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
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
of
Incorporation)
|
(Commission
File Number)
|
(I.R.S.
Employer
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
December 11, 2006, the Registrant issued the Press Release attached hereto
as
Exhibit 99.1.
Item
9.01 Financial
Statements and Exhibits
Exhibit
Number |
Description |
99.1 |
Press
Release dated December 11, 2006 Announcing
Notice
of Allowance For Issuance of Patent for
Deterring
Abuse of Opioid Containing Dosage Forms
|
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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|
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ACURA
PHARMACEUTICALS, INC. |
|
|
|
|
By: |
/s/ Peter
Clemens |
|
Peter
A. Clemens |
|
Senior
Vice President & Chief Financial Officer |
Date: December
11, 2006 |
|
Exhibit
Index
Exhibit
Number |
Description |
99.1 |
Press
Release dated December 11, 2006 Announcing
Notice
of Allowance For Issuance of Patent for
Deterring
Abuse of Opioid Containing Dosage
Forms
|
Unassociated Document
CONTACT:
Acura
Pharmaceuticals, Inc.,
Investor
Relations, Peter A. Clemens, SVP & CFO 847-705-7709
FOR
IMMEDIATE RELEASE
ACURA
PHARMACEUTICALS, INC. ANNOUNCES NOTICE OF ALLOWANCE FOR ISSUANCE OF PATENT
FOR
DETERRING ABUSE OF OPIOID CONTAINING DOSAGE FORMS
Palatine,
IL, December 11, 2006:
Acura
Pharmaceuticals, Inc. (OTC.BB-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
fees. The patent claims in the Notice of Allowance are directed to
pharmaceutical compositions intended to reduce or discourage the three most
common routes of prescription opioid analgesic product misuse and abuse (the
Company's "Aversion®
Technology")
including; (i) intravenous injection of dissolved tablets or capsules; (ii)
snorting of crushed tablets or capsules and; (iii) intentionally swallowing
excess quantities of tablets or capsules. The opioid analgesics in the allowed
patent claims include oxycodone, hydrocodone, hydromorphone, morphine, codeine,
tramadol, propoxyphene and many others. At present, the Company retains
ownership of all intellectual property and commercial rights to its Aversion®
Technology.
Potential
Market for Opioid Analgesic Products with Aversion®
Technology
According
to IMS Health, for the 12 month period ending September 30, 2006, there were
more than 225 million dispensed prescriptions in the U.S. for opioid analgesics.
The Company believes that healthcare providers generally are unable to predict
which, if any, of their opioid analgesic prescriptions will ultimately be abused
or diverted to non-medical use. Based on primary market research conducted
by
the Company, physicians in the U.S. believe that nearly one out of six
prescriptions for oxycodone and hydrocodone containing products may be abused.
In addition, the results of a survey published in 2006 of over 1,500 adults
conducted by Schulman, Ronca and Bucuvalas, Inc., a market research firm,
revealed that 37% of those surveyed personally know someone who has abused
opioid painkillers. Of those reporting knowing someone who has abused opioid
painkillers, ten percent revealed that they personally had abused these products
and nearly twenty percent of the abusers were identified as coworkers, with
the
balance being identified as family members or acquaintances. The uncertainty
about which, if any, prescriptions for opioid analgesics will be abused or
diverted to non-medical use implies that certain segments of the U.S. market
for
opioid analgesic prescriptions may represent an attractive opportunity for
products formulated with the Company's Aversion® Technology.
OxyADF
Tablet Development
OxyADF
Tablets, the Company’s lead product candidate utilizing Aversion® Technology, is
an orally administered immediate release tablet containing oxycodone HCl as
its
sole active analgesic ingredient with an anticipated indication for treating
acute moderate to moderately severe pain. OxyADF Tablets are being developed
pursuant to an active investigational new drug application on file with the
United States Food and Drug Administration (“FDA”).
To
date the Company, in concert with contract research organizations, has completed
patient enrollment in two phase I clinical trials (AP-ADF-101and AP-ADF-107),
two phase II clinical trials (AP-ADF-102 and AP-ADF 103), a pivotal
bioequivalence trial (AP-ADF-104) and a pivotal laboratory study assessing
the
relative difficulty of extracting oxycodone HCl from OxyADF Tablets for the
purposes of illicit intravenous injection.
The
FDA
has stated to the Company that successful completion of additional clinical
trials and related study reports is required prior to the FDA’s acceptance of a
505(b)(2) NDA submission for OxyADF Tablets. These required activities include;
(a) unblinding of data, analysis and report writing for study AP-ADF-102, a
phase II clinical trial in 24 subjects with a history of opioid abuse; (b)
data
analysis and a final report for study AP-ADF-107, a phase I clinical trial
assessing dose response to a certain ingredient in the OxyADF Tablet composition
in 50 healthy normal subjects; (c) successful completion of study AP-ADF-105,
a
placebo controlled, pivotal phase III clinical trial in approximately 400 acute
pain patients and; (d) an additional three or four phase I clinical studies
with
approximately 25-50 normal subjects per study.
Estimating
the dates of initiation and completion of clinical studies and the costs to
complete development of the Company's product candidates, including OxyADF
Tablets, would be speculative and potentially misleading. The Company expects
to
reassess its future research and development plans pending review of data
received from development activities in progress and the availability of cash
resources to fund these activities. The cost and pace of future research and
development activities are linked and subject to change. At this stage there
can
be no assurance that any of the Company’s research and development efforts,
including those for OxyADF Tablets, will lead to a 505(b)(2) NDA submission
or
that if NDA submissions are made, that any such submission will be accepted
for
filing or approved by the FDA.
About
Acura Pharmaceuticals, Inc.
Acura
Pharmaceuticals, Inc., together with its subsidiary, is a specialty
pharmaceutical company primarily engaged in research, development and
manufacture of products incorporating Aversion® Technology.
Forward
Looking Statements
This
press release contains "forward-looking statements" as defined in the Private
Securities Litigation Reform Act of 1995. These statements are based on current
expectations of future events. If underlying assumptions prove inaccurate or
unknown risks or uncertainties materialize, actual results could vary materially
from the Company’s expectations and projections. The most significant of such
risks and uncertainties include, but are not limited to, the Company’s ability
to secure additional financing to fund continued product development and
operations, the Company’s ability to enter into contractual arrangements with
qualified pharmaceutical partners to license, develop and commercialize the
Company’s technology and product candidates, the Company’s ability to avoid
infringement of patents, trademarks and other proprietary rights or trade
secrets of third parties, and the Company’s ability to fulfill the FDA’s
requirements for approving the Company’s product candidates for commercial
distribution in the United States, including, without limitation, the adequacy
of the results of the clinical studies completed to date and the results of
other clinical studies, to support FDA approval of the Company’s product
candidates, the adequacy of the development program for the Company’s product
candidates, changes in regulatory requirements, adverse safety findings relating
to the Company’s product candidates, the risk that the FDA may not agree with
the Company’s analysis of its 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 the Company’s product candidates are not positive, and the
uncertainties inherent in scientific research, drug development, clinical trials
and the regulatory approval process. You are encouraged to review other
important risk factors relating to the Company on our web site at
www.acurapharm.com under the link, “Company Risk Factors” and detailed in
Company filings with the Securities and Exchange Commission. The Company is
at
development stage and may never have any products or technologies that generate
revenue. Acura Pharmaceuticals, Inc. assumes no obligation to update any
forward-looking statements as a result of new information or future events
or
developments. All Acura Pharmaceuticals, Inc. press releases may be reviewed
at
www.acurapharm.com.