King Pharmaceuticals, Inc. and Acura Pharmaceuticals, Inc. announced that the companies have entered into a License, Development and Commercialisation Agreement for the United States, Canada, and Mexico encompassing a potentially wide range of opioid analgesic products utilizing Acura's patented Aversion (abuse-deterrent) Technology platform.
The companies have initially targeted development and commercialisation of four immediate release opioid analgesic products, including Acurox Tablets (oxycodone HCl, niacin, and a unique combination of other ingredients), formerly known as OxyADF, for treating moderate to severe acute pain.
"This transaction demonstrates our commitment to building on our strengths in specialty markets where we have a strong presence and existing capabilities. We are excited about partnering with Acura, which directly aligns with our recently announced emphasis on King's neuroscience and hospital/acute care platforms, particularly our growing pain management franchise," said, Brian A. Markison, chairman, president and CEO, King.
"We believe King's abuse-deterrent analgesic brand product pipeline and neuroscience expertise perfectly complement our Aversion Technology platform. King is clearly leading the pharmaceutical industry with its understanding of the opportunities and challenges relating to the market for products designed to discourage prescription drug abuse," said Andy Reddick, president and CEO, Acura.
Reddick added, "We look forward to working closely with King to bring innovative immediate release opioid analgesic products to market utilizing our Aversion (abuse-deterrent) Technology. Discouraging prescription drug abuse benefits patients, healthcare providers, third party payers, and society as a whole, while at the same time we expect to create substantial value for King and Acura shareholders."
The agreement provides King with an exclusive license in the Territory for Acurox Tablets and another undisclosed opioid product utilizing Acura's Aversion Technology. In addition, the Agreement provides King with an option to license in the Territory all future opioid analgesic products developed utilizing Acura's Aversion Technology.
Under the terms of the agreement, King will make an upfront cash payment to Acura of $30 million. Depending on the achievement of certain development and regulatory milestones, King could also make additional cash payments to Acura of up to $28 million relating to Acurox tablets and similar amounts with respect to each subsequent Aversion Technology product developed under the agreement. King will reimburse Acura for all research and development expenses incurred beginning from September 19, 2007 for Acurox Tablets and all research and development expenses related to future products after King's exercise of its option to an exclusive license for each future product. King will record net sales of all products and pay Acura a royalty ranging from 5 per cent to 25 per cent based on the level of combined annual net sales for all products subject to the Agreement. King will also make a one-time cash payment to Acura of $50 million in the first year in which the combined annual net sales of all products exceed $750 million.
King and Acura will form a joint steering committee to coordinate development and commercialisation strategies. With King's oversight, Acura will conduct all Acurox Tablet development activities through approval of a New Drug Application ("NDA") and thereafter King will commercialise Acurox in the US With respect to all other products subject to the Agreement, King will be responsible for development and regulatory activities following either acceptance of an Investigational New Drug Application by the US Food and Drug Administration ("FDA") or Acura's demonstration of certain stability and pharmacokinetic characteristics for each future product. All products developed pursuant to the Agreement will be manufactured by King or a third party contract manufacturer under the direction of King. Subject to the Agreement, King will have final decision making authority with respect to all development and commercialisation activities for all products licensed.
Acurox (formerly OxyADF) is an orally administered immediate release tablet containing oxycodone HCl as an active analgesic ingredient, niacin as an active ingredient