommon, other potential side effects of FIBRICOR include formation of gallstones, muscle pain or weakness, changes in kidney function, and coronary heart disease. Your doctor may periodically perform a simple blood test to monitor the health of your liver or kidneys while taking FIBRICOR. You should tell your doctor about any changes to your condition while taking FIBRICOR. Be sure to tell your doctor if you experience muscle pain, tenderness, or weakness (especially if it is accompanied by a fever or “run-down” feeling); abdominal pain; or if you develop any new symptoms.
In clinical trials, the most common side effects of FIBRICOR were changes in liver function, abdominal pain, back pain, and headaches.
You are encouraged to report negative side effects of prescription drugs to the F
DA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Full prescribing information can be found at www.fibricor.com.
URL Pharma is establishing a Fibricor patient assistance program (PAP) for patients who are qualified. The program is expected to launch by the fourth quarter of 2009.
About URL Pharma
URL Pharma, Inc., headquartered in Philadelphia, PA, is a leading specialty pharmaceutical company with fully integrated technology development, product development, manufacturing, and commercialization capabilities. After a long history of generic pharmaceutical research, development, and manufacturing, the Company has successfully transitioned to a profitable, technology-driven, specialty pharmaceutical business. The Company seeks to develop and commercialize scientifically and medically innovative products that address unmet medical needs for improvements in safety and efficacy. The Company’s profits are derived predominantly from its exclusive products and technologies. For additional information about the company, please visit www.urlpharma.com.
For further information, please call 215-697-1900 or media@urlpharma.com.
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TriCor® and TriLipix® are registered trademarks of Fournier Industrie et Santé Corporation, France.