Phase II Clinical Trial Program Planned to Begin Before the End of April 2004
BRISTOL, Tenn., Feb. 3 /PRNewswire-FirstCall/ -- King Pharmaceuticals,
Inc. (NYSE: KG) announced today that the Company's Investigational New Drug
("IND") Application for an extended release formulation of Sonata(R)
(zaleplon), a nonbenzodiazepine treatment for insomnia, has been allowed by
the U.S. Food and Drug Administration ("FDA"). The Phase II clinical trial
program, designed to select the most effective extended release formulation of
Sonata(R) utilizing the commercially proven drug delivery technology of Elan
Corporation plc, is anticipated to begin before the end of April 2004.
Jefferson J. Gregory, Chairman and Chief Executive Officer of King,
stated, "This is an important step forward for King Pharmaceuticals. The
successful development of an extended release formulation of Sonata(R), along
with the new promotional campaign planned for our immediate release
formulation of this product, should well-position the Sonata(R) brand within
the growing insomnia market." Mr. Gregory explained, "The immediate release
formulation of Sonata(R) is currently a very effective treatment for insomnia,
particularly in those patients who experience difficulty with sleep onset. We
believe that the extended release formulation of Sonata(R), once approved,
will enable us to significantly expand upon our opportunities within the
insomnia market. With U.S. patent coverage that extends to 2018, the extended
release formulation should position 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)."
Mr. Gregory added, "The FDA's allowance of this IND and the planned
commencement of the Sonata(R) extended release Phase II clinical trial program
are evidence of our ability to work productively with Elan for the purpose of
achieving our shared goals for this project. We are very eager to grow our
participation in this large market and believe we currently offer one of the
best products for patients who suffer from insomnia."
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.
Wallace B. Mendelson, M.D., Professor of Psychiatry and Clinical
Pharmacology and former Director of the Sleep Research Laboratory at the
University of Chicago, commented, "This is a very exciting advance for future
treatment options for patients that suffer from insomnia. A product that
maintains the quick onset of action and safety of the immediate release
formulation of Sonata(R), while extending the efficacy of the drug to a
broader range of patients with insomnia, should be very well received by the
medical community."
Michael K. Jolly, Pharm. D., Executive Vice President, Research and
Development, of King, said, "We are very pleased with the allowance of the IND
and excited to begin the Sonata(R) Phase II clinical trial program. The goal
of the Phase II trial 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)."
Dr. Jolly continued, "In connection with our acquisition of Elan's primary
care business last year, which included Sonata(R), King and Elan entered into
an agreement whereby Elan agreed to work with our Company to continue Elan's
ongoing development of new formulations of Sonata(R), which included an
extended release formulation. After evaluating several drug delivery
technologies, we have selected Elan's Spheroidal Oral Drug Absorption System
("SODAS") technology as the most promising for the purpose of developing a
safe and effective extended release formulation of Sonata(R). The SODAS
technology, which incorporates Elan's proprietary multiparticulate pulsatile
system, will utilize uniform spherical beads containing zaleplon, the active
ingredient in Sonata(R), plus excipients coated with product-specific
modified-release polymers." Dr. Jolly further emphasized, "This versatile
delivery technology applied to zaleplon should provide a unique
biopharmaceutical profile leading to a wide variety of additional potential
patents covering the extended 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 vs. 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 1-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 plan to begin the Sonata(R) extended
release Phase II clinical trial program before the end of April 2004;
statements pertaining to the ability of the planned promotion of the current
formulation and the development of an extended release formulation of
Sonata(R) to well-position the Sonata(R) brand in the growing insomnia market;
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 development and implementation of
successful marketing strategies for 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.
 back to top
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
|
