BRISTOL, Tenn., Jan. 5 /PRNewswire-FirstCall/ -- King Pharmaceuticals, Inc. announced today the commencement of the Company’s pivotal Phase III clinical trial program evaluating its investigational drug Vanquix(R) as a treatment for acute, repetitive seizures associated with epilepsy. The active ingredient in Vanquix(R) is diazepam, which is administered using King’s auto-injector technology.
Michael K. Jolly, Pharm. D., Executive Vice President, Research and Development, of King, stated, “We are pleased to report the commencement of our pivotal Phase III clinical trial program for Vanquix(R). Currently, there is no commercially available adjunctive injectable therapy, outside of a hospital setting, for the emergency treatment of acute, repetitive epileptic seizures. We believe Vanquix(R) has the potential to effectively address this unmet medical need.”
At present, the only product commercially available for the management of patients with acute, repetitive seizures by a caregiver other than a health care professional is a diazepam rectal gel. This other product requires a patient to retain the gel in the rectum for absorption to occur and may be difficult to administer during a seizure. Furthermore, the rectal route of administration may be considered objectionable to many patients and caregivers, particularly in a public setting. Vanquix(R) is designed to provide a superior means of delivering diazepam to such patients.
Currently marketed products utilizing King’s auto-injector technology include EpiPen(R) (epinephrine), the definitive emergency treatment for severe anaphylaxis. The U.S. Food and Drug Administration has not yet evaluated the safety or efficacy of Vanquix(R).
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 clinical trial program for Vanquix(R) 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 Vanquix(R), including the results of the Phase III 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 Vanquix(R); 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, Inc.
Web site: http://www.kingpharm.com/
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