Acura Pharmaceuticals, Inc. Announces the Retirement of William A. Sumner From Board of Directors

Acura Pharmaceuticals, Inc. announced today William A. Sumner has retired as a member of our Board of Directors and affiliated subsidiary after 14 years of service. Mr. Sumner has agreed to serve as Director Emeritus following his resignation. In such capacity, Mr. Sumner may attend Board and Committee meetings and participate in the discussion of matters at such meetings, but he will not have voting rights on any such matters.Mr. Sumner has been a member of our Board of Directors since August, 1997 and joined after a long and distinguished career in the pharmaceutical industry. From 1974 until his retirement in 1995, Mr. Sumner held various positions within Hoechst-Roussel Pharmaceuticals, Inc., including Vice President and General Manager, Dermatology Division from 1991 through 1995, Vice President, Strategic Business Development, from 1989 to 1991 and Vice President, Marketing from 1985 to 1989. Since his retirement from Hoechst-Roussel Pharmaceuticals, Inc. in 1995, Mr. Sumner has served as a consultant in the pharmaceutical industry.As a member of Acura's Board, Mr. Sumner helped to oversee the transformation of Acura from a troubled generic pharmaceutical manufacturer to a branded specialty pharmaceutical company engaged in research of proprietary technologies to address the abuse and misuse of pharmaceutical products.Remarking on the Mr. Sumner's retirement, Richard Markham, Chairman of the Board stated, "We are very grateful to Bill for his many years of outstanding service to the Company. Bill's willingness to serve as Director Emeritus will allow the Board to continue to avail itself of his wisdom, judgment and experience."The vacancy on our Board created by Mr. Sumner's retirement will remain until the Board appoints a successor.

Acura Pharmaceuticals, Inc. Announces Notice of Allowance for Third Aversion(R) Technology Patent

Acura Pharmaceuticals, Inc. (Nasdaq:ACUR) announced today receipt from the United States Patent and Trademark Office ("USPTO") of a Notice of Allowance for a non-provisional patent application related to our abuse deterrent Aversion(R) Technology platform. A U.S. patent relating to this Notice of Allowance will be granted after the Company pays the required fees. Upon issuance, this patent will be the third U.S. patent covering our Aversion(R) Technology and our opioid analgesic product candidates and broadens our patent coverage to include other abused drug classes such as stimulants and benzodiazepines.

About Acura Pharmaceuticals, Inc.

Acura Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in research, development and manufacture of product candidates intended to introduce limits or impediments to abuse and misuse utilizing our proprietary Aversion(R) and Impede(R) Technologies, and other novel technologies.

Acura Pharmaceuticals files briefing package for pain drug

Acura Pharmaceuticals, a specialty pharmaceutical company, has submitted a briefing package to the FDA addressing the issues raised in the FDA's June 30, 2009 complete response letter related to the new drug application for Acurox tablets.

Acura and King Pharmaceuticals R&D, are scheduled to meet with the FDA in late third quarter 2009 to discuss the complete response letter and the briefing package.

According to Acura, Acurox is an immediate release tablet with a proposed indication for the relief of moderate-to-severe pain. Acurox incorporates Acura's Aversion technology and is intended to discourage product misuse and abuse.

Acura and King, its exclusive licensee in the US, Canada and Mexico, are developing Acurox and three additional opioid analgesic products utilizing Aversion technology.

FDA denies approval of King, Acura's pain drug

* FDA issues complete response letter to the two cos

* Raises questions on the drug's abuse-deterrent properties

* Cos believe can address issues without additional trials

* Acura shares fall as much as 15 pct, King down 3 pct (Adds analyst comments; updates stock movement)

BANGALORE India, - Acura Pharmaceuticals Inc (ACUR.O) and King Pharmaceuticals Inc (KG.N) said U.S. health regulators denied approval of their pain drug, Acurox, and raised questions on the potential abuse-deterrent benefits of the drug.

