BRISTOL, Tenn., Oct. 30 /PRNewswire-FirstCall/ -- King Pharmaceuticals,
Inc. (NYSE: KG) announced today the receipt of an approvable letter for
Intal(R) HFA (cromolyn sodium) from the U.S. Food and Drug Administration
("FDA"). Intal(R) HFA, a new inhaler formulation of King's currently marketed
product Intal(R) (cromolyn sodium) for the long-term management of asthma,
utilizes the environmentally friendly propellant hydrofluoroalkane ("HFA").
Jefferson J. Gregory, Chairman and Chief Executive Officer of King,
stated, "Intal(R) HFA is an important product line extension. With a patent in
the United States until September 2017, Intal(R) HFA provides us with a long-
term exclusive respiratory product with positive differentiating attributes
which include its unique mechanism of action and excellent safety profile, the
latter of which is extremely important for pediatric patients and in other
patient sub-populations for whom safety is a particular concern."
Mr. Gregory noted, "The approvable letter provides that final approval for
the New Drug Application ("NDA") covering Intal(R) HFA is subject to
addressing certain FDA comments solely pertaining to the chemical,
manufacturing and controls section of the New Drug Application ("NDA")
covering the product. We anticipate that these comments can be adequately
addressed in a timeframe that would potentially allow for final FDA approval
of the NDA for Intal(R) HFA during the second half of 2004."
About King Pharmaceuticals
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 Intal(R) HFA providing King with a long-
term exclusive product; statements relating to plans to address comments of
the FDA pertaining to the NDA for Intal(R) HFA; and statements pertaining to
the anticipated FDA approval of the NDA for Intal(R) HFA during the second
half of 2004. 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 whether the FDA's comments relating to the NDA
for Intal(R) HFA are timely and adequately addressed; dependence on the
unpredictability of the duration and results of the FDA review of the NDA
relating to Intal(R) HFA; dependence on King's ability to maintain Intal(R)
HFA as an exclusive product through September 2017; 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 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 second quarter ended June 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
CONTACT:
James E. Green, Executive Vice President,
Corporate Affairs, of King Pharmaceuticals, Inc., +1-423-989-8125
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