Andrx Receives FDA Approval on Additional Indication for Altocor.

Business Editors/Health & Medical Writers

FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Sept. 12, 2002

Andrx Corporation (Nasdaq:ADRX) today announced that the United States Food and Drug Administration (FDA) has granted final approval for use of Altocor(TM) (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. Given the National Cholesterol Education Panel's statement that 36 million Americans are candidates for cholesterol-lowering therapy, including an increased number of primary prevention patients, this indication will expand Altocor's potential patient population.

Commenting on this approval, Richard J. Lane, Andrx Chief Executive Officer, said: "This is our second FDA approval within 3 months on the brand side of our business, and demonstrates Andrx's ability to execute its branded drug strategy. I believe it is particularly notable given the delays affecting FDA approval of some of our competitors' products. This new indication will allow Andrx to promote Altocor for the prevention of heart attacks in people without known existing heart disease. Since this group represents the majority of people eligible for treatment, the primary prevention indication is an important enhancement of Altocor's efficacy profile that will allow a much larger group of patients to benefit from Altocor treatment. The benefits of this indication and the AFCAPS/TexCAPS study were not previously promoted, and we believe it represents a significant opportunity for Andrx and Altocor."

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(TM) 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. Lovastatin has a long history of safe use with over 24 million patient-years of exposure. The United States market for lipid lowering drugs in which Altocor competes currently exceeds $12 billion per year and is expected to continue to grow.

In clinical studies with Altocor, adverse reactions have generally been mild and transient. Pooled results from clinical studies with Altocor show that the most frequently reported adverse reactions in the Altocor group were infection, headache and accidental injury. Similar incidences of these adverse reactions were seen in the Altocor and placebo groups. The most frequent adverse events thought to be related to Altocor were nausea, abdominal pain, insomnia, dyspepsia, headache, asthenia and myalgia. Lovastatin and other inhibitors of HMG-CoA reductase occasionally cause myopathy and liver dysfunction. These effects and other safety and efficacy information are summarized in the Altocor Package Insert. The full prescribing information is available on Andrx's website at http://www.andrx.com.

Andrx Corporation is a specialty pharmaceutical company engaged in the formulation and commercialization of oral controlled-release generic and brand pharmaceuticals utilizing its proprietary drug delivery technologies. Andrx also distributes generic pharmaceutical products manufactured by third parties to independent pharmacies and non-warehousing chains.

Forward-looking statements (statements which are not historical facts) in this release are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. For this purpose, any statements contained in this report that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, no assurance can be given as to whether this new indication will significantly affect the commercial success of Altocor and the role, if any, of lovastatin in the treatment and prevention of stroke and Alzheimer's disease, and words such as "may," "will," "to," "expect," "plan," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative or other variations thereof or comparable terminology is intended to identify forward-looking statements. Investors are cautioned that all forward-looking statements involve risks and uncertainties, including those risks and uncertainties detailed in the Company's filings with the Securities and Exchange Commission.

This release and additional information about Andrx Corporation are also available on the Internet at: http://www.andrx.com