King Pharmaceuticals Reports Efficacy of ALTACE® 20mg And Efficacy of a Combination of ALTACE 20mg And Hydrochlorothiazide 25mg For 24-hour Blood Pressure Control

Business Wire, May 20, 2007

BRISTOL, Tenn. -- The following was released on Saturday, May 19 and is being repeated.

King Pharmaceuticals, Inc. (NYSE:KG) reported today that data from its Phase III clinical trial evaluating ALTACE([R]) (ramipril) 20mg and the combination of ALTACE 20mg and hydrochlorothiazide (HCT) 25mg were presented this weekend at the American Society of Hypertension, Inc. (ASH) Twenty-Second Annual Scientific Meeting and Exposition (ASH 2007) in Chicago, Illinois. The clinical trial data showed that ALTACE 20mg resulted in significant reductions in systolic blood pressure (SBP) and diastolic blood pressure (DBP). ALTACE 20mg used in combination with HCT 25mg once daily as measured by a semi-automatic digital blood pressure device (office measurements) resulted in a statistically significant greater reduction of both seated DBP and seated SBP compared to monotherapy with HCT 25mg once daily or ALTACE 20mg once daily in patients with Stage 2 Essential Hypertension defined as blood pressure equal to or greater than 160 mmHg SBP or 100 mmHg DBP.

Data from the trial also showed that ALTACE 20mg monotherapy once daily provide significant reductions in mean 24-hour SBP and DBP of 11.4 mmHg and 6.2 mmHg, respectively. Importantly, as compared to office measurements, statistically significant greater reductions in mean 24-hour blood pressure, as measured by ambulatory blood pressure monitoring, were obtained with the combination therapy. Ambulatory blood pressure measurements have been shown to correlate better than office measurements for predicting adverse effects on end organs such as the kidney, heart, or brain. The safety profile of the combination was consistent with current labeling for the individual monotherapy drugs as approved by the U.S. Food and Drug Administration (FDA).

"As described in the current JNC-7 hypertension treatment guidelines, if SBP is 20 mmHg or DBP is 10 mmHg above a patient's goal, consideration should be given to initiating therapy with two antihypertensive drugs, one of which is usually a thiazide diuretic. In the study, combining ALTACE 20mg with HCT 25mg was significantly better than monotherapy in achieving blood pressure control. Our results also show that the maximum approved dose of 20mg a day of ALTACE was well tolerated and showed significant reductions in systolic and diastolic blood pressure," said Dr. William B. White, Professor and Chief of Hypertension and Clinical Pharmacology at the University of Connecticut Health Center, and the study's lead investigator. "These data provide evidence that ALTACE 20mg monotherapy and the combination of ALTACE 20mg with HCT 25mg provide meaningful clinical blood pressure reductions and 24-hour control."

"We're excited about the results of the study," said Dr. Eric Carter, Chief Science Officer of King. "These data demonstrate the efficacy and tolerability benefits of 20mg of ALTACE, the maximum approved dose, and the benefits of 20mg of ALTACE combined with HCT 25mg for patients who require an antihypertensive agent as well as a diuretic. We plan to submit these data as part of a New Drug Application to the FDA later this year, a major milestone for King Pharmaceuticals."

About the Clinical Trial

The primary endpoint of the trial was designed to demonstrate that the reduction in DBP in patients taking the combination of ALTACE 20mg and HCT 25mg once daily is statistically superior to that achieved in patients taking either monotherapy alone. The trial met the primary endpoint in that DBP reduction is statistically superior (p<0.001) with the combination compared to either monotherapy. The DBP was reduced by 15.5 mmHg with the combination compared to 8.5 mmHg with HCT 25mg and 9.2 mmHg with ALTACE 20mg.

A secondary endpoint of the trial was designed to demonstrate that the reduction in SBP in patients taking the combination of ALTACE 20mg and HCT 25mg once daily is statistically superior to that achieved in patients taking either monotherapy alone. The trial met the secondary endpoint in that SBP reduction is statistically superior with the combination compared to either monotherapy. The SBP was reduced by 18.6 mmHg with the combination compared to 11.5 mmHg with HCT 25mg (p<0.001) and 10.4 mmHg with ALTACE 20mg (p=0.002).

The clinical trial was a randomized, double-blind, double-dummy, parallel-arm, multicenter study evaluating the effects of combining ALTACE 20mg and HCT 25mg once a day versus the monotherapy comparator arms of the component drugs. Patients were treated for eight weeks. A total of 341 patients comprised the intention-to-treat efficacy population. Blood pressure was measured using both a semi-automatic digital blood pressure device and 24-hour ambulatory blood pressure monitor.

A copy of the poster detailing the results of the trial and presented at ASH 2007 is available on King's website at: http://www.kingpharm.com/ashposter.asp.

About ALTACE

ALTACE is the leading branded ACE inhibitor with multiple 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 10mg is also indicated in patients age 55 or over at high risk of developing a major CV 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 CV 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 CV causes. ALTACE can be used in addition to other needed treatments (such as antihypertensive, antiplatelet or lipid-lowering therapies).