BRISTOL, Tenn., March 12 /PRNewswire-FirstCall/ -- King Pharmaceuticals,
Inc. (NYSE: KG) reported that on March 9, 2004, the Company received a copy of
a letter from the U.S. Food and Drug Administration ("FDA") to all Abbreviated
New Drug Application ("ANDA") applicants for a generic equivalent to the
Company's approved product Skelaxin(R) 400 mg (metaxalone). The letter stated
that ANDA applicants may delete the use listed in the FDA's publication
entitled "Approved Drug Products with Therapeutic Equivalence Evaluations"
(commonly known as the "Orange Book") for U.S. Patent No. 6,407,128 ("the '128
patent") from their product labeling. Skelaxin(R) is a muscle relaxant,
indicated for the relief of discomforts associated with acute, painful
musculoskeletal conditions.
The Company believes that this decision is arbitrary, capricious, and
inconsistent with the FDA's previous position on this issue. Accordingly, King
plans to pursue its administrative and legal remedies. The Company is
currently assessing its legal options and may request the FDA to reinstate its
previous policy on this issue and not approve any ANDAs that delete such use
from their product labeling.
Kyle P. Macione, President of King, stated, "In view of the FDA's previous
position on this issue, we believe this decision by the FDA is inconsistent
and without basis. Because this action is extraordinary and unprecedented
under these circumstances, the FDA should recognize the safety and efficacy
issues surrounding its decision and reinstate its previous policy."
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 Company's plans to pursue its
administrative and legal remedies in response to the FDA's decision to allow
ANDA applicants to delete the use listed in the Orange Book for the 128 Patent
from their product labeling. 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 pursuing the Company's
administrative and legal remedies in response to the FDA's decision to allow
ANDA applicants to delete the use listed in the Orange Book for the 128 Patent
from their product labeling. 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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