Acura Pharmaceuticals Announces Settlement of Oxecta(R) Patent Litigation With Par Pharmaceutical and Impax Laboratories

Acura Pharmaceuticals Announces Settlement of Oxecta(R) Patent Litigation With 
Par Pharmaceutical and Impax Laboratories 
PALATINE, IL -- (Marketwired) -- 10/09/13 --  Acura Pharmaceuticals,
Inc. (NASDAQ: ACUR), a specialty pharmaceutical company developing
products intended to address medication abuse and misuse, announced
today that it has entered into distinct Settlement Agreements with
each of Par Pharmaceutical and Impax Laboratories, to settle Acura's
patent infringement action pending against them in the United States
District Court for the District of Delaware. In the suit, Acura
alleges that a generic Oxecta(R) product for which each of Par and
Impax is separately seeking approval to market in the United States
pursuant to an Abbreviated New Drug Application (ANDA) filing with
the U.S. Food and Drug Administration (FDA) infringes a U.S. patent
owned by Acura. Par is the first filer of an ANDA for a generic
Oxecta(R) product and is entitled to the 180-day first filer
exclusivity under applicable law and FDA regulations.  
Under the terms of the Settlement Agreement with Par, Par may launch
its generic Oxecta(R) product in the U.S., through the grant of a
non-exclusive, royalty-bearing license from Acura to Par that would
trigger on January 1, 2022. Acura currently has Orange Book patents
that are due to expire between November 2023 and March 2025. In
certain limited circumstances, Acura's license to Par would become
effective prior to January 1, 2022. Par is required to pay Acura
royalties in the range of 10% to 15% of Par's net profits from the
sale of its generic Oxecta(R) product.  
Under the Settlement Agreement, Impax may launch its generic
Oxecta(R) product in the U.S., through the grant of a non-exclusive,
royalty-free license from Acura to Impax that would trigger 180 days
following the first sale of a generic Oxecta(R) product in the U.S.
by an entity that is entitled to the 180 day first-filer exclusivity
under applicable law and FDA regulations (or if no entity is entitled
to such 180 day exclusivity period, the date on which a generic
Oxecta(R) product is first sold in the U.S. or November 27, 2021,
whichever date occurs first). In certain circumstances, Acura's
license to Impax would become effective prior to such time.  
Acura's President and CEO, Bob Jones said, "We are very pleased with
these results, which reflect our continued confidence in the strength
of our patents while removing the uncertainty, distraction and cost
of litigation." 
The Settlement Agreements provide for a full settlement of all claims
that were asserted in each of the Par and Impax suits, subject to the
Court's acceptance of the stipulations of dismissal. As required by
law, the Settlement Agreements with Par and Impax will be submitted
to the U.S. Federal Trade Commission and US. Department of Justice. 
Background on the litigations settled 
On September 20, 2012, we announced that we had received a Paragraph
IV Certification notice from a generic sponsor of an ANDA for a
generic Oxecta(R) product. Since such date, we have received similar
Paragraph IV Certification notices from four other generic
pharmaceutical companies that have filed ANDAs for generic Oxecta(R)
products. As a result, on October 31, 2012, we initiated suit against
each of Watson Laboratories, Inc. - Florida (Watson), Par
Pharmaceutical, Inc. Impax Laboratories, Inc. and Sandoz Inc. in the
United States District Court for the District of Delaware. On April
29, 2013, we initiated suit against Ranbaxy Pharmaceuticals in the
United States District Court for the District of Delaware. In each
such litigation, we have alleged infringement of our U.S. Patent No.
7,510,726 listed in the FDA's Orange Book, and having an expiration
date in November 2023.  
On January 2, 2013, our motion to dismiss the litigation against
Watson on the grounds that Watson had amended its ANDA from a
Paragraph IV Certification to a Paragraph III Certification, which
indicated its intent not to market its generic Oxecta(R) product in
advance of our patent expiring, was accepted by the Court. The
Settlement Agreements with Par and Impax does not affect the status
of Acura's separate Oxecta(R) patent litigation against Sandoz and
Ranbaxy pending in the U.S. District Court for the District of
Delaware.  
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(R) Technologies. AVERSION contains polymers that cause the
drug to gel when dissolved; it also contains compounds that irritate
the nasal passages. IMPEDE is designed to disrupt the processing of
pseudoephedrine from tablets into methamphetamine. 
In June 2011, the U.S. Food and Drug Administration approved
OXECTA(R) (oxycodone HC1 tablets) which incorporates the AVERSION(R)
technology. The Company has a development pipeline of additional
AVERSION(R) technology products containing other opioids. 
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, that the U.S. District Court does
not approve the stipulation of dismissal of the litigation with each
of Par and Impax, that the U.S. Federal Trade Commission or the U.S.
Department of Justice challenge the enforceability of the Settlement
Agreements or that private plaintiffs challenged the Settlement
Agreements, whether or not additional third parties may seek to
market generic versions of Oxecta and the results of our pending
litigation or future litigation we may file to defend and/or assert
our patents against such companies, the possible occurrence of one of
these specific events that would result in Par or Impax marketing a
generic Oxecta product earlier than we anticipate, our and our
licensee's ability to successfully launch and commercialize our
products and technologies including Oxecta Tablets and Nexafed
Tablets, the price discounting that may be offered by
 Pfizer for
Oxecta, our and our licensee's ability to obtain necessary regulatory
approvals and commercialize products utilizing our technologies and
the market acceptance of and competitive environment for any of our
products, the willingness of wholesalers and pharmacies to stock
Nexafed Tablets, expectations regarding potential market share for
our products and the timing of first sales, our ability to enter into
additional license agreements for our Aversion Technology product
candidates, our exposure to product liability and other lawsuits in
connection with the commercialization of our products, the increasing
cost of insurance and the availability of product liability insurance
coverage, 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, our ability
to protect and enforce our patent rights in any paragraph IV patent
infringement litigation, 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 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," "indicates,"
"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. 
Contact:
for Acura Investor Relations
investors@acurapharm.com
847-705-7709 
for Acura Media Relations
pr@acurapharm.com
847-705-7709 
 
 
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