Andrx to Present Alzheimer's Disease and Diabetes Results at American College of Clinical Pharmacology Meeting.

Business Editors/Health & Medical Writers

FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Sept. 20, 2002

Andrx Corporation (Nasdaq:ADRX) today announced that it plans to present data on its extended-release formulations of lovastatin, Altocor(TM), including data from a Phase 2 clinical trial evaluating the use of Altocor in patients with Alzheimer's disease (AD), as well as data regarding metformin (Metformin XT) at the 31st Annual Meeting of the American College of Clinical Pharmacology, September 21-23, 2002, in San Francisco, California.

Commenting on the findings of the Phase 2 Altocor/AD study, Lawrence T. Friedhoff, MD, PhD, Executive Vice President of Research and Development of Andrx Laboratories, said: "This is one of the few prospective clinical trials that was specifically designed to evaluate the effects of a statin drug in patients with diagnosed AD. These results are important in view of recent epidemiologic publications in the medical literature, giving evidence that patients taking statins have a reduced risk of AD. Altocor is one of the few statin drugs that crosses the blood-brain-barrier and enters the brain, the target organ in AD. In addition, Altocor, which is patented and uses Andrx's SCOT(TM) technology, optimizes the drug's pharmacokinetic profile: blood levels are smoother and more sustained."

The trial was a multicenter, randomized, double-blind, placebo-controlled, multi-dose, sequential trial exposing three successive groups of AD patients to 20mg, 40mg, and 80mg of Altocor or to placebo. The patients, with mild to moderately severe AD, were exposed to the test drug for 28 days. The trial evaluated safety, effects on blood lipids, and effects on blood concentrations (of lovastatin and its active metabolite) of the three Altocor doses.

Results showed that in AD patients treated with this dosage range (20mg - 80mg) low-density lipoprotein cholesterol (LDL-C) was reduced by 30% - 44%, total cholesterol (TC) was reduced by 18% - 31%, and triglycerides (TG) by 17% - 19%. Changes in high-density lipoprotein cholesterol (HDL-C) were small. Blood concentrations of lovastatin and its active metabolite increased as dose increased. Tolerability was comparable to placebo at all doses, and no clinically important side-effects occurred. Preliminary data also suggested that Altocor reduced levels of C-reactive protein, a marker of inflammation, and independent predictor of atherosclerosis. Andrx's data will be presented in Abstract 050: The pharmacokinetics, pharmacodynamics, and tolerance of extended-release lovastatin in Alzheimer's disease.

Alzheimer's disease is the leading cause of dementia in the western world. It is a chronic, progressive disease of the brain that impairs memory, judgment, and other cognitive functions.

Previously, Andrx had published data showing that Altocor significantly reduces blood concentrations of beta amyloid in patients with high cholesterol. Beta amyloid is believed to play a central role in the evolution of the brain damage seen in AD.

In separate presentations, Andrx will provide additional data on Altocor and Metformin XT. The abstracts are as follows:

Abstract 052: Pharmacokinetics and pharmacodynamics of extended-release lovastatin;

Abstract 056: Effects of food on the absorption of lovastatin following administration from an extended-release dosage form;

Abstract 055: Pharmacokinetic variability of an extended-release lovastatin formulation;

Abstract 051: Multiple-dose pharmacokinetics of extended-release metformin;

Abstract 053: Pharmacokinetics of extended-release metformin versus immediate-release metformin in healthy subjects; and

Abstract 054: Pharmacokinetics of extended-release metformin vs. immediate release metformin in Type 2 diabetic patients.

Altocor, a once daily, extended-release formulation of lovastatin, is indicated for the primary prevention of coronary heart disease. In individuals without symptomatic cardiovascular disease, average to moderately elevated TC and LDL-C, and below average HDL-C, Altocor is indicated to reduce the risk of myocardial infarction, unstable angina, and coronary revascularization procedures. 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 TC and LDL-C to target levels. Altocor is also indicated as an adjunct to diet for the reduction of elevated TC, LDL-C, Apolipoprotein B, and triglycerides, and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia. Andrx began marketing Altocor in July 2002. The full prescribing information for Altocor is available on Andrx's website at http://www.andrx.com.

Metformin is an oral anti-hyperglycemic agent currently used in the management of Type 2 diabetes mellitus, which is also known as non-insulin dependent diabetes mellitus of NIDDM. Metformin XT, which is patented and uses Andrx's Single Composition Osmotic Table (SCOT) drug delivery technology, is an investigational extended-release formulation. Andrx is planning to file a New Drug Application (NDA) for Metformin XT in the fourth quarter of 2002.

The abstracts for these presentations are published in the September 2002 issue of the Journal of Clinical Pharmacology.

About Andrx

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 markets and distributes pharmaceutical products manufactured by third parties. This release and additional information about Andrx Corporation are also available on the Internet at: http://www.andrx.com.

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, 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 but not limited to, its ability to develop and commercialize Altocor and Metformin XT as described herein and Andrx's results of operations. The Company is also subject to other risks as detailed from time-to-time in the Company's filings with the Securities and Exchange Commission.