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
May
27,
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
May
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, to license
from us a third 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
|
| Exhibit Number |
Description
|
| 99.1 |
Press
Release of the Registrant dated May 27,
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: May 27, 2008
EXHIBIT
INDEX
| ExhibitNumber |
Description
|
| 99.1 |
Press
Release of the Registrant dated May 27,
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 THIRD OPIOID
PRODUCT
UTILIZING
ACURA’S AVERSION® TECHNOLOGY
Represents
Third of Four Immediate-Release Opioid Products
Initially Targeted
BRISTOL,
TENNESSEE and PALATINE, ILLINOIS, May 27, 2008 - King Pharmaceuticals,
Inc.
(NYSE: KG) and Acura Pharmaceuticals, Inc. (NASDAQ: ACUR) today announced
that
King has exercised its option to license a third immediate-release opioid
analgesic product utilizing Acura’s proprietary AVERSION® Technology.
King
and
Acura entered into a License, Development and Commercialization Agreement
in
October 2007 (the “Agreement”). The Agreement provides King with an exclusive
license to ACUROX™ (oxycodone HCl, niacin, and functional inactive ingredients)
tablets and another undisclosed opioid product, and an option to license
all
future opioid analgesic products formulated with Acura’s AVERSION® Technology.
In connection with the exercise of its option for this third opioid product
under the Agreement, King paid Acura an option exercise fee of $3.0
million.
As
a
result, the companies are now jointly developing three immediate-release
opioid
analgesics utilizing Acura’s AVERSION®
Technology, which are designed to resist or deter common methods of prescription
drug misuse and abuse.
Brian
A.
Markison, Chairman, President and Chief Executive Officer of King, stated,
“King
Pharmaceuticals is dedicated to developing a range of pain treatment solutions
formulated to deliver optimal pain relief while reducing the risk of misuse,
abuse and diversion. Accordingly, we are pleased to add another
immediate-release opioid product that utilizes the AVERSION®
Technology platform to our development pipeline.”
Robert
B.
Jones, Chief Operating Officer of Acura, commented, “Achieving the proof of
concept milestone associated with this product and King's exercise of their
option further demonstrates the applicability of the AVERSION® Technology
platform to a wide range of products susceptible to abuse.”
About
AVERSION®
Technology
AVERSION®
Technology is a patented platform. King and Acura are developing
immediate-release pain medicines using this technology. These investigational
medicines incorporate proven opioid pain relievers with a sub therapeutic
amount
of niacin and
a
unique
composition of functional inactive ingredients. Opioid
pain medicines developed utilizing AVERSION®
Technology are intended to relieve moderate to severe pain and resist or
deter
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
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 in attractive markets and the strategic
acquisition of branded products that can benefit from focused promotion
and
marketing and life-cycle management.
1
About
Acura Pharmaceuticals
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
release contains forward-looking statements which reflect managements’ current
views of future events and operations, including, but not limited to, plans
to
develop immediate-release opioid analgesic products utilizing Acura’s
proprietary AVERSION® Technology platform. These forward-looking statements
involve certain significant risks and uncertainties, and actual results
may
differ materially from the forward-looking statements. Some important factors
which may cause actual results to differ materially from the forward-looking
statements include dependence on the
companies’ ability to continue to advance the development of its pipeline
products as planned; dependence on the high cost and uncertainty of research,
clinical trials, and other development activities involving pharmaceutical
products in which the companies’ have an interest; dependence on the
unpredictability of the duration and results of the U.S. Food and Drug
Administration review of Investigational New Drug applications, New Drug
Applications and/or the review of other regulatory agencies worldwide that
relate to products in development; dependence on the availability and cost
of
raw materials; dependence on no material interruptions in supply by contract
manufacturers of products in development; dependence on the affect of the
potential development and approval of other new competitive products; dependence
on unexpected adverse side-effects or inadequate therapeutic efficacy of
the
companies’ drug candidates that could slow or prevent product approval or market
acceptance (including the risk that current and past results of clinical
trials
are not necessarily indicative of future results of clinical trials).
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 King’s and Acura’s respective Form 10-K for the year ended
December 31, 2007 and Form 10-Q for the quarter ended March 31, 2008 which
are
on file with the U.S. Securities and Exchange Commission. The companies
do not
undertake to publicly update or revise any of their forward-looking statements
even if experience or future changes show that the indicated results or
events
will not be realized.
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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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