BRISTOL, Tenn., Oct. 10 /PRNewswire-FirstCall/ -- King Pharmaceuticals,
Inc. (NYSE: KG) today updated the progress of the Company's pending
applications for U.S. patents concerning its FDA-approved new formulation of
Levoxyl(R) (levothyroxine sodium tablets, USP). The U.S. Patent and Trademark
office has already published some of these applications and all applications
should be published within the next few weeks. The Company anticipates that
pending patents relating to King's new formulation of Levoxyl(R) should issue
during 2003, potentially during the first half of the year.
(Logo: http://www.newscom.com/cgi-bin/prnh/20010125/KGLOGO )
During 2001 and early 2002, the Company filed with the U.S. Patent and
Trademark Office in excess of 20 applications for patents concerning the
Company's FDA-approved new formulation of Levoxyl(R). The pending patent
applications generally cover, among other things, formulation methodologies
and equipment, formulation technologies, biopharmaceutical characteristics,
drug delivery systems, and methods-of-use.
Jefferson J. Gregory, Chairman and Chief Executive Officer of King,
stated, "The examination of the pending patent applications is proceeding as
expeditiously as possible. Based on the progress made to date, we believe
patents related to our new formulation of Levoxyl(R) could potentially issue
during the first half of 2003. Furthermore, we believe the patents, once
issued, should protect Levoxyl(R) from generic competition and provide the
product with long-term exclusivity."
King also today reiterated its determination that the continued
exclusivity of the Company's largest product, Altace(R), is protected by a
composition of matter patent that does not expire until October 2008. The
Company is privy to the conclusions of well-qualified patent counsel who have
reviewed the patents related to Altace(R) and concluded that the 2008
composition of matter patent should prove clearly enforceable if ever
challenged. Specifically, the opinion of one of the largest law firms in the
U.S. specializing exclusively in securing, protecting, and commercializing
intellectual property rights concludes that King can exclude others from
manufacturing, importing, selling, offering to sell or using ramipril, the
active ingredient in Altace(R), thru October 29, 2008. Moreover, King is not
aware of any present intent to challenge the 2008 patent. If such a challenge
ever arises, the Company intends to aggressively and, it believes,
successfully defend against any such challenge.
Commenting on the current market for acquisitions in the pharmaceutical
industry, Mr. Gregory said, "The market for acquisitions is presently very
strong. Moreover, King is currently involved in serious discussions with
respect to numerous potential acquisition opportunities." Mr. Gregory added,
"With over $1 billion in cash and available capacity under our revolving
credit facility, I believe we are well positioned to continue the successful
execution of our proven acquisition growth strategies."
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 timing of the publishing and issuance
of patents related to Levoxyl(R), statements pertaining to the effectiveness
of potential patents related to Levoxyl(R) to protect the product from generic
competition and provide it with long-term exclusivity, statements pertaining
to the effectiveness of the composition of matter patent related to Altace(R)
to protect the product from generic competition and provide it with
exclusivity thru October 29, 2008, King's ability to successfully defend any
challenge to the 2008 composition of matter patent related to Altace(R),
statements pertaining to potential acquisition opportunities, and statements
pertaining to King's continued successful execution of the Company's
acquisition growth strategies. 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 King's ability to timely
obtain and, if issued, maintain effective patent protection for Levoxyl(R),
dependence on whether the U.S. Patent and Trademark Office issues patents
related to Levoxyl(R) during 2003, and particularly during the first half of
2003, dependence on whether a generic for Levoxyl(R) is approved prior to
issuance of the patents related to Levoxyl(R), dependence on the
enforceability of the Altace(R) composition of matter patent that expires in
October 2008, dependence on King's ability to maintain effective patent
protection and exclusivity for Altace(R) and successfully defend against any
potential attempt to challenge the enforceability of the Altace(R) composition
of matter patent that expires in October 2008, dependence on King's ability to
prevent the introduction of generic competition for Altace(R) prior to the
expiration of the Altace(R) composition of matter patent on October 29, 2008,
dependence on the accuracy of opinions of counsel regarding the enforceability
of the 2008 composition of matter patent related to Altace(R), dependence on
King's ability to successfully execute the Company's acquisition growth
strategies, dependence on our compliance with government regulations that
relate to our business, and dependence on changes in general economic and
business conditions, changes in current pricing levels, 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, 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, +1-423-989-8125
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