BRISTOL, Tenn., March 5 /PRNewswire-FirstCall/ -- King Pharmaceuticals,
Inc. (NYSE: KG) announced today the commencement of the Phase II clinical
trial program for the development of an extended release formulation of
Sonata(R) (zaleplon), a nonbenzodiazepine treatment for insomnia. The Phase
II clinical trial program is designed to select the most effective extended
release formulation of Sonata(R) utilizing Elan Corporation plc's commercially
proven Spheroidal Oral Drug Absorption System ("SODAS") as the drug delivery
technology.
Jefferson J. Gregory, Chairman and Chief Executive Officer of King,
stated, "We are pleased to announce the initial dosing of the first patients
in the Phase II clinical trial program for the development of an extended
release formulation of Sonata(R)." Mr. Gregory added, "With U.S. patent
coverage that extends to 2018, the extended release formulation should
establish Sonata(R) as a long-term cornerstone product for our Company.
Moreover, this development program should provide us with the opportunity to
procure additional patents potentially covering, among other things, unique
biopharmaceutical characteristics and methods-of-use related to the extended
release formulation of Sonata(R)."
The prescription insomnia market equaled approximately $2.0 billion in the
U.S. during 2003 and is expected to grow to over $3.5 billion by 2008.
Michael K. Jolly, Pharm. D., Executive Vice President, Research and
Development, of King, commented, "The goal of the Phase II clinical trial
program is to determine which new formulation is the most efficacious for the
purpose of increasing total sleep time and reducing any potential for
premature awakenings, while continuing to build upon the quick onset profile
currently available in the immediate release formulation of Sonata(R)."
About King Pharmaceuticals
King, headquartered in Bristol, Tennessee, is a vertically integrated
pharmaceutical company that develops, manufactures, markets, and sells branded
prescription pharmaceutical products. 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.
About Sonata(R)
Sonata(R) is indicated for short-term insomnia treatment. Although
Sonata(R) improved sleep time from baseline in clinical trials, it has not
been shown to increase total time slept or decrease awakenings versus placebo.
Hypnotics should generally be limited to 7-10 days use, and reevaluation of
patients is recommended if hypnotics are taken more than 2-3 weeks. Sonata(R)
prescriptions should not exceed a one-month supply. Until patients know how
they will react to sleep agents, they should not engage in activities
requiring mental alertness or motor coordination (e.g. driving or operating
machinery) after taking Sonata(R) or any sleep agent. Psychomotor functions
may be impaired for up to 4 hours. In clinical trials, the most common side
effects were headache, dizziness, and somnolence. As with any
sedative/hypnotic, abrupt treatment discontinuation can produce signs and
symptoms of withdrawal and rebound insomnia.
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 potential of an extended release
formulation of Sonata(R) to significantly expand opportunities for the product
in the insomnia market; statements pertaining to the potential of an extended
release formulation of Sonata(R) to serve as a long-term cornerstone product
of the Company; statements pertaining to the potential of the Sonata(R)
extended release Phase II clinical trial program to provide King with the
opportunity to procure additional patents covering, among other things, unique
biopharmaceutical characteristics and methods-of-use related to the extended
release product; and statements pertaining to the anticipated growth potential
of the insomnia market. 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 successful implementation and
execution of King's marketing strategies for the immediate release formulation
of Sonata(R); dependence on the ability of the Company's dedicated field sales
force representatives to successfully market Sonata(R); dependence on King's
ability to maintain effective patent protection for Sonata(R); dependence on
King's ability to maintain and/or establish effective patent protection for
potential new formulations of Sonata(R); dependence on the successful
development of an extended release formulation of Sonata(R); 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 an extended release formulation of Sonata(R);
dependence on the availability and cost of raw materials; dependence on the
potential effect on sales of Sonata(R) as a result of the potential
development and approval of a generic substitute for the product or other new
competitive 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 capacity 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
Company News On-Call:
http://www.prnewswire.com/comp/120319.html
CONTACT:
James E. Green, Executive Vice President,
Corporate Affairs of King Pharmaceuticals, Inc., +1-423-989-8125
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