Acura Pharmaceuticals Announces Update on AVERSION Products
Company's Q2'12 Financial Results Release Rescheduled for Monday, July 30
PALATINE, IL--(Marketwire - Jul 27, 2012) - Acura Pharmaceuticals, Inc. (NASDAQ: ACUR), a specialty pharmaceutical company developing products intended to address medication abuse and misuse, announced today that Pfizer Inc. provided notice on July 26, 2012 that it is exercising its right to terminate the license to three development stage products using Acura's AVERSION® Technology and return such products to Acura. The termination will become effective in 12 months under the terms of our License Agreement with a subsidiary of Pfizer. A fourth product utilizing Acura's AVERSION Technology, OXECTA® (oxycodone hydrochloride) Tablets CII, is being commercialized by Pfizer and Pfizer will retain all rights and obligations to OXECTA under the License Agreement.
The products being returned are oxycodone hydrochloride with acetaminophen, hydrocodone bitartrate with acetaminophen and another undisclosed opioid. The hydrocodone product is the most advanced in development, with a clinical study completed in February 2012, which demonstrated bioequivalence to its reference listed drug. This product also was the subject of a pre-IND meeting held with the U.S. Food and Drug Administration (FDA) in May 2012 in which the FDA agreed to a development program for this product generally consistent with that used for OXECTA.
"We are pleased to regain control of these tamper-resistant opioid products because we continue to believe they hold promise in combating widespread prescription opioid abuse," said Bob Jones, President and Chief Executive Officer of Acura Pharmaceuticals. "We will evaluate our strategy for these products over the coming months, including possible partnering with alternative strategic partners, and will work with Pfizer to exercise our rights under the Pfizer Agreement for the transition of these products back to us."
Acura now plans to report financial results for the second quarter of 2012 following the close of financial markets on Monday, July 30, 2012. The Company will host a conference call on Tuesday, July 31, 2012 at 8:30 a.m. ET to discuss the quarterly results and Pfizer's return of the development products.
To participate in the live conference call, please dial 800-967-0627 (U.S. and Canada) or 913-981-5535 (international) five to ten minutes prior to the start of the call. The participant passcode is 8419237. A live audio webcast will also be available through the "Investors" section of the company's website, http://www.acurapharm.com
The conference call and the webcast will be archived for two weeks. The telephone replay of the call will be available approximately two hours after completion of the call by dialing 888-203-1112 (U.S. and Canada) or 719-457-0820 (international), and providing passcode 8419237.
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® and IMPEDE™
technologies. In June 2011, the U.S. Food and Drug Administration
approved OXECTA® 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® 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® Tablets and Nexafed® Tablets, the price
discounting that may be offered by Pfizer for Oxecta®, 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.
Contact Information
Contact:
David Carey for Acura Investor Relations
investors@acurapharm.com
212-867-1768
Chris Seger for Acura Media Relations
pr@acurapharm.com
212-599-1265
Posted: July 2012
