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
October
17, 2005
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 (17CFR
240.14a-12)
o› Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act
(17CFR240.14d-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
October 17, 2005, Acura Pharmaceuticals, Inc. (the "Company") issued a press
release announcing the Company’s receipt from the U.S. Food and Drug
Administration (“FDA”) of communications clarifying previous FDA correspondence
relating to the development of Product Candidate #2 announced on October
3,
2005. The FDA’s most recent communication provides assurance that the Company
may promptly resume planned clinical studies of Product Candidate #2 without
conducting additional pre-clinical testing. A copy of the Company’s Press
Release is attached hereto as Exhibit 99.1.
Item
9.01 Financial
Statements and Exhibits.
|
Exhibit
Number
|
Description |
|
99.1
|
Press
Release dated October 17, 2005 Announcing Receipt of clarifying
FDA
Communication.
|
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 A. Clemens | |
|
Peter A. Clemens |
||
| Vice President & Chief Financial Officer | ||
| Date: October 17, 2005 | ||
EXHIBIT
INDEX
|
Exhibit
Number
|
Description |
|
99.1
|
Press
Release dated October 17, 2005 Announcing Receipt of clarifying
FDA
Communication.
|
CONTACT:
Acura
Pharmaceuticals, Inc.
Investor
Relations, Peter A. Clemens, SVP & CFO 847-705-7709
FOR
IMMEDIATE RELEASE
ACURA
PHARMACEUTICALS, INC. RECEIVES CLARIFICATION FROM FDA
ABOUT
CLINICAL PROGRAM; CASH RESERVES UPDATE
Palatine,
IL, October 17, 2005:
Acura
Pharmaceuticals, Inc. (OTC.BB-ACUR) today announced receipt from the United
States Food and Drug Administration (“FDA”) communications clarifying previous
FDA correspondence relating to the development of Product Candidate #2 announced
by the Company on October 3, 2005. The FDA’s most recent communication provides
assurance that the Company may promptly resume planned clinical studies of
Product Candidate #2 without conducting additional pre-clinical
testing.
Cash
Reserves Update
The
Company estimates that current cash reserves will fund operating expenses only
through November 11,
2005
assuming a waiver from existing bridge loan lenders (the “Lenders”) allowing use
of $200,000 pledged as security against such bridge loans. The Company can
provide no assurance that the Lenders will grant such waiver.
If such
waiver is not granted prior to October 25, 2005 the Company may be required
to
seek protection under applicable bankruptcy laws.
Assuming
that the Company receives the aforementioned waiver, to continue operating
after
November 11, 2005, the Company must obtain additional financing or enter into
appropriate collaboration agreement(s) with third parties providing for cash
payments to the Company. The Company can provide no assurance that it will
be
successful in obtaining any such financing or entering into appropriate
collaborative agreements, on acceptable terms, if at all, or if obtained, that
such financing or collaborative agreements will provide sufficient cash to
continue funding operations. In the absence of such financing or third-party
collaborative agreements, the Company will be required to scale back or
terminate operations and/or seek protection under applicable bankruptcy
laws.
Acura
Pharmaceuticals, Inc., together with its subsidiaries, is an emerging
pharmaceutical technology development company specializing in proprietary opioid
abuse deterrent, abuse resistant, and tamper resistant formulation
technology.
This
press release contains forward looking statements, within the meaning of Section
27A of the Securities Act of 1933 and Section 21E of the Securities Act of
1934,
as amended that are based on management's beliefs and assumptions, current
expectations, estimates and projections. Investors are cautioned that forward
looking statements involve risks, uncertainties and other factors, which could
cause actual results to differ materially from future results expressed or
implied by such forward looking statements. The most significant of such factors
include, but are not limited to, general economic conditions, competitive
conditions, technological conditions and governmental legislation. More
specifically, important factors that may affect future results include, but
are
not limited to: changes in laws and regulations, particularly those affecting
the Company’s operations; the Company's
ability to continue to attract, assimilate and retain highly skilled
personnel;
its
ability
to secure and protect its patents, trademarks and proprietary rights; litigation
or regulatory action that could require the Company to pay significant damages
or change the way it conducts its business; the Company’s ability to
successfully develop and market its products; customer responsiveness to new
products and distribution channels; its
ability to compete successfully against current and future
competitors;
its
dependence on third-party suppliers of raw materials; the availability of
controlled substances that constitute the active ingredients of the Company’s
products in development; difficulties or delays in clinical trials for Company
products or in the manufacture of Company products; and other risks and
uncertainties detailed in Company filings with the Securities and Exchange
Commission. The Company is at an early stage of development and may not ever
have any products that generate significant revenue.
Further,
the forward looking statements speak only as of the date of such statements
are
made, and the Company undertakes no obligation to update any forward looking
statements to reflect events or circumstances after the date of such statements.
Any or all of the forward looking statements whether included in this release
or
in the Company’s filings with the Securities and Exchange Commission, may turn
out to be wrong. Readers should remember that no forward looking statement
can
be guaranteed and other factors besides those listed above could adversely
affect the Company, its operating results or financial condition.
This
and
past press releases for Acura Pharmaceuticals, Inc. are available at Acura’s web
site at www.acurapharm.com.