The companies, which were issued a complete response letter by the U.S. Food and Drug Administration, said they expect to respond to the issues raised in the letter without conducting any additional studies.

"This is all that Acurox is, its abuse-deterrent. And now there are questions about what FDA thinks about those benefits. It sounds pretty bad," Biologic Investment Research analyst Kevin McNamara said.

McNamara, who has a "sell" rating on the stock, said it is highly unlikely that the drug might even get approved as a branded generic form of oxycodone.

Late last month, Acura had received a preliminary review letter from FDA, and said that based on that letter it was no longer expecting an approval by the June 30 action date. Acurox, which includes the powerful pain reliever oxycodone, contains components designed to thwart prescription drug abuse, which can be common with opioid pain drugs.

The FDA had said in February that it wanted manufacturers to take stronger measures to prevent misuse and abuse of long-acting and sustained-release opioids, a class of powerful, highly addictive narcotics prescribed to relieve chronic pain.

Apart from Acurox, Acura has two more pain drugs, Acuracet and Vycavert, in the pipeline, and they are also designed to resist common methods of abuse through intravenous injection of dissolved drugs, nasal snorting of crushed tablets or swallowing in excess quantities.

"The other pipeline drugs are essentially the exact same thing (abuse-deterrent painkillers). So today's news can apply to their entire portfolio," Biologic Investment's McNamara said.

Shares of Acura fell to a low of $5.01 but pared losses to trade up 6 cents at $5.97 Thursday morning on Nasdaq. King shares were down 3 percent at $9.53 on the New York Stock Exchange.

Small Cap Network Issues Analysis of Pharmaceutical Stocks AMAG, ACUR, ACAD

The Small Cap Network, a leading online investment community focused on small cap stocks, has issued an analysis of pharmaceutical stocks AMAG Pharmaceuticals, Inc. (AMAG), Acura Pharmaceuticals Inc. (ACUR), and ACADIA Pharmaceuticals, Inc. (ACAD).

The article explores not just the fundamental aspects of these drug-maker stocks, but also the technical aspects of their charts. For instance, one is an attractive company, but may be overbought for the time being. Another stock is priced under $2.00, and may be attractive based solely on a very inexpensive entry level.

PennyStockChaser.com: King Pharmaceuticals, Inc. (NYSE: KG) Hot Stock on the Move!

NEW ORLEANS -- King Pharmaceuticals, Inc. and Acura Pharmaceuticals, Inc. (NASDAQ: ACUR) today presented the results from an oral abuse liability study of Acurox(R) (oxycodone HCl/niacin) Tablets, AP-ADF-111 (Study 111), at the American Society of Addiction Medicine's (ASAM) Medical-Scientific Conference. The results of Study 111 demonstrate that Acurox(R) Tablets are disliked among people with a history of opioid abuse compared to oxycodone HC1 tablets alone, when excess doses are swallowed. Dr. Donald R. Jasinski, Chief of the Center for Chemical Dependence of Johns Hopkins Bayview Medical Center, authored the study.

"The fact that people with a history of opioid abuse showed a disliking of the Acurox(R) Tablets in excessive doses is an indication that the product is an important step in the development of medicines that are designed to deter common methods of abuse, such as over ingestion, while effectively managing pain," said Dr. Jasinksi. "The ASAM Meeting provides a premier forum for King and Acura to share insights with addiction specialists and hear feedback that can lead to further advances in pain medication treatments."

King and Acura are jointly developing Acurox(R) Tablets whose New Drug Application has been granted a priority review classification by The U.S. Food and Drug Administration (FDA). The companies expect a response from the FDA by June 30, 2009.

