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): November
2, 2007 (October 30, 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
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|
(State
of Other Jurisdiction
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(Commission
File 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)
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| o |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
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| 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))
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Item
1.01 Entry
into a Material Definitive Agreement.
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”). The Agreement provides King with an exclusive license in the
Territory for Acurox™ (oxycodone HCl and niacin) Tablets (formerly known as
OxyADF) and another undisclosed opioid product utilizing Acura’s Aversion®
Technology (the “Licensed Products”). In addition, the Agreement provides King
with an option to license in the Territory all future opioid analgesic products
developed utilizing Acura’s Aversion® Technology (the “Future Products”). King’s
right to develop, manufacture and sell such Future Products is subject to King’s
exercise of its option rights for such Future Product, within 60 days after
King’s receipt of certain data from the Company demonstrating that such Future
Product has achieved Proof of Concept (as defined). The Licensed Products and
the Future Products are referred to herein collectively as the Products. The
Agreement will become effective upon the expiration or termination of the
applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements
Act
of 1976.
In
accordance with the Agreement, the Company and King will form a joint steering
committee to coordinate product development, regulatory and commercialization
strategies. The Company will retain responsibility, in consultation with King,
for all development and regulatory activities for Acurox™ Tablets through
regulatory approval by the FDA of the New Drug Application for such product
candidate. With
respect to all other products subject to the Agreement, King will be responsible
for development and regulatory activities following either acceptance of an
Investigational New Drug Application by the U.S. Food and Drug Administration
or
Acura's demonstration of certain stability and pharmacokinetic characteristics
for each product. Assuming King timely exercises its option relating to a Future
Product, King thereafter will be responsible for all development and regulatory
activities relating to such Future Product. King is responsible for all
manufacturing and commercialization activities in the Territory for the Licensed
Products and for the Future Products for which it has exercised its option.
King
will have final decision making authority with respect to all development and
commercialization activities for all Products subject to the
Agreement.
The
Company retains all rights to the Aversion® Technology outside of the Territory
and for the development, manufacture and sale in the Territory of products
not
licensed to King pursuant to the Agreement. Additionally, in the absence of
King’s timely exercise of its option for Future Product, all rights to such
Future Product shall be retained by the Company. King will own all clinical
data
and results, and regulatory submissions related to all Products developed under
the Agreement, provided that the Company will have access to such clinical
data
and regulatory submissions on a royalty-free basis for use in its retained
rights.
Under
the
terms of the Agreement, the Company will receive a non-refundable cash payment
of $30 million upon the satisfaction of closing conditions and the effectiveness
of the Agreement. The Company may receive additional non-refundable cash
milestone payments 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 hereto as Exhibit
10.1
and
incorporated herein by reference. A copy of the press release issued in
connection with the parties’ announcement of the Agreement is attached hereto as
Exhibit
99.1
and
incorporated by reference herein.
This
Report contains forward-looking statements about the Licensed Products, the
Future Products, and 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 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
9.01 Financial Statements and Exhibits
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Exhibit
Number
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|
Description
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10.1
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License,
Development and Commercialization Agreement dated October 30, 2007
between
the Company and King Pharmaceuticals Research and Development,
Inc.
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99.1
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Press
Release of the Registrant dated October 31,
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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By: |
/s/
Peter
Clemens |
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Peter
A. Clemens
Senior
Vice President & Chief Financial
Officer
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Date: November
2, 2007
EXHIBIT
INDEX
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Exhibit
Number
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Description
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| |
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10.1
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License,
Development and Commercialization Agreement dated October 30, 2007
between
the Company and King Pharmaceuticals Research and Development,
Inc.*
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99.1
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Press
Release of the Registrant dated October 31,
2007.
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*
Certain
information has been omitted and filed separately with the Securities and
Exchange Commission. Confidential treatment has been requested with respect
to
the omitted portion.