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): December
7, 2007
___________________________________________________________
ACURA
PHARMACEUTICALS, INC.
(Exact
Name of Registrant as Specified in Charter)
___________________________________________________________
|
State
of New York
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1-10113
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11-0853640
|
|
(State
of Other Jurisdiction
|
(CommissionFile
Number)
|
(I.R.S.
Employer
|
|
of
Incorporation)
|
|
Identification
Number)
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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
1.01 Entry
into a Material Definitive Agreement.
As
previously reported, on October 30, 2007, Acura Pharmaceuticals, Inc. (the
“Company”) and King Pharmaceuticals Research and Development, Inc. (“King”), a
wholly-owned subsidiary of King Pharmaceuticals, Inc., entered into a License,
Development and Commercialization Agreement (the “Agreement”) to develop and
commercialize certain opioid analgesic products utilizing the Company's
proprietary Aversion® (abuse deterrent) Technology in the United States, Canada,
and Mexico (the “Territory”). On December 7, 2007, the Agreement closed and
became effective as a result of the termination of the applicable waiting period
under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. On the same
date
the Company received from King a non-refundable cash payment of $30 million.
The
Company may receive additional non-refundable cash milestone payments from
King
based on the successful achievement of certain clinical and regulatory
milestones for Acurox™ Tablets and for each other product developed under the
Agreement. The Company may also receive an additional $50 million non-refundable
cash milestone payment when the aggregate net sales of all products developed
under the Agreement reach $750 million. In addition, the Company will receive
from King royalty payments ranging from 5% to 25% based
on
the combined annual net sales of all products developed under the Agreement.
King’s royalty payment obligations commence on the first anniversary of the
first commercial sale of a product and expire on the later of the expiration
of
the last to expire valid patent claim covering such product or 15 years from
the
first commercial sale of such product in such country.
On
a
quarterly basis during the term of the Agreement, King will reimburse Acura
for
its expenses incurred to develop the licensed products, consisting of all of
the
Company’s out-of-pocket expenses and internal research and development staff
costs allocated to the development of such products. The Company’s development
expenses to be funded by King include those relating to (i) Acurox™ Tablets
commencing September 19, 2007, (ii) qualifying a third-party supplier of the
products, (iii) successfully achieving Proof of Concept for any future product
for which King does not exercise its option to license such future product
in
the Territory, and (iv) product line extensions (as defined) for a product
as
agreed to by the parties.
The
foregoing provides only a brief summary of selected provisions of the Agreement
and is qualified in its entirety by reference to the text of the Agreement
attached to the Form 8-K filed by the Company on November 2, 2007 as
Exhibit
10.1
and is
incorporated herein by reference. A copy of the press release issued in
connection with [Acura’s][the
parties’]
announcement of the closing of the Agreement is attached hereto as Exhibit
99.1
and
incorporated by reference herein.
This
Report contains forward-looking statements about the Agreement between the
Company and King. As with any pharmaceutical product under development or
proposed to be developed, substantial risks and uncertainties exist in the
process of development, regulatory review and commercialization. There can
be no
assurance that any product developed utilizing Aversion® Technology will receive
regulatory approval or prove to be commercially successful. Accordingly,
investors in the Company should recognize that there is no assurance that the
Company will receive any additional milestone payment amounts described above
for Acurox™ Tablets (formerly OxyADF) or any other product candidate utilizing
Aversion® Technology, or even if such milestones are achieved, that the related
products will be successfully commercialized. For further discussion of these
and other risks and uncertainties, see the Company’s Annual Report on Form 10-K
for the year ended December 31, 2006, under the heading “Risks Factors”, its
most recent quarterly report on Form 10-Q and its other public disclosures
filed
with the U.S. Securities and Exchange Commission.
Item
2.04 Triggering Events That Accelerate or Increase a Direct Financial Obligation
or an Obligation under an Off-Balance Sheet Arrangement.
On
December 7, 2007, pursuant to the terms of the Agreement with King, the Company
received from King an upfront non-refundable cash payment of $30 million upon
the satisfaction of the closing conditions and the effectiveness of the
Agreement. In accordance with the terms of the Agreement and the Company’s Loan
Agreement dated March 29, 2000, as amended, between the Company and its lenders
(the “Loan Agreement”), simultaneous with the Company’s receipt from King of the
$30 million upfront cash payment, the Company prepaid in full the $4.992 million
principal balance plus unpaid interest under the Loan Agreement.
Item
9.01 Financial
Statements and Exhibits
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Exhibit
Number
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Description
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| |
|
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99.1
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Press
Release of the Registrant dated December 10,
2007.
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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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ACURA
PHARMACEUTICALS, INC. |
|
|
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| Date: December
10, 2007 |
By: |
/s/ Peter
Clemens |
| |
Peter
A. Clemens |
| |
Senior
Vice President & Chief Financial
Officer |
EXHIBIT
INDEX
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Exhibit
Number
|
Description
|
| |
|
|
99.1
|
Press
Release of the Registrant dated December 10,
2007.
|