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
September
3, 2009
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) | |
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 Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17CFR
240.14a-12)
o Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act
(17CFR240.14d-2(b))
o Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17CFR
240.13e-4(c))
Item
8.01 Other Events.
On September 3, 2009,
we announced that on September 2, 2009, King Pharmaceuticals, Inc.
and we (the “Companies”) met with the U.S. Food and Drug Administration
(“FDA”) regarding the FDA’s June 30, 2009 Complete Response Letter to our
New Drug Application (“NDA”) for Acurox®
(oxycodone hydrochloride and niacin) Tablets. At such meeting the FDA
and the Companies agreed to take the NDA to an FDA Advisory Committee to
consider the evidence to support the potential opioid abuse deterrent effects of
Acurox Tablets. The FDA indicated that no new clinical trials for
Acurox® Tablets
are required at this time. The FDA has not yet set a meeting date for the
Advisory Committee’s review of the NDA, however the Companies do not expect the
meeting to be convened before the end of this year.
The press
release announcing the foregoing is attached hereto as Exhibit
99.1.
We
entered into a License, Development and Commercialization Agreement with King
Pharmaceuticals Research and Development, Inc. (“King”), a wholly-owned
subsidiary of King Pharmaceuticals, Inc., in October 2007 pursuant to which we
and King are now jointly developing ACUROX® Tablets
and three additional opioid analgesic product candidates utilizing Aversion®
Technology.
FORWARD-LOOKING
STATEMENTS
This
report contains forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995 (the "Act"). When used in
this report, the words "estimate," "project," "anticipate," "expect," "intend,"
"believe," and similar expressions are intended to identify forward-looking
statements. Examples of forward-looking statements in this press
release include statements concerning our expectation of and timing for any such
Advisory Committee meeting. We 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, our ability to gain FDA approval of the Acurox®
Tablets NDA, and the timing of any such approval, whether additional clinical
studies will be required to support FDA approval of the Acurox® Tablets NDA, our
ability to gain FDA approval of product labeling for the proposed indication or
the abuse deterrent features and benefits of Acurox®, and the benefits of
Acurox® and the ability of Acurox® to deter abuse in actual
practice. 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 our Annual Report on Form 10-K for the
fiscal year ended December 31, 2008 and our Quarterly Reports on Form 10-Q for
each of the quarters ended March 31 and June 30, 2009, each of which is on file
with the U.S. Securities and Exchange Commission.
Item
9.01 Financial
Statements and Exhibits.
| Exhibit
Number
|
Description |
|
99.1
|
Press
Release dated September 3, 2009
|
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.
| ACURA PHARMACEUTICALS, INC. | |||
|
|
By:
|
/s/ Peter A. Clemens | |
|
Peter
A. Clemens
Senior
Vice President & Chief FinancialOfficer
|
|||
Date: September
3, 2009
| Exhibit
Number
|
Description |
|
99.1
|
Press
Release dated September 3,
2009
|
 |
King
Pharmaceuticals Contacts:
Investor
Relations: Jack Howarth
(908)
429-8350
|
|
Acura
Pharmaceuticals Contact:
Peter
A. Clemens, SVP Investor Relations & CFO
(847)
705-7709
|
|
| FOR IMMEDIATE RELEASE | |
ACURA
PHARMACEUTICALS AND KING PHARMACEUTICALS PROVIDE UPDATE ON ACUROX®
NDA
PALATINE, ILLINOIS and BRISTOL,
TENNESSEE, September 3, 2009 – Acura Pharmaceuticals, Inc. (NASDAQ: ACUR)
and King Pharmaceuticals, Inc. (NYSE: KG) announced today that they met with the
U.S. Food and Drug Administration ("FDA") on September 2, 2009 to discuss the
FDA’s June 30, 2009 Complete Response Letter regarding the New Drug Application
for Acurox® (oxycodone HCl and niacin) Tablets CII (NDA). The FDA and
the Companies agreed to take the NDA to an FDA Advisory Committee to consider
the evidence to support the potential opioid abuse deterrent effects of Acurox®
Tablets. The FDA indicated that no new clinical trials are required
at this time. The FDA has not yet set a meeting date for the Advisory
Committee’s review of the NDA. The Companies do not expect the
meeting to be convened before the end of this year.
About
ACUROX®
Tablets
ACUROX® is an
investigational, patented, orally administered, immediate release tablet
containing oxycodone HCl as its sole active analgesic ingredient with a proposed
indication for the relief of moderate-to-severe pain. ACUROX® utilizes
Acura’s proprietary Aversion®
Technology, which is designed to discourage some common methods of misuse and
abuse. The clinical significance of Aversion®
Technology has not been established.
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. Acura entered
into a License, Development and Commercialization Agreement with King
Pharmaceuticals Research and Development, Inc. (“King”), a wholly-owned
subsidiary of King Pharmaceuticals, Inc., in October 2007 pursuant to which
Acura and King are now jointly developing ACUROX® Tablets
and three additional opioid analgesic product candidates utilizing Aversion®
Technology.
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 and technologies that complement the
Company’s focus in specialty-driven markets, particularly neuroscience and
hospital. King’s wholly owned subsidiary, Alpharma Inc., is also a leader in the
development, registration, manufacture, and marketing of pharmaceutical products
for food-producing animals.
Forward
Looking Statements
This
press release contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995 (the "Act"). When used in this
press release, the words "estimate," "project," "anticipate," "expect,"
"intend," "believe," and similar expressions are intended to identify
forward-looking statements. Examples of forward-looking statements in this press
release include statements concerning the Companies’ expectation of and timing
for any such Advisory Committee meeting. 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, our ability to gain FDA approval of the Acurox® Tablets NDA, and
the timing of any such approval; whether additional clinical studies will be
required to support FDA approval of the Acurox® Tablets NDA; the Companies’
ability to gain FDA approval of product labeling for the proposed indication or
the abuse deterrent features and benefits of Acurox®; and the benefits of
Acurox® and the ability of Acurox® to deter abuse in actual
practice. 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 each of the Companies’ Annual Reports on
Form 10-K for the fiscal year ended December 31, 2008 and their respective
Quarterly Reports on Form 10-Q for each of the quarters ended March 31 and June
30, 2009, each of which is on file with the U.S. Securities and Exchange
Commission.
ADMINISTRATIVE
OFFICES
KING
PHARMACEUTICALS, INC.
501
FIFTH STREET, BRISTOL, TENNESSEE 37620
ACURA
PHARMACEUTICALS, INC.
616
N. NORTH COURT, PALATINE, ILLINOIS 60067