Unassociated Document
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
June
3,
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
On
June
3, 2008 Acura
Pharmaceuticals, Inc. issued the attached press release being furnished as
Exhibit 99.1, announcing receipt from the United States Patent and Trademark
Office of a Notice of Allowance for a certain non-provisional patent
application.
Item
9.01 Financial
Statements and Exhibits
Exhibit
Number
|
Description
|
|
|
99.1
|
Press
Release of the Registrant dated June 3,
2008.
|
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: June
4,
2008
EXHIBIT
INDEX
Exhibit
Number
|
Description
|
|
|
99.1
|
Press
Release of the Registrant dated June 3,
2008.
|
Unassociated Document
|
|
|
Acura
Pharmaceuticals Contact:
Peter
A. Clemens, SVP Investor Relations & CFO
847-705-7709
|
|
|
|
|
FOR
IMMEDIATE RELEASE
ACURA
PHARMACEUTICALS, INC. ANNOUNCES NOTICE OF ALLOWANCE
FOR
SECOND AVERSION® TECHNOLOGY PATENT
Palatine,
IL, June 3, 2008:
Acura
Pharmaceuticals, Inc. (NasdaqCM:
ACUR)
today
announced receipt from the United States Patent and Trademark Office of a Notice
of Allowance for a non-provisional patent application titled “Methods and
Compositions for Deterring Abuse of Opioid Containing Dosage Forms”. A U.S.
patent relating to this Notice of Allowance will be granted after the Company
pays the required patent issue fees. Today's announcement provides the Company
with 21 new allowed patent claims intended to enhance and broaden the patent
coverage provided by the 54 issued claims in the Company's first patent relating
to deterring abuse of opioids granted in April 2007 (U.S. Patent No.
7,201,920).
In
addition to the Notice of Allowance and the April 2007 issued patent (both
described above), the Company has four published U.S. non-provisional patent
applications and multiple pending international patent applications relating
to
the Company's proprietary Aversion® (abuse deterrent) Technology.
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 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.