Acura Pharmaceuticals Announces Earlier Return of Development Products

Wed Sep 26, 2012 4:15pm EDT

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  PALATINE, IL, Sep 26 (Marketwire) -- 
Acura Pharmaceuticals, Inc. (NASDAQ: ACUR), a specialty pharmaceutical
company developing products intended to address medication abuse and
misuse, announced today a letter agreement with Pfizer Inc. providing for
the termination of Pfizer's license to Acura's AVERSION Technology used
in three developmental opioid products as of September 26, 2012 and the
transfer of those products back to Acura. On July 26, 2012 Acura was
notified by Pfizer of its intention to terminate the license to the three
development products which carried a 12 month notice period under the
terms of the companies' 2007 license agreement.

    The developmental products being returned to Acura are oxycodone
hydrochloride with acetaminophen, hydrocodone bitartrate with
acetaminophen and a third previously unnamed opioid, all of which utilize
Acura's AVERSION technology. The AVERSION Technology utilizes a
proprietary mixture of inactive ingredients to discourage tampering of a
product for abusive purposes. "We are pleased that Pfizer agreed to an
earlier return of these products for development by Acura," said Bob
Jones, President and Chief Executive Officer of Acura Pharmaceuticals.

    About Acura Pharmaceuticals
 Acura Pharmaceuticals is a specialty
pharmaceutical company engaged in the research, development and
commercialization of product candidates intended to address medication
abuse and misuse, utilizing its proprietary AVERSION(R) and IMPEDE(TM)
technologies. In June 2011, the U.S. Food and Drug Administration
approved OXECTA(R) which incorporates the AVERSION technology. The
Company has a development pipeline of additional AVERSION technology
products including other opioids and its IMPEDE technology for
pseudoephedrine hydrochloride products.

    The trademark OXECTA(R) is owned by Pfizer Inc.

    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. 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.
Forward-looking statements may include, but are not limited to, our and
our licensee's ability to successfully launch and commercialize our
products and technologies including Oxecta(R) Tablets and Nexafed(R)
Tablets, the price discounting that may be offered by Pfizer for
Oxecta(R), the ability of us or our licensee's to obtain necessary
regulatory approvals and commercialize products utilizing our
technologies and the market acceptance of and competitive environment for
any of our products, expectations regarding potential market share for
our products and the timing of first sales, our ability to enter into
additional license agreements for our other product candidates, the
ability to avoid infringement of patents, trademarks and other
proprietary rights of third parties, and the ability of our patents to
protect our products from generic competition, and the ability to fulfill
the 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, the results of laboratory and clinical studies
we may complete in the future to support FDA approval of our product
candidates and the sufficiency of our development to meet
over-the-counter, or OTC, Monograph standards as applicable, the adequacy
of the development program for our product candidates, including whether
additional clinical studies will be required to support FDA approval of
our product candidates, changes in regulatory requirements, adverse
safety findings relating to our product candidates, whether the FDA will
agree with our analysis of our clinical and laboratory studies and how it
may evaluate the results of these studies or whether further studies of
our product candidates will be required to support FDA approval, whether
or when we are able to obtain FDA approval of labeling for our product
candidates for the proposed indications and will be able to promote the
features of our abuse discouraging technologies, whether our product
candidates will ultimately deter abuse in commercial settings and whether
our Impede technology will disrupt the processing of pseudoephedrine into
methamphetamine. In some cases, you can identify forward-looking
statements by terms such as "may," "will," "should," "could," "would,"
"expects," "plans," "anticipates," "believes," "estimates," "projects,"
"predicts," "potential" and similar expressions intended to identify
forward-looking statements. These statements reflect our current views
with respect to future events and are based on assumptions and subject to
risks and uncertainties. Given these uncertainties, you should not place
undue reliance on these forward-looking statements. We discuss many of
these risks in greater detail in our filings with the Securities and
Exchange Commission.


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