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King Pharmaceuticals Reports FDA Acceptance of Altace(R) Supplemental New Drug Application for Delaying the Progression of Chronic Kidney Disease in Hypertensive, Non-Diabetic Patients

Posted on: Thursday, 22 September 2005, 18:00 CDT

BRISTOL, Tenn., Sept. 22 /PRNewswire-FirstCall/ -- King Pharmaceuticals, Inc. reported today that the U.S. Food and Drug Administration ("FDA") accepted for filing the Company's supplemental new drug application ("sNDA") seeking a new indication for Altace(R) (ramipril). Specifically, King is seeking approval of an indication for Altace(R) as initial therapy in a multi-drug regimen to delay the progression of chronic kidney disease in hypertensive patients with non-diabetic kidney disease.

Charles L. Pamplin, III, M.D., Vice President, Medical Affairs of King, stated, "This exemplifies our commitment to addressing important healthcare concerns. Reducing the progression of chronic kidney disease will not only improve the quality of life for many patients suffering from chronic kidney disease and end-stage renal disease, but will also reduce the significant healthcare burden associated with these ailments."

King is seeking an expansion of the label for this indication based on a compilation of data from two, randomized clinical trials: the AASK (African American Study of Kidney Disease and Hypertension) trial(1) and the REIN (Ramipril Efficacy In Nephropathy) trial.(2,3) The AASK trial, a randomized U.S. clinical study, evaluated the efficacy of Altace(R) and two other treatment regimens in 1094 African Americans with hypertension, using clinical outcomes of changes in glomerular filtration rate ("GFR"), slowing the progression of end-stage renal disease, and mortality. The REIN trial, which was conducted in a predominantly Caucasian population, evaluated the effect of Altace(R) on the progression of kidney disease as measured by slowing the decline in GFR and reducing the incidence of end-stage renal disease.

Hypertension is the second leading cause of end-stage renal disease as reported by the United States Renal Data System (USRDS)(4), with African Americans six times more likely to develop end-stage renal disease from hypertension than Whites.(5) According to the National Kidney Foundation, approximately 20 million Americans - 1 in 9 U.S. adults - suffer from chronic kidney disease and 20 million more are at increased risk.(6) The annual cost of end-stage renal disease, which involves dialysis and, at times, kidney transplants, is estimated to be approximately $25 billion.(4)

Earlier this month, King reported the publication of the results of the Heart Outcomes Prevention Evaluation - The Ongoing Outcomes ("HOPE-TOO") 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. The HOPE-TOO results demonstrated the sustained effect of Altace(R) in reducing the risk of cardiovascular events for more than seven years.

About Altace(R)

Altace(R) 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(R) is the leading branded ACE inhibitor with multiple indications. Altace(R) is indicated for the treatment of hypertension. Altace(R) 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(R) 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(R) can be used in addition to other needed treatments (such as antihypertensive, antiplatelet or lipid-lowering therapies).

Prescription Altace(R) is not for everyone. Altace(R) may cause swelling of the mouth, tongue, or throat, which could cause extremely serious risk and requires immediate medical care. Altace(R) 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(R) 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(R) 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.

Forward-looking Statements

This release contains forward-looking statements which reflect management's current views of future events and operations, including, but not limited to, statements pertaining to the filing of a sNDA seeking a new indication for Altace(R). Forward-looking statements involve certain significant risks and uncertainties, and actual results may differ materially from the forward-looking statements. Some important factors which may cause actual results to differ materially from the forward-looking statements include: dependence on the results of the FDA's review of the sNDA; dependence on King's compliance with FDA and other government regulations that relate to the Company's business; and changes in federal and state laws and regulations. Other important factors that may cause actual results to differ materially from the forward-looking statements are discussed in the "Risk Factors" section and other sections of King's Form 10-K for the year ending December 31, 2004 and Form 10-Q for the second quarter ending June 30, 2005, which are on file with the SEC. King does not undertake to publicly update or revise any of its forward-looking statements even if experience or future changes show that the indicated results or events will not be realized.

(1) Wright JT Jr, Bakris G, Greene T, Agodoa LY, Appel LJ, Charleston J, et al; African American Study of Kidney Disease and Hypertension Study Group. Effect of blood pressure lowering and antihypertensive drug class on progression of hypertensive kidney disease: results from the AASK trial. JAMA 2002 Nov 20;288(19):2421-31. (2) The GISEN Group (Gruppo Italiano di Studi Epidemiologici in Nefrologia). Randomised placebo-controlled trial of effect of ramipril on decline in glomerular filtration rate and risk of terminal renal failure in proteinuric, non-diabetic nephropathy. Lancet 1997 Jun 28;349:1857-63. (3) Ruggenenti P, Perna A, Gherardi G, Garini G, Zoccali C, Salvadori M, et al. Renoprotective properties of ACE-inhibition in non-diabetic nephropathies with non-nephrotic proteinuria. Lancet 1999 Jul 31;354(9176):359-64. (4) U.S. Renal Data System: Excerpts from the USRDS 2004 Annual Data Report. Am J Kidney Dis 2005;45 (Suppl 1). Available at http//:http://www.usrds.org/ (5) Rahman M, Douglas JG, Wright JT Jr. Pathophysiology and treatment implications of hypertension in the African-American population. Endocrinol Metab Clin North Am 1997;26(1):125-44. (6) National Kidney Foundation http://www.kidney.org/

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

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

Company News On-Call: http://www.prnewswire.com/comp/120319.html

Source: PRNewswire-FirstCall

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