BRISTOL, Tenn., Jan. 27 /PRNewswire-FirstCall/ -- King Pharmaceuticals,
Inc. (NYSE: KG) announced today that the U.S. Patent and Trademark Office
("PTO") has issued a utility patent, patent no. 6,683,102 ("the '102 Patent"),
pertaining to the Company's U.S. Food and Drug Administration ("FDA") approved
product Skelaxin(R) (metaxalone). Skelaxin(R) is a muscle relaxant, indicated
for the relief of discomforts associated with acute, painful musculoskeletal
conditions and is the only branded prescription pharmaceutical product without
a generic substitute in the muscle relaxant class. The '102 Patent extends
through December 3, 2021.
Jefferson J. Gregory, Chairman and Chief Executive Officer of King,
stated, "We are very excited about the issuance of the '102 Patent which
further strengthens the long-term market potential of our Skelaxin(R) product.
King's Skelaxin(R) patent portfolio, which includes the newly issued '102
Patent and the related U.S. patent no. 6,407,128 ("the '128 Patent"), a
method-of-use patent that also extends through December 3, 2021, is very
comprehensive and covers various therapeutic uses of Skelaxin(R)."
Kyle P. Macione, President of King, added, "As we reported previously, Eon
Labs, Inc. and CorePharma LLC each submitted to the FDA an Abbreviated New
Drug Application ("ANDA") for a generic equivalent to Skelaxin(R) 400mg, with
each application including a paragraph IV certification pertaining to the
Company's '128 Patent covering the product. One of the significant aspects of
today's issuance of the related '102 Patent by the PTO is the fact that the
patent was allowed over allegedly invalidating prior art cited by Eon Labs and
CorePharma in their Paragraph IV submissions pertaining to the '128 Patent."
The '128 Patent is already listed in the FDA's publication entitled
Approved Drug Products with Therapeutic Equivalence Evaluations, commonly
known as the "Orange Book". The Company intends to also list the '102 Patent
in the Orange Book following submission of the necessary information to the
FDA.
As reported previously, patent infringement actions pertaining to King's
'128 Patent covering Skelaxin(R) are pending against both Eon Labs and
CorePharma in the United States District Court for the Eastern District of New
York.
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.
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 '102 Patent further strengthening the
long-term market potential of Skelaxin(R); and statements pertaining to the
Company's plan to list the '102 Patent in the Orange Book. 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 successfully defend against
any potential attempt to challenge the enforceability of the '102 Patent
and/or the '128 Patent, including the current challenges of the '128 Patent by
Eon Labs and CorePharma; dependence on King's ability to maintain effective
patent protection for Skelaxin(R); dependence on King successfully listing the
'102 Patent in the Orange Book; dependence on the development of competing
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 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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