Study 111 - A Phase II, Single-Center, Randomized, Double-Blind Assessment of the Abuse Liability of Oxycodone HC1/Niacin Tablets (Acurox(R) Tablets) in Subjects with a History of Opioid Abuse

Acurox(R) Tablets contain a unique composition of oxycodone HCl, niacin, and essential functional inactive ingredients, and are intended to relieve moderate-to-severe pain while deterring common methods of prescription drug abuse including intentionally swallowing excess quantities of tablets, crushing and snorting tablets, and dissolving tablets for injection. Niacin is well tolerated at the recommended two-tablet dose, however, as doses are escalated, niacin induces increasingly unpleasant, dysphoric, yet temporary, effects.

To assess the effect of oxycodone HCl on the niacin-induced effects of Acurox(R), 30 subjects with a history of opioid abuse were administered 240 mg of niacin alone, Acurox(R) at four times the recommended 5mg/30mg tablet dose (40mg/240mg), and placebo, in randomized, crossover fashion (Sequence 1). To assess the abuse liability of Acurox(R) versus oxycodone HCl alone, the subjects were administered Acurox(R) at four times the recommended dose and oxycodone HCl 40mg alone in randomized, crossover fashion (Sequence 2).

The primary efficacy measure of abuse deterrence potential in Study 111 was determined using a 29-point visual analogue scale (Drug Rating Questionnaire-Subject) which assessed the subjects' like/dislike of a drug's effects. In Sequence 1, results demonstrated with statistical significance (p=0.03) that niacin 240mg was disliked compared to placebo, and oxycodone HCl 40mg had limited effect on niacin-induced disliking. In Sequence 2, it was demonstrated with clinically meaningful and statistically significant results (p=.033) that administration of excessive numbers of Acurox(R) Tablets equivalent to 40mg of oxycodone HCl (i.e., four times the intended 2 tablet dose) was aversive at 30 minutes compared to oxycodone HCl 40mg alone.

About Prescription Drug Abuse

The undertreatment of pain is a major public health issue complicated by abuse of prescription opioids. More than 75 million Americans suffer from pain, which is more than the number of people with diabetes, heart disease and cancer combined. While there are a number of effective prescription pain medications available, the increasing misuse, abuse and diversion of prescription pain medications - especially among young adults - is having a major impact on physicians' ability and/or willingness to treat pain and is impeding patient access to medicines and care. According to the National Institute on Drug Abuse, nearly 10 percent of high school seniors have abused Vicodin(R), a commonly used short acting opioid pain medicine. The increasing misuse, abuse and diversion of opioid pain medications have become widespread and pose a costly and significant public health issue in and of itself. In 2005, the estimated total cost associated with opioid abuse, including health care, justice, and work-related costs, totaled $9.5 billion. The pain relief medicines that Acura is developing with King are designed to address this problem.

Acura Pharmaceuticals Inc. Reports Operating Results

Acura Pharmaceuticals Inc. (ACUR) filed Quarterly Report for the period ended 2009-03-31.

Halsey Drug Company Inc. is engaged in the manufacture sale and distribution of generic drugs. A generic drug is the chemical and therapeutic equivalent of a brand-name drug for which patent protection has expired. The company sells its generic drug products under its Halsey label and under private-label arrangements with drugstore chains and drug wholesalers. Acura Pharmaceuticals Inc. has a market cap of $296.6 million; its shares were traded at around $6.94 with a P/E ratio of 14.5 and P/S ratio of 6.8.

Highlight of Business Operations:

As of March 31, 2009, we had received aggregate payments of $55.4 million from King, consisting of a $30.0 million non-refundable upfront cash payment, $14.4 million in reimbursed research and development expenses relating to Acurox® Tablets, $6.0 million in fees relating to King s exercise of its option to license an undisclosed opioid analgesic tablet product and Vycavert™ Tablets, and a $5.0 million milestone fee for successful achievement of the primary endpoints for our pivotal Phase III clinical study for Acurox® Tablets. The King Agreement provides for King to pay us: (a) a $3.0 million option exercise fee for each future opioid product candidate King licenses, (b) up to $23 million in regulatory milestone payments for each King licensed product candidate, including Acurox® Tablets, across specific countries in the King Territory, and (c) a one-time $50 million sales milestone payment upon the first attainment of an aggregate of $750 million in net sales of all of our licensed products combined in all King Territories. In addition, for sales occurring following the one year anniversary of the first commercial sale of the first licensed product sold, King will pay us a royalty at one of 6 rates ranging from 5% to 25% based on the level of combined annual net sales for all products licensed by us to King in all King Territories, with the highest applicable royalty rate applied to such combined annual sales. No minimum annual fees are payable by either party under the King Agreement.

