BRISTOL, Tenn., Jan. 5 /PRNewswire-FirstCall/ -- King Pharmaceuticals, Inc. 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.
King Pharmaceuticals, Inc.
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
Web site: http://www.kingpharm.com/
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