BRISTOL, Tenn., Jan. 29 /PRNewswire-FirstCall/ -- King Pharmaceuticals,
Inc. (NYSE: KG) reported today the publication online of the results of a
Phase II clinical trial involving binodenoson in Circulation, a journal of the
American Heart Association ("AHA"). The report is entitled Randomized,
Controlled Dose-Ranging Study of the Selective Adenosine A2A Receptor Agonist
Binodenoson for Pharmacologic Stress as an Adjunct to Myocardial Perfusion
Imaging. Circulation is a leading cardiology publication that publishes peer-
reviewed reports on clinical and laboratory research relevant to
cardiovascular disease. The report is available at Circulation's
website, http://circ.ahajournals.org/ . The paper was accepted as a rapid
track publication, which designates this information as an important medical
advance, thus appearing online prior to publication in the February 3, 2004
issue of the journal.
Michael K. Jolly, Pharm.D., Executive Vice President, Research and
Development, of King, stated, "We are very pleased with the publication of our
promising Phase II clinical data relating to the safety and efficacy of King's
binodenoson product in the AHA journal Circulation. The publication of this
study in AHA's premier cardiology journal reflects well on the high scientific
standards that we apply to our R&D programs, the importance of binodenoson as
a therapeutic advance, and King's potential for bringing promising new
products to market."
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. By
targeting the adenosine A2A receptor subtype, binodenoson appears to detect
myocardial ischemia as well as adenosine, while minimizing side effects like
heart block, dyspnea, and chest pain."
King commenced last month, December 2003, the pivotal Phase III clinical
trial program involving the Company's binodenoson product. Dr. Christopher
Brown, MD, a cardiologist with The Heart Group located in Mobile, Alabama,
enrolled and dosed the first patient in the Phase III clinical trial.
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 binodenoson as a potential future
successful cardiac pharmacologic stress SPECT imaging agent; 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
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
http://circ.ahajournals.org
CONTACT:
James E. Green, Executive Vice President,
Corporate Affairs of King Pharmaceuticals, Inc., +1-423-989-8125
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