In December, 2007, we and King Research and Development Inc., ("King") closed a License, Development and Commercialization Agreement (the “King Agreement”) to develop and commercialize certain opioid analgesic products utilizing our proprietary Aversion® Technology in the United States, Canada and Mexico. During the three months ended March 31, 2009, we recognized revenues of $1.3 million of the $30.0 million upfront cash payment received from King in December 2007 and recognized $0.1 million of revenues for reimbursement by King of our Acurox® Tablet development expenses. We have yet to generate any royalty revenues from product sales. We expect to rely on our current cash resources and additional payments that may be made under the King Agreement and under similar license agreements with other pharmaceutical company partners, of which there can be no assurance, in funding our continued operations. Our cash requirements for operating activities may increase in the future as we continue to conduct pre-clinical studies and clinical trials for our product candidates, maintain, defend, if necessary and expand the scope of our intellectual property, hire additional personnel, or invest in other areas.

King paid us a $30.0 million upfront fee in connection with the closing of the King Agreement in December 2007. Revenue recognized in the three month periods ended March 31, 2009 and 2008 from amortization of this upfront fee was $1.3 million and $13.7 million, respectively. We have assigned a portion of the program fee revenue to each of three product candidates identified under the King Agreement and expect to recognize the remainder of the program fee revenue ratably over our estimate of the development period for each of these product candidates identified in the King Agreement. We currently estimate the development period to extend through November, 2009.

Collaboration revenue recognized in the three month periods ended March 31, 2009 and 2008 was $0.1 million and $3.4 million for billed reimbursement of our Acurox® Tablet development expenses incurred pursuant to the King Agreement. We invoice King in arrears on a calendar quarter basis for our reimbursable development expenses under the King Agreement. We expect the amount and timing of collaboration revenue to fluctuate in relation to the amount and timing of the underlying research and development expenses.

Marketing expenses during the three month periods ended March 31, 2009 and 2008 consisted of Aversion® Technology primary market data research studies. Our general and administrative expenses primarily consisted of legal, audit and other professional fees, corporate insurance, and payroll. Included in the 2009 and 2008 results are non-cash stock-based compensation charges of $1.3 million and $0.1 million, respectively. Excluding the stock-based compensation expense, there is a $0.4 million increase in general, administrative and marketing expenses primarily in areas such as $0.1 million for patent legal services, $0.1 million for state franchise taxes and $0.2 million for incentive compensation accruals.

At March 31, 2009, the Company had unrestricted cash and cash equivalents of $37.0 million compared to $35.4 million in cash, cash equivalents and short-term investments at December 31, 2008. The Company had working capital of $36.3 million at March 31, 2009 compared to $36.0 million at December 31, 2008. The increase in our cash position of $1.6 million is primarily due to the collection of our collaboration revenue receivable during the three month period ending March 31, 2009. Cash flows generated in operating activities were $1.6 million for the three month period ended March 31, 2009 primarily representing the collection of the collaboration revenue receivable offset by the period s net loss adjusted for certain non cash items such as deferred program fee revenue, deferred income taxes, and charges for stock compensation. Cash flow used in operating activities for the three month period ended March 31, 2008 primarily represented our recognition of deferred program fee revenue offset by the period s net income and change in deferred income taxes. The cash flow from investing activities resulted from the maturity of our short term investments during the 2009 period and the purchase of short term investments for the 2008 period.