Plans to Begin Phase I Clinical Trial in Fourth Quarter 2003
BRISTOL, Tenn., Oct. 27 /PRNewswire-FirstCall/ -- King Pharmaceuticals,
Inc. (NYSE: KG) announced today that the Company's Investigational New Drug
("IND") Application for T-62, an investigational drug for the treatment of
neuropathic pain, has been allowed by the U.S. Food and Drug Administration
("FDA"). A Phase I trial to determine the safety of T-62, a new chemical
entity, is now planned to begin during the fourth quarter of 2003. The trial
represents an important step forward in providing patients who suffer from
neuropathic pain with the first orally-administered product in a new class of
investigational agents indicated for the treatment of this prevalent
condition.
Jefferson J. Gregory, Chairman and Chief Executive Officer of King,
stated, "This is an important step forward for King Pharmaceuticals, and an
example of how our long-range strategy in research and development is
strengthening our Company. Although currently available treatments for
neuropathic pain are of limited efficacy, the neuropathic pain market exceeds
$1.7 billion annually and is anticipated to grow at a compound annual growth
rate of over 4% for the next several years according to a published report of
Datamonitor. As more effective products specifically designed to treat this
serious condition are approved, the neuropathic pain market should experience
a significantly expanded rate of growth."
Neuropathic pain refers to pain initially caused by injuries to the nerve
fibers. Symptoms described often include intense burning, shooting or stabbing
pain and a heightened sense of touch, for which traditional pain relievers are
not effective. Typical examples of neuropathic pain include diabetic
neuropathy, post-herpetic neuralgia, and pain associated with spinal cord
injury.
Dr. Michael K. Jolly, Pharm.D., Executive Vice President, Research and
Development, of King, added, "King Pharmaceuticals is a world leader in
adenosine receptor technology, having previously developed two commercialized
adenosine products, Adenoscan(R) (adenosine) and Adenocard(R) (adenosine).
Adenosine, a neurotransmitter that affects the adenosine A1 receptors in the
spinal cord to normalize the pain response, has been shown to be an effective
treatment for neuropathic pain when injected into the spinal cord via
intrathecal administration. T-62 is a new chemical entity that leverages our
tremendous experience in the adenosine technology area. When T-62 is given
orally it enhances the effect of endogenous adenosine in the spinal cord and
should provide effective pain relief by the same mechanism as intrathecally
administered adenosine."
Dr. Jolly noted, "The T-62 program demonstrates our Company's commitment
to expanding our pipeline with promising and innovative new pharmaceutical
products. Neuropathic pain is a serious disorder that impacts the lives of
over 27 million people in the U.S. according to Datamonitor and there is a
substantial unmet medical need for more effective products to treat this
debilitating condition. We believe that T-62 should represent a significant
advancement in filling that need."
About the trial
The initial Phase I trial of T-62 will be a single-center, randomized
double-blind, placebo-controlled evaluation of the safety and pharmacokinetics
of escalating single oral doses of this new chemical entity in healthy adult
subjects.
About King Pharmaceuticals
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 I trial involving T-62 that is
planned to begin during the fourth quarter of 2003; statements pertaining to
the development of T-62 as an effective treatment for neuropathic pain, and
statements pertaining to the growth potential of the neuropathic pain market.
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 I trial
involving T-62 scheduled to begin during the fourth quarter of 2003;
dependence on the continued successful development of T-62, including the
results of the planned clinical trials involving the compound that are
intended to demonstrate its safety and efficacy as a treatment for neuropathic
pain; dependence on the unpredictability of the duration and results of the
FDA review of any Investigational New Drug Application and New Drug
Application relating to T-62; dependence on the development of competing
products; 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 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 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
CONTACT:
James E. Green, Executive Vice President,
Corporate Affairs of King Pharmaceuticals, Inc., +1-423-989-8125
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