BRISTOL, Tenn., Sept. 22 /PRNewswire-FirstCall/ -- King Pharmaceuticals,
Inc. (NYSE: KG) 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//: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
SOURCE King Pharmaceuticals, Inc.
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Related links:
http://www.kingpharm.com
http://www.altace.com
Company News On-Call:
http://www.prnewswire.com/comp/120319.html
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
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