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FDA approves additional indication for Altocor

FORT LAUDERDALE, FLA., Sept. 12, 2002 -- Andrx Corporation announced that the FDA has granted final approval for use of Altocor (lovastatin extended release) for the primary prevention of coronary heart disease in patients without symptomatic cardiovascular disease who have average to moderately elevated total cholesterol and LDL-cholesterol and below average HDL-cholesterol.

For primary prevention, Altocor is now indicated to reduce the risk of heart attack, unstable angina and coronary revascularization procedures.

The FDA also approved the expansion of the Altocor Package Insert to include additional efficacy data demonstrating the effect of lovastatin on regression of atherosclerosis of the carotid arteries, which supply blood to the brain.

Andrx believes that these new approvals will significantly expand the patient population that will benefit from Altocor therapy. Andrx began marketing Altocor in July 2002 for the treatment of patients with coronary heart disease and hyperlipidemia.    

This new indication resulted from the AFCAPS/TexCAPS study that investigated prevention of heart attacks in people devoid of heart disease. The primary prevention indication covers the majority of patients eligible for treatment with statin drugs.

The National Cholesterol Education Panel has stated that 36 million Americans are candidates for cholesterol-lowering therapy, including an increased number of primary prevention patients.

Lawrence T. Friedhoff, MD, PhD, Executive Vice President of Research and Development of Andrx Laboratories, commented: "The primary prevention indication and the effects on regression of lesions in the arteries supplying the brain, coupled with Altocor's impressive 41% average LDL-cholesterol lowering at its 60mg starting dose make Altocor a significant competitor among lipid-lowering drugs.

"Furthermore, as research into the role of lovastatin in the treatment and prevention of stroke and Alzheimer's disease progresses, the effects of lovastatin on the carotid arteries may take on increasing significance."    

Altocor is a once-daily, extended-release HMG-CoA reductase inhibitor product, which was already indicated as an adjunct to diet for the reduction of elevated total-cholesterol, LDL-cholesterol, Apolipoprotein B, and triglycerides, and to increase HDL-cholesterol in patients with primary hypercholesterolemia and mixed dyslipidemia.

Altocor is also indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower total cholesterol and LDL-cholesterol to target levels. The new primary prevention indication adds to this list of approved indications for Altocor    

Since lovastatin has a relatively short half-life in the body, Altocor utilizes Andrx's patented and proprietary SCOT technology to achieve sustained blood levels of the drug, resulting in average LDL-cholesterol lowering of 24% to 41% for the 10 mg to 60 mg approved dose range.

Posted: September 2002