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
October
3, 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
|
(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 (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 3, 2005, Acura Pharmaceuticals, Inc. (the "Company") issued a press
release announcing the Company's receipt of communication from the U.S. Food
and
Drug Administration ("FDA") requesting certain non-clinical studies relating
to
the Company's Product Candidate #2. A copy of the Company's Press Release
is
attached hereto as Exhibit 99.1.
Item
9.01 Financial
Statements and Exhibits.
Exhibit
99.1
|
Press
Release dated October 3, 2005 Announcing Receipt of 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. |
|
|
|
Date: October
3, 2005 |
By: |
/s/ Peter
A. Clemens |
|
Peter
A. Clemens |
|
Vice
President & Chief Financial
Officer |
EXHIBIT
INDEX
Exhibit
99.1
|
Press
Release dated October 3, 2005 Announcing Receipt of FDA Communication.
|
Unassociated Document
FOR
IMMEDIATE RELEASE
ACURA
PHARMACEUTICALS, INC. RECEIVES COMMUNICATION FROM FDA
Palatine,
IL, October 3, 2005:
Acura
Pharmaceuticals, Inc. (OTC.BB-ACUR) today announced that the Company has
received correspondence from the United States Food and Drug Administration
(“FDA”) recommending certain non-clinical studies be conducted prior to
conducting further clinical testing of the Company’s Product Candidate #2. The
Company is therefore suspending the initiation of future clinical trials
for
Product Candidate #2 until the Company is able to more fully evaluate the
basis
for, and implications of, the FDA’s recommendations. The Company intends to
request a meeting with the FDA as quickly as possible to discuss all development
requirements for Product Candidate #2. At this time no meeting date with
FDA has
been established.
Cash
Reserves Update
The
Company estimates that its current cash reserves will fund continued development
of Product Candidate #2 and related operating expenses through
October,
2005.
To
continue operating, the Company must raise additional financing or enter
into
appropriate collaboration agreements with third parties providing for cash
payments to the Company. No assurance can be given that the Company will
be
successful in obtaining any such financing or in securing collaborative
agreements with third parties on acceptable terms, if at all, or if secured,
that such financing or collaborative agreements will provide for payments
to the
Company sufficient 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 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.