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 Acura's
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 management's
current views of future events and operations, including, but not limited to,
statements pertaining to the Company's expectations regarding the FDA's review
of the Company's 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 FDA's review of the
Company's 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 Company's 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.