BRISTOL, Tenn., Jan. 5 /PRNewswire-FirstCall/ -- King Pharmaceuticals,
Inc. (NYSE: KG) 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.
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, Inc.
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