BRISTOL, Tenn., Dec. 5 /PRNewswire-FirstCall/ -- King Pharmaceuticals,
Inc. (NYSE: KG) announced today the commencement of the Phase III clinical
trial program involving binodenoson. Binodenoson is an adenosine A2A receptor
agonist that King is developing for cardiac pharmacologic stress SPECT
imaging, a procedure used to diagnose the presence and severity of coronary
artery disease. The initial dosing of patients participating in the trial is
scheduled to begin later today.
Michael K. Jolly, Pharm. D., Executive Vice President, Research and
Development, of King, stated, "We are very pleased to report that we are
commencing our international, multi-center, double blind, controlled Phase III
clinical trial program involving King's binodenoson product. This program is
designed to provide pivotal clinical evidence of the safety and efficacy of
binodenoson, and to confirm the positive results that were evident in the
Phase II clinical trials involving the drug. We presented the data from our
successful Phase I and Phase II clinical trials involving binodenoson at
meetings of the American Heart Association and American Society of Nuclear
Cardiology earlier this year."
Dr. Jolly observed, "Approximately 3 million pharmacologic stress tests
are performed in the United States each year to diagnose heart disease in
patients who cannot perform traditional exercise stress tests. Adenosine and
dipyridamole are the current agents of choice to achieve the coronary
vasodilation necessary for cardiac imaging in the United States, but these
drugs do not distinguish between the four subtypes of adenosine receptors. Our
Phase II clinical trials showed that by targeting the adenosine A2A receptor
subtype, binodenoson appears to detect myocardial ischemia as well as
adenosine, and produces fewer and less severe side effects like heart block,
dyspnea and chest pain than adenosine and dipyridamole. Unlike the currently
used drugs, which are administered over 4 to 6 minutes, binodenoson will be
given as an IV bolus dose. This advantage, coupled with the improved safety
profile, promises to make these diagnostic tests safer for patients and easier
and more efficient for physicians to administer."
Phase II clinical trials involving binodenoson included MRE0470P-206, a
Phase II, multi-center, randomized, single-blind, two-arm crossover dose-
selection study that enrolled 240 patients with high pretest likelihood for
coronary artery disease ("CAD") or known and symptomatic CAD. All patients
underwent, in random sequence, a standard pharmacologic stress test with
adenosine, and a second, single-blind, pharmacologic stress test with one of
four randomly selected doses of binodenoson. Safety, tolerability, and
pharmacologic stress SPECT image concordance comparisons between binodenoson
and adenosine were examined. There was good to excellent image concordance
with all four binodenoson doses and adenosine. Patients reported fewer and
less severe side effects, including chest pain, shortness of breath, and
flushing during the binodenoson procedure than they did during the adenosine
procedure. None of the patients experienced A-V block with binodenoson,
compared to an incidence of 3% with adenosine. The incidence and the
intensity of side effect reductions using binodenoson were dose-related.
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.
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 scheduled initial dosing of patients
participating in the Phase III clinical trial program involving binodenoson;
the pivotal evidence of the safety and effectiveness of binodenoson that the
Phase III clinical trial program is designed to provide; and the promising
potential differentiating attributes of binodenoson. These 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 results to differ include: dependence on
whether the initial dosing of patients participating in the Phase III clinical
trial program involving binodenoson proceeds as planned; dependence on the
continued successful development of binodenoson and the results of the Phase
III clinical trial program; dependence on the unpredictability of the duration
and results of the U.S. Food and Drug Administration ("FDA") review of any
Investigational New Drug Application and New Drug Application relating to
binodenoson; dependence on our compliance with FDA and other government
regulations that relate to our business; and dependence on changes in general
economic and business conditions, changes in federal and state laws and
regulations, and manufacturing capacity constraints. 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, 2002 and Form 10-Q for the
third quarter ended September 30, 2003, which are on file with the U.S.
Securities and Exchange Commission. 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
Company News On-Call:
http://www.prnewswire.com/comp/120319.html
CONTACT:
James E. Green, Executive Vice President,
Corporate Affairs, King Pharmaceuticals, Inc., +1-423-989-8125
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