BRISTOL, Tenn., Jan. 5 /PRNewswire-FirstCall/ -- King Pharmaceuticals,
Inc. (NYSE: KG) announced today that it has initiated the Company's Phase II
clinical trial program evaluating the safety and efficacy of its topical
investigational drug MRE0094 in patients with chronic, neuropathic, diabetic
foot ulcers.
"We are very excited about the potential of MRE0094 as a safe and
effective treatment for chronic, neuropathic, diabetic foot ulcers. During
the course of our Phase I study in patients with this condition, we observed
no safety issues related to MRE0094 and noted positive effects on the rate of
wound closure," stated Michael K. Jolly, Pharm.D., Executive Vice President,
Research and Development, of King. "MRE0094 is a novel, adenosine A2A
receptor agonist that favorably affects the inflammation associated with these
ulcers by regulating the response of inflammatory cells and mediators, and by
enhancing the tissue proliferation phase of wound healing. By virtue of these
various mechanisms including endothelial cell proliferation and migration,
MRE0094 promotes tissue remodeling."
Dr. Jolly noted, "Diabetes is a major U.S. health concern affecting over
6% of the population. The incidence of diabetes is increasing at a rate of
approximately 1.3 million new cases diagnosed per year. With the increasing
prevalence of diabetes, the neuropathic, diabetic 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 neuropathic foot ulcers are
often prolonged by infection, gangrene, and lower extremity amputation."
Chronic, neuropathic, diabetic foot ulcers are a part of the wound healing
market which is estimated at greater than $3 billion in the United States.
The U.S. Food and Drug Administration has not yet evaluated the safety or
efficacy of MRE0094.
About King Pharmaceuticals
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.
Forward-looking Statements
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 MRE0094 Phase II clinical trial
program and the drug's potential. 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
actual results to differ materially from the forward-looking statements
include: dependence on the continued successful development of MRE0094,
including the results of the Phase II clinical trials; 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 King's compliance with FDA and other
government regulations that relate to the Company's business; and changes in
federal and state laws and regulations. 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 ending December 31, 2004 and Form 10-Q for the third quarter
ended September 30, 2005, 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.
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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, +1-423-989-8125, or David E. Robinson, Senior
Director, Corporate Affairs, +1-423-989-7045, both of King
Pharmaceuticals
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