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
March
26, 2009
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)
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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
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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))
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|
o
|
Pre-commencement communications
pursuant to Rule 13e-4(c) under the Exchange Act (17CFR
240.13e-4(c))
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Item
8.01 Other Events.
On March 26, 2009 we issued a press
release announcing that Garth Boehm, Ph.D. has been named Vice President,
Modified Release Dosage Form Development and is expected to commence employment
with us in May 2009. A copy of the press release is furnished as
Exhibit 99.1.
Item
9.01 Financial Statements and
Exhibits.
|
Exhibit
Number
|
Description |
|
99.1
|
Press
Release dated March 26, 2009 Announcing the Appointment of Dr. Garth Boehm
as Vice President of Modified Release Dosage Form
Development.
|
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 | |||
| Senior Vice President & Chief FinancialOfficer | |||
Date:
March 26, 2009
|
Exhibit
Number
|
Description |
|
99.1
|
Press
Release dated March 26, 2009 Announcing the Appointment of Dr. Garth Boehm
as Vice President of Modified Release Dosage Form
Development.
|
 |
|
 |
Acura
Pharmaceuticals Contact:
Peter
A. Clemens, SVP Investor Relations & CFO
847-705-7709
|
FOR
IMMEDIATE RELEASE
ACURA PHARMACEUTICALS, INC.
NAMES
GARTH BOEHM, Ph.D. VP OF
MODIFIED RELEASE
DOSAGE FORM
DEVELOPMENT
Palatine, IL, March 26, 2009:
Acura Pharmaceuticals, Inc. (NASDAQ: ACUR) is pleased to announce that Garth
Boehm, Ph.D. has been named Vice President, Modified Release Dosage Form
Development. Dr. Boehm, is currently employed as Vice President of
Product Development at Actavis Pharmaceuticals and is expected to commence
employment with Acura in May 2009.
Andy
Reddick, Acura’s President and CEO said: “We are delighted that Dr.
Boehm will be joining our talented research, development, and senior management
teams. With more than 25 years of pharmaceutical experience, Garth is
one of the industry’s most accomplished extended release (ER) dosage form
development scientists. He has authored or co-authored multiple
issued and pending patent applications relating to ER dosage forms and abuse
deterrent product formulations. He was the primary driver in the
formulation development and manufacturing scale-up of the leading marketed US
brand of morphine sulfate ER capsules and co-inventor of the technology utilized
in morphine sulfate and naltrexone HCl ER capsules, a product intended to be
abuse deterrent, currently pending FDA approval. Dr. Boehm has been
an advisor to the FDA regarding complex product content uniformity issues and
over the years been responsible in leadership roles for a wide array of
scientific disciplines including product formulation and development, quality
assurance and quality control. Garth and his scientific teams have
been responsible for dozens of US regulatory submissions and subsequent FDA
approvals for brand and generic products. In his role at Acura as
Vice President of Modified Dosage Form Development, Dr. Boehm will report
directly to me and work closely with Al Brzeczko, Ph.D., Acura’s Vice President
of Technical Affairs. We look forward to working with Dr. Boehm as we
remain intensely focused on developing a broad array of proprietary products
with unique abuse deterrent features and benefits.”
About
Acura Pharmaceuticals, Inc.
Acura
Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in research,
development and manufacture of innovative Aversion® (abuse
deterrent) Technology and related product candidates.
About
Forward Looking Statements
Certain
statements in this press release constitute "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of 1995. When
used in this press release, the words "estimate," "project," "anticipate,"
"expect," "intend," "believe," and similar expressions are intended to identify
forward-looking statements. Such forward-looking statements involve
known and unknown risks, uncertainties and other factors which may cause our
actual results, performance or achievements to be materially different from any
future results, performance, or achievements expressed or implied by such
forward-looking statements. The most significant of such factors include, but
are not limited to, our ability, or the ability of other pharmaceutical
companies, to whom we may license our technology and/or product candidates, to
obtain necessary regulatory approvals and commercialize products utilizing our
proprietary technologies, the ability to avoid infringement of patents,
trademarks and other proprietary rights of third parties, and the ability to
fulfill the U.S. Food and Drug Administration’s (“FDA”) requirements for
approving our product candidates for commercial manufacturing and distribution
in the United States, including, without limitation, the adequacy of the results
of the laboratory and clinical studies completed to date and the results of
other laboratory and clinical studies, to support FDA approval of our product
candidates, the adequacy of the development program for our product candidates,
changes in regulatory requirements, adverse safety findings relating to our
product candidates, the unpredictability of the duration and results of FDA
review of filings made with the FDA relating to our product candidates, the risk
that the FDA may not agree with our analysis of our clinical studies and may
evaluate the results of these studies by different methods or conclude that the
results of the studies are not statistically significant, clinically meaningful
or that there were human errors in the conduct of the studies, the risk that
further studies of our product candidates are not positive or otherwise do not
support FDA approval or commercially viable product labeling, and the
uncertainties inherent in scientific research, drug development, clinical trials
and the regulatory approval process. Other important factors that may
also affect future results include, but are not limited to: our ability to
attract and retain highly skilled personnel; our ability to timely submit
regulatory filings with the FDA; our ability to secure and protect our patents,
trademarks and proprietary rights; litigation or regulatory action that could
require us to pay significant damages or change the way we conduct our business;
our ability to compete successfully against current and future competitors; our
dependence on third-party suppliers of raw materials; our ability to secure U.S.
Drug Enforcement Administration ("DEA") quotas and source the active ingredients
of our products in development; difficulties or delays in clinical trials for
our product candidate or in the commercial manufacture and supply of our
products; and other risks and uncertainties detailed in our 2008 Form 10-K filed
with the Securities and Exchange Commission (SEC) You are
encouraged to review other important risk factors on our web site at
www.acurapharm.com under the link, “Company Risk Factors” and detailed in our
filings with the SEC. We assume no obligation to update any
forward-looking statements as a result of new information or future events or
developments. Our press releases may be reviewed at
www.acurapharm.com.
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