UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): June 23, 2009 (June 23, 2009)
King Pharmaceuticals, Inc.
(Exact name of registrant as specified in charter)
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Tennessee
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001-15875
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54-1684963 |
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(State or other jurisdiction
of incorporation)
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(Commission
File Number)
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(I.R.S. Employer
Identification No.) |
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501 Fifth Street, Bristol, Tennessee
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37620 |
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(Address of principal executive offices)
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(Zip Code) |
Registrants telephone number, including area code: (423) 989-8000
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy
the filing obligation of the registrant under any of the following provisions (see General
Instruction A.2. below):
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 8.01. Other Events.
King Pharmaceuticals, Inc. (the Company) is party to an exclusive license agreement with
Acura Pharmaceuticals, Inc. (Acura) for the development and commercialization of certain opioid
analgesic products utilizing Acuras Aversion® Technology in the United States, Canada and Mexico.
The agreement provides us with an exclusive license for Acurox® (oxycodone hydrochloride and
niacin) Tablets.
On June 18, 2009, Acura received a communication from the Food and Drug Administration (FDA)
regarding the New Drug Application (NDA) for
Acurox® Tablets, which was granted priority review by
the FDA on February 22, 2009. This communication contained preliminary comments from the FDA
related to its review of the NDA and noted that the comments are subject to change as the review
continues.
Based upon the
proximity of this communication to the June 30, 2009
Prescription Drug User
Fee Act (PDUFA) date for the NDA, management believes that the
Company is unlikely to receive regulatory approval of the NDA on that
date.
FORWARD-LOOKING STATEMENTS
This report contains forward-looking statements which reflect managements current views of future
events and operations, including, but not limited to, statements pertaining to the Companys
expectations regarding the FDAs review of the Companys NDA for Acurox® (oxycodone hydrochloride
and niacin) Tablets. These forward-looking statements involve certain significant risks and
uncertainties, and actual results may differ materially from the forward-looking statements. A
factor which may cause results to differ is dependence on the unpredictability of the duration and
results of the FDAs review of the Companys NDA for Acurox®
(oxycodone hydrochloride and niacin) Tablets. 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 the Companys Form 10-K for the year ended December 31,
2008, and Form 10-Q for the first quarter ended March 31, 2009, which are on file with the U.S.
Securities and Exchange Commission. The Company 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.