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
December
23, 2008
Date of Report (Date of earliest event
reported)
___________________________________________________________
ACURA
PHARMACEUTICALS, INC.
(Exact
Name of Registrant as Specified in Charter)
___________________________________________________________
|
State
of New York
|
1-10113
|
11-0853640
|
|
(State
of Other Jurisdiction
|
(Commission
File Number)
|
(I.R.S.
Employer
|
|
of
Incorporation)
|
Identification
Number)
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616
N. North Court, Suite 120
Palatine,
Illinois 60067
(Address
of principal executive offices) (Zip Code)
(847)
705-7709
(Registrant’s
telephone number, including area code)
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
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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))
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|
o
|
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17CFR
240.13e-4(c)
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Item
8.01 Other Events
On December 23, 2008, King
Pharmaceuticals Research and Development, Inc. (“King”), a wholly-owned
subsidiary of King Pharmaceuticals, Inc., exercised an option under the License,
Development and Commercialization Agreement dated as of October 30, 2007 between
King and us, as amended, to license from us a fourth immediate-release opioid
analgesic product utilizing our proprietary Aversion®
Technology and paid us the $3 million exercise price. A press release
issued by us in connection with the option exercise is furnished as Exhibit
99.1.
Item
9.01 Financial Statements and Exhibits
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Exhibit Number
|
Description
|
|
99.1
|
Press
Release of the Registrant dated December 24,
2008.
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SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
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ACURA
PHARMACEUTICALS, INC.
|
|||
|
|
By:
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/s/ Peter Clemens | |
| Peter A. Clemens | |||
| Senior Vice President & Chief Financial Officer | |||
Date:
December 23, 2008
EXHIBIT
INDEX
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Exhibit Number
|
Description
|
|
99.1
|
Press
Release of the Registrant dated December 24,
2008.
|
|
King
Pharmaceuticals Contacts:
James
E. Green, Executive Vice President, Corporate Affairs
423-989-8125
David
E. Robinson, Senior Director, Corporate Affairs
423-989-7045
|
|
Acura
Pharmaceuticals Contact:
Peter
A. Clemens, SVP Investor Relations & CFO
847-705-7709
|
KING
PHARMACEUTICALS EXERCISES OPTION TO LICENSE
FOURTH
OPIOID PRODUCT FROM ACURA PHARMACEUTICALS
--
Opioid Analgesic Product Designed to Deter Abuse --
PALATINE,
ILLINOIS, and BRISTOL, TENNESSEE, December 24, 2008 – Acura Pharmaceuticals,
Inc. (NASDAQ: ACUR) and King Pharmaceuticals, Inc. (NYSE: KG) today announced
that King has exercised its option to license a fourth immediate-release opioid
analgesic product candidate utilizing Acura’s proprietary Aversion®
Technology. In connection with the exercise of its option, King paid
Acura an option exercise fee of $3.0 million. Products utilizing
Aversion®
Technology are designed to deter common methods of prescription drug misuse and
abuse.
Along
with this fourth opioid product candidate, King and Acura are jointly developing
three other opioid analgesic product candidates utilizing Acura’s Aversion®
Technology, including Acurox®
(oxycodone HCl/niacin) Tablets. All of these product candidates have been
licensed by Acura to King pursuant to an October 2007 License, Development and
Commercialization Agreement (the “Agreement”). The Agreement provides King
with an option to
license all opioid analgesic products utilizing Aversion® Technology for
development and commercialization in the United States, Canada and
Mexico.
About
AVERSION®
Technology
Aversion®
Technology is a patented composition of active and inactive ingredients intended
to relieve moderate to severe pain while simultaneously deterring common methods
of prescription drug abuse, including intravenous injection of dissolved
tablets, nasal snorting of crushed tablets and intentional swallowing of
excessive numbers of tablets.
About
King Pharmaceuticals, Inc.
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 that complement the Company's focus in
specialty-driven markets, particularly neuroscience, hospital and acute care.
King strives to be a leader and partner of choice in bringing innovative,
clinically-differentiated medicines and technologies to market.
About
Acura Pharmaceuticals, Inc.
Acura
Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in research,
development and manufacture of innovative Aversion® (abuse
deterrent) Technology and related product candidates.
Forward
Looking Statements
This
press release contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995 (the "Act"). Acura
Pharmaceuticals, Inc. and King Pharmaceuticals, Inc. disclaim any intent or
obligation to update these forward-looking statements, and claim the protection
of the Safe Harbor for forward-looking statements contained in the
Act. Such forward-looking statements involve known and unknown risks,
uncertainties and other factors which may cause actual results, performance or
achievements to be materially different from any future results, performance, or
achievements expressed or implied by such forward-looking statements. These risk
factors include, but are not limited to, the plans and ability to develop,
obtain regulatory approvals, manufacture and commercialize any or all
Aversion®
Technology opioid product candidates, the ability to avoid infringement of
patents, trademarks and other proprietary rights of third parties, and the
ability to demonstrate or gain FDA approval of product labeling for the abuse
deterrent features and benefits of the product candidates utilizing
Aversion®
Technology. You are encouraged to review these and other risks and
uncertainties detailed in each Company’s respective 2007 SEC Form 10-K and
September 30, 2008 SEC Form 10-Q. When used in this press release, the words
"estimate," "project," "anticipate," "expect," "intend," "believe," and similar
expressions are intended to identify forward-looking statements.
EXECUTIVE
OFFICES
KING
PHARMACEUTICALS, INC.
501
FIFTH STREET, BRISTOL, TENNESSEE 37620
ACURA
PHARMACEUTICALS, INC.
616
N. NORTH COURT, PALATINE, ILLINOIS 60067
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