BRISTOL, Tenn., Oct. 24 /PRNewswire-FirstCall/ -- King Pharmaceuticals,
Inc. (NYSE: KG) announced today that the American Heart Association ("AHA")
has accepted three abstracts featuring data from the Phase II clinical studies
involving binodenoson for presentation at the American Heart Association's
Scientific Sessions, the world's largest convention for scientists and
healthcare professionals devoted to cardiovascular disease and stroke, to be
held in Orlando, Florida, on November 9-12, 2003. Binodenoson is an adenosine
A2A receptor agonist that King is developing for cardiac pharmacologic stress-
imaging. Oral presentations relating to two of the accepted abstracts are
scheduled for the session entitled "Pharmacologic Agents, Perfusion and
Prognosis" to be held on Wednesday, November 12th from 8:30 a.m. to 11:45 am,
ET in Room 312 of the Orange County Convention Center. The two oral
presentations are entitled:
SPECT Image Concordance Between the New Selective Adenosine A2A Receptor
Agonist, Binodenoson, and Adenosine: A Multicenter, Randomized, Dose-
Selection Trial; and
Hemodynamic Effects, Reversibility and Tolerability of a Novel Adenosine
A2A Receptor Agonist for Pharmacologic Stress Testing.
A poster presentation of a third abstract, entitled "Safety of a New
Selective Adenosine A2A Receptor Agonist, Binodenoson, Compared to Adenosine,"
will be available during a session entitled "Advances in Cardiovascular
Nuclear Medicine" on Sunday, November 9th from 8:30 am to 5:00 pm, in the
Orange County Convention Center, Hall A.
Michael K. Jolly, Pharm. D., Executive Vice President, Research and
Development, of King, stated, "We are very excited about our forthcoming
opportunity to present our promising data relating to the safety and efficacy
of King's binodenoson product at AHA, the nation's top heart meeting. Results
from our Phase I and Phase II trials are laying the groundwork for two pivotal
Phase III trials involving binodenoson, the first of which should commence
later this year." Dr. Jolly continued, "The acceptance of our abstracts
regarding the data from the Phase II trials involving binodenoson for
presentation at AHA, the nation's preeminent heart meeting, reflects well on
the importance of binodenoson 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."
Two of the three presentations at AHA will report in detail the results of
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 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.
The third presentation will report the results of MRE0470P-202 and -205,
two interventional cardiology studies that demonstrated differences between
the coronary vasodilatory and hemodynamic responses to three IV bolus doses of
binodenoson. These studies, which were conducted at 18 U.S. hospitals,
facilitated King's selection of the single binodenoson dose to be administered
to patients in the planned Phase III clinical trials.
King, headquartered in Bristol, Tennessee, is a vertically integrated
pharmaceutical company that develops, manufactures, markets, and sells branded
prescription pharmaceutical products. 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 Phase III trial involving binodenoson
that is anticipated to begin during the fourth quarter of 2003; statements
pertaining to plans to present binodenoson abstracts at the AHA meeting; and
statements pertaining to the effectiveness 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 King's ability to timely initiate the Phase III trial involving binodenoson
scheduled to begin during the fourth quarter of 2003; dependence on whether
the binodenoson abstracts are presented at the AHA meeting as planned;
dependence on the continued successful development of binodenoson; 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 second quarter ended June 30, 2003,
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.
SOURCE King Pharmaceuticals, Inc.
 back to top
Related links:
http://www.kingpharm.com
CONTACT:
James E. Green, Executive Vice President,
Corporate Affairs, of King Pharmaceuticals, Inc., +1-423-989-8125
|
