BRISTOL, Tenn., Oct. 8 /PRNewswire-FirstCall/ -- King Pharmaceuticals,
Inc. (NYSE: KG) today announced that it has obtained an exclusive license from
BeartownPharma, Inc. to manufacture, promote, market, distribute and sell
Tetrac (tetraiodothyroacetic acid) as a compound for the suppression of
pituitary secretion of thyroid stimulating hormone ("TSH") in the United
States, its territories and possessions, Canada, Mexico, and all countries in
Central America and South America.
(Photo: http://www.newscom.com/cgi-bin/prnh/20010125/KGLOGO )
Tetrac suppresses TSH without producing hyperthyroidism when taken in
combination with normal replacement levels of levothyroxine sodium (T4) such
as King's drug, Levoxyl(R) (levothyroxine sodium tablets, USP). Patients with
well-differentiated thyroid cancer, after undergoing thyroidectomy and
radioiodine therapy, are presently treated with high doses of T4 for the
purpose of suppressing TSH. TSH is a potent stimulator of thyroid growth that
must be suppressed in order to prevent the hormone from stimulating the growth
and progression of residual thyroid cancer and the continued growth of benign
thyroid nodules. High doses of levothyroxine sodium (T4) produce mild
hyperthyroidism and many of the chronic conditions associated with
hyperthyroidism, including frequent cardiac arrhythmias and premature
osteopenia (loss of bone mass). There are approximately 200,000 patients with
diagnosed thyroid cancer in the United States.
The U.S. Food and Drug Administration ("FDA") has granted Orphan Drug
status for Tetrac for the purpose of suppressing TSH in association with
thyroid cancer treatment. This designation will provide Tetrac with seven
years of exclusivity once the product is approved for adjunctive thyroid
cancer treatment and may potentially allow for an accelerated development and
FDA review process. Furthermore, Beartown has filed patent applications
related to Tetrac which should provide the product with additional long-term
exclusivity once the patents issue. As part of the transaction, King has
agreed to pay direct expenses associated with the development of Tetrac for
the purpose of obtaining an indication for adjunctive thyroid cancer
treatment. In the future, King may consider pursuing additional indications
for the product, such as an indication for the treatment of benign thyroid
nodules.
King will pay Beartown a total of approximately $1 million as a license
fee and to cover associated expenses, payable during the fourth quarter of
2002, plus potential payments of up to $1.5 million for certain milestones
that may occur prior to FDA approval of a Tetrac indication for adjunctive
thyroid cancer treatment and up to $7.5 million for certain milestones that
may occur on or after obtaining such FDA approval. Furthermore, King will pay
Beartown during the term of the license a reasonable royalty on net sales in
each country in the territory.
Jefferson J. Gregory, Chairman and Chief Executive Office of King, stated
"We are very pleased to collaborate with Beartown in the development and
potential commercialization of Tetrac. Once approved, this exciting new
product for the treatment of thyroid cancer should strategically complement
our growing line of thyroid products, including our second largest product,
Levoxyl(R)."
King, headquartered in Bristol, Tennessee, is a vertically integrated
pharmaceutical company that manufactures, markets, and sells primarily branded
prescription pharmaceutical products. King, an S&P 500 Index company, seeks to
capitalize on opportunities in the pharmaceutical industry created by cost
containment initiatives and consolidation among large global pharmaceutical
companies. King's strategy is to acquire branded pharmaceutical products and
to increase their sales by focused promotion and marketing and through product
life cycle management.
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 development and potential
commercialization of Tetrac by Beartown and King. 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
Beartown's and King's ability to successfully develop, manufacture, and
potentially market and sell Tetrac, dependence on sales of King's products,
including, in particular, but not limited to, Altace(R) (ramipril),
Levoxyl(R), and Thrombin(R)-JMI (thrombin, topical, bovine, USP), dependence
on King's ability to continue to successfully execute the Company's proven
growth strategies, management of King's growth and integration of its
acquisitions, and the high cost and uncertainty of research, clinical trials,
and other development activities involving pharmaceutical products, including,
but not limited to, Tetrac. 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, 2001 and Form 10-Q for the quarter ended June 30,
2002, which are on file with the 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
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CONTACT:
James E. Green, Vice President, Corporate
Affairs of King Pharmaceuticals, Inc., +1-423-989-8125
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