BRISTOL, Tenn., Jan. 13 /PRNewswire-FirstCall/ -- King Pharmaceuticals,
Inc. (NYSE: KG) announced today the completion of the dosing of the initial
concentration of MRE0094 in the Company's ongoing Phase I clinical trial
program evaluating the safety of the drug in patients. MRE0094 is an
investigational drug for the topical treatment of chronic diabetic neuropathic
foot ulcers.
Michael K. Jolly, Pharm.D., Executive Vice President, Research and
Development, of King, stated, "We are very excited about the potential of
MRE0094 as an effective treatment for chronic diabetic neuropathic foot
ulcers. MRE0094, an adenosine A2A receptor agonist, is designed to utilize a
novel approach to treating this condition by concentrating on the inflammation
associated with such foot ulcers." Dr. Jolly explained, "Adenosine A2A
receptor agonists have been shown to promote wound closure in mice and
diabetes-induced rats by regulating the response of inflammatory cells and
mediators, promoting tissue formation through various mechanisms including
endothelial cell proliferation and migration, and promoting tissue
remodeling."
Dr. Jolly noted, "Diabetes is a major U.S. health concern affecting nearly
6% of the population, or 16 million people. The incidence of diabetes is
increasing at a rate of approximately 800,000 new cases diagnosed per year.
With the increasing prevalence of diabetes, the diabetic neuropathic foot
ulcer has become a major physical, emotional, and economic burden affecting
patients, families, caregivers, and health systems. Approximately 15% of
diabetic patients will develop foot ulceration during the course of their
disease." Dr. Jolly added, "Hospital admissions of diabetic patients with
foot ulcers are often prolonged by infection, gangrene, and lower extremity
amputation. These admissions account for more in-hospital days than any other
complication of diabetes."
Chronic diabetic foot ulcers represent a significant portion of the wound
healing market which is estimated at greater than $3 billion in the United
States. The Phase II clinical trial program involving MRE0094 is currently
anticipated to commence in the first-half of 2005.
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 development of MRE0094 as an
effective treatment for chronic diabetic neuropathic foot ulcers, including
the planned commencement of the Phase II clinical trial program involving the
drug in 2005. 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
MRE0094, including the results of the planned clinical trials involving the
compound that are intended to demonstrate its safety and efficacy as a
treatment for chronic diabetic neuropathic foot ulcers; 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 MRE0094; 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 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
CONTACT:
James E. Green, Executive Vice President,
Corporate Affairs of King Pharmaceuticals, Inc., +1-423-989-8125
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