King Pharmaceuticals Reports Publication of HOPE-TOO Clinical Trial Results Showing Sustained Effect of ALTACE(R) in Reducing Risk of Cardiovascular Events

BRISTOL, Tenn., Sept. 6 /PRNewswire-FirstCall/ — King Pharmaceuticals, Inc. today reported the publication of the results of the Heart Outcomes Prevention Evaluation – The Ongoing Outcomes (“HOPE-TOO”). The HOPE- TOO results are published in an article entitled “Long-Term Effects of Ramipril on Cardiovascular Events and on Diabetes” which appears in the August 30, 2005 issue of Circulation, a publication of the American Heart Association.

After seven years of patient follow-up, the HOPE-TOO trial demonstrates the sustained effect of ALTACE(R) (“ramipril”), an angiotensin converting enzyme (“ACE”) inhibitor, on reducing the risk of cardiovascular events and sustained vascular and metabolic benefits for patients treated with ramipril. The authors of the article also concluded that the data indicated that a patient’s earlier use of ramipril therapy provided a longer-term protective effect compared with the later initiation of such therapy. These benefits were consistent regardless of patient risk or ancillary treatments.

Prior to HOPE-TOO, the Heart Outcomes Prevention Evaluation (“HOPE”) trial demonstrated that ramipril reduced the risk of stroke, myocardial infarction, or death from cardiovascular causes in high risk patients 55 years of age or older. The main objective of the HOPE-TOO trial was to evaluate whether the reduction in risk of major cardiovascular events and of new diagnosis of diabetes in patients treated with ramipril during the HOPE trial was maintained with a longer duration of observation.

Charles L. Pamplin, III, M.D., Vice President, Medical Affairs of King stated, “We are very pleased with the results of the HOPE-TOO study which add to the extensive clinical data for our leading product ALTACE. The HOPE-TOO data emphasizes the importance of patients continuing their ALTACE therapy due to the sustained effect in reducing the risk of cardiovascular events and mortality.”

Dr. Pamplin continued, “The HOPE-TOO results also validate the importance of initiating early treatment and the need for continued study of the possible revascularization and metabolic benefits of ALTACE. The currently ongoing Diabetes REduction Assessment with ramipril and rosiglitazone Medication (“DREAM”) trial, a large, international, multicenter, randomized, double- blind, placebo-controlled trial, should determine if ALTACE and/or rosiglitazone reduce the risk for onset of Type II diabetes.”

The HOPE-TOO trial was conducted by the Population Health Research Institute at McMaster University and Hamilton Health Sciences in Hamilton, Ontario, Canada.

Jackie Bosch, project manager and assistant clinical professor at McMaster University said, “Not only were the benefits of ramipril sustained, but the benefits in reducing heart attacks and mortality were further enhanced.”

Dr. Salim Yusuf, co-principal investigator and professor of medicine at McMaster University, said the additional study period was beneficial. “This extension emphasizes that to understand the full benefits or full harm from various prevention or treatment strategies often requires extended observation of patients for several years after the end of trials. The HOPE-TOO results confirm the sustained value of ramipril.”

The Population Health Research Institute conducts research internationally in the areas of prevention and treatment of cardiovascular disease and diabetes. It is currently conducting studies in 66 countries at over 800 study centers.

The HOPE and HOPE-TOO studies were supported by grants from the Canadian Institutes of Health Research, the Heart and Stroke Foundation of Ontario, Aventis Pharmaceuticals, the Natural Source Vitamin E Association, Astra- Zeneca, King Pharmaceuticals and NEGMA.

The investigational DREAM trial is being coordinated by the Canadian Cardiovascular Collaboration based at McMaster University, and is jointly funded by the Canadian Institutes of Health Research, King Pharmaceuticals, Sanofi-Aventis, Glaxo SmithKline, and Wyeth Pharmaceuticals. The study commenced in July 2001 and has completed randomization of 5,269 pre-diabetic patients with impaired glucose tolerance at 191 study centers in 21 countries worldwide. The completion of the trial is scheduled for 2006.

About ALTACE

ALTACE is marketed by Monarch Pharmaceuticals, Inc., a wholly owned subsidiary of King Pharmaceuticals, and Wyeth Pharmaceuticals in the United States and Puerto Rico pursuant to a co-promotion agreement.

ALTACE is the leading branded ACE inhibitor with a broad spectrum of indications. ALTACE is indicated for the treatment of hypertension. ALTACE has also been shown to reduce the risk of death in stable patients who have demonstrated clinical signs of congestive heart failure within the first few days after sustaining acute myocardial infarction. Based upon the results of the landmark HOPE trial, ALTACE is also indicated in patients 55 years or older at high risk of developing a major cardiovascular event either because of a history of coronary artery disease, stroke or peripheral vascular disease or because of diabetes that is accompanied by at least one other cardiovascular risk factor (hypertension, elevated total cholesterol levels, low HDL levels, cigarette smoking, or documented microalbuminuria), to reduce the risk of stroke, myocardial infarction, or death from cardiovascular causes. ALTACE can be used in addition to other needed treatments (such as antihypertensive, antiplatelet or lipid-lowering therapies).

Prescription ALTACE is not for everyone. ALTACE may cause swelling of the mouth, tongue, or throat, which could cause extremely serious risk and requires immediate medical care. ALTACE may lower blood sugar if taken for diabetes. A physician should be contacted if one experiences symptoms of low blood sugar such as sweating or shakiness. Common side effects include persistent dry cough, dizziness, and light-headedness due to low blood pressure. ALTACE should not be taken during pregnancy, as death or injury to an unborn child may result, or if serious side effects related to previous ACE inhibitors have occurred.

For a copy of the ALTACE prescribing information, please visit http://www.altace.com/.

About King Pharmaceuticals

King, headquartered in Bristol, Tennessee, is a vertically integrated branded pharmaceutical company. King, an S&P 500 Index company, seeks to capitalize on opportunities in the pharmaceutical industry through the development, including through in-licensing arrangements and acquisitions, of novel branded prescription pharmaceutical products in attractive markets and the strategic acquisition of branded products that can benefit from focused promotion and marketing and product life-cycle management.

King Pharmaceuticals, Inc.

CONTACT: James E. Green, Executive Vice President, Corporate Affairs,+1-423-989-8125, or David E. Robinson, Senior Director, Corporate Affairs,+1-423-989-7045, both of King Pharmaceuticals, Inc.

Web site: http://www.kingpharm.com/http://www.altace.com/

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