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
July
18,
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)
|
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 (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 (17CFR
240.13e-4(c))
|
Item
8.01 Other
Events
In
June
2008, we received a Notice of Allowance for a non-provisional patent
application 11/716,122 titled “Methods and Compositions for Deterring Abuse of
Opioid Containing Dosage Forms” (the “122 Application”). After further review of
one of the 21 claims contained in the Notice of Allowance, and after
consideration of a potential interference proceeding relating to a third party
patent application containing a similar claim, on July 18, 2008, we filed with
the United States Patent and Trademark Office, a Request for Continued
Examination relating to the 122 Application and simultaneously cancelled one
of
the 21 claims included in the Notice of Allowance.
A
copy of
the press release issued by us with respect to the aforementioned matter is
being furnished as Exhibit 99.1.
Item
9.01 Financial
Statements and Exhibits
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
Clemens
Peter
A.
Clemens
Senior
Vice President & Chief Financial Officer
Date: July
21,
2008
EXHIBIT
INDEX
 |
Acura
Pharmaceuticals Contact:
Peter
A. Clemens, SVP Investor Relations & CFO
847-705-7709
|
FOR
IMMEDIATE RELEASE
ACURA
PHARMACEUTICALS, INC. ANNOUNCES ACTION REGARDING
NOTICE
OF ALLOWANCE RECEIVED FOR SECOND AVERSION® TECHNOLOGY PATENT
Palatine,
IL, July 21, 2008:
Acura
Pharmaceuticals, Inc. (NasdaqCM: ACUR) today announced that it has filed
with
the United States Patent and Trademark Office (“USPTO”) a Request for Continued
Examination relating to the Notice of Allowance received in June, 2008 for
its
non-provisional patent application 11/716,122 titled “Methods and Compositions
for Deterring Abuse of Opioid Containing Dosage Forms” (the “122 Application”).
After further review of one of the 21 claims discussed in the Notice of
Allowance and after consideration of a potential interference proceeding
relating to a third party patent application containing a similar claim,
the
Company filed with the USPTO a Request for Continued Examination relating
to the
122 Application and simultaneously cancelled one of the 21 allowed claims.
Although no assurance can be given, based on the USPTO’s prior review of the 122
Application, we expect that a Notice of Allowance for the remaining 20 claims
included in 122 Application will be granted by the USPTO in the coming months.
The 20 claims included in our amended 122 Application are intended to enhance
and broaden the patent coverage provided by the 54 issued claims in the
Company's first patent relating to our Aversion® Technology for deterring abuse
of opioids.
About
Aversion® (abuse deterrent) Technology
Aversion®
Technology is a patented platform for developing pharmaceutical products
containing potentially abuseable drugs including oxycodone, hydrocodone,
oxymorphone, hydromorphone, morphine, codeine, tramadol, propoxyphene, and
many
other opioid analgesics. We believe this platform technology is also applicable
to non-opioid products that are subject to abuse and which fall into two
broad
categories, Central Nervous System depressants (including tranquilizers and
sedatives) and stimulants. Aversion® Technology is applicable to orally
administered tablets and capsules. In addition to the active ingredient,
Aversion® Technology utilizes certain proprietary compositions of inactive
ingredients and active ingredients intended to discourage the most common
methods of pharmaceutical product misuse and abuse including; (i) intravenous
injection of dissolved tablets or capsules, (ii) nasal snorting of crushed
tablets or capsules and (iii) intentional swallowing of excess quantities
of
tablets or capsules.
About
Acura Pharmaceuticals, Inc.
Acura
Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in research,
development and pilot manufacture of innovative Aversion® (abuse deterrent)
Technology and related product candidates.
Forward-looking
Statements
Certain
statements in this press release constitute "forward-looking statements"
within
the meaning of the Private Securities Litigation Reform Act of 1995. Such
forward-looking statements involve known and unknown risks, uncertainties
and
other factors which may cause our actual results, performance or achievements
to
be materially different from any future results, performance, or achievements
expressed
or
implied by such forward-looking statements. The most significant of such
factors
include, but are not limited to, our ability, the ability of King
Pharmaceuticals (to whom we have licensed our Aversion Technology for certain
opioid analgesic products in the United States, Canada and Mexico) and the
ability of other pharmaceutical companies, if any, to whom we may license
our
Aversion® Technology, to obtain necessary regulatory approvals and commercialize
products utilizing the Aversion® Technology, the ability to avoid infringement
of patents, trademarks and other proprietary rights of third parties, and
the
ability to fulfill the U.S. Food and Drug Administration’s (“FDA”) requirements
for approving our product candidates for commercial manufacturing and
distribution in the United States, including, without limitation, the adequacy
of the results of the laboratory and clinical studies completed to date and
the
results of other laboratory and clinical studies, to support FDA approval
of our
product candidates, the adequacy of the development program for our product
candidates, changes in regulatory requirements, adverse safety findings relating
to our product candidates, the risk that the FDA may not agree with our analysis
of our clinical studies and may evaluate the results of these studies by
different methods or conclude that the results of the studies are not
statistically significant, clinically meaningful or that there were human
errors
in the conduct of the studies or otherwise, the risk that further studies
of our
product candidates are not positive or otherwise do not support FDA approval
or
commercially viable product labeling, and the uncertainties inherent in
scientific research, drug development, clinical trials and the regulatory
approval process. Other important factors that may also affect future results
include, but are not limited to: our ability to attract and retain highly
skilled personnel; our ability to secure and protect our patents, trademarks
and
proprietary rights; litigation or regulatory action that could require us
to pay
significant damages or change the way we conduct our business; our ability
to
compete successfully against current and future competitors; our dependence
on
third-party suppliers of raw materials; our ability to secure U.S. Drug
Enforcement Administration ("DEA") quotas and source the active ingredients
of
our products in development; difficulties or delays in clinical trials for
our
product candidate or in the commercial manufacture and supply of our products;
and other risks and uncertainties detailed in this Report. When used in this
press release, the words "estimate," "project," "anticipate," "expect,"
"intend," "believe," and similar expressions are intended to identify
forward-looking statements. You are encouraged to review other important
risk
factors relating to our operations on our web site at www.acurapharm.com
under
the link, “Company Risk Factors” and detailed in our filings with the Securities
and Exchange Commission. We assume no obligation to update any forward-looking
statements as a result of new information or future events or developments.
Our
press releases may be reviewed at www.acurapharm.com.