BRISTOL, Tenn., March 24 /PRNewswire-FirstCall/ -- King Pharmaceuticals,
Inc. (NYSE: KG) today reported that, in recent communications with the U.S.
Food and Drug Administration ("FDA"), the Company has been informed that the
data from its completed TOPHAT (Treatment of Pediatric Hypertension with
Altace Trial) clinical trial submitted in support of its supplemental New Drug
Application ("sNDA") are insufficient, and the Company believes that, subject
to additional discussions with the FDA, it may be necessary to conduct a
second clinical trial in order to receive an additional six months of
exclusivity beyond patent expiry for the Company's Altace(R) (ramipril)
product. In light of this denial, the Company plans to have further
discussions with the FDA and provide additional supportive analyses. If
necessary, the Company also intends to pursue an additional clinical trial and
meet with the FDA to reach agreement on the design of that trial. Should such
an additional clinical trial be necessary, and provided that the study is
completed and reported to the FDA by the third quarter of 2008 and that the
results meet the FDA's requirements, the Company believes it can satisfy the
applicable regulations and obtain an additional six months of market
exclusivity.
TOPHAT was initiated in response to the FDA's written request for
additional information regarding Altace(R) that may produce health benefits in
pediatric populations. This request was issued in accordance with the
Modernization Act of 1997.
About Altace(R)
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 Company's belief that the FDA may
require King to conduct a second clinical trial to complement the sNDA;
statements pertaining to the Company's plan to share additional analyses with
the FDA; and statements pertaining to the potential for additional market
exclusivity beyond patent expiry 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 Company's ability to successfully design
and complete any required additional clinical trial in connection with the
sNDA that the FDA may require to obtain an additional six months of market
exclusivity beyond patent expiry for Altace(R); dependence on whether the FDA
grants an additional six months of market exclusivity beyond patent expiry
pursuant to the Modernization Act of 1997; 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 ended December 31, 2005 which is 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.
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, Inc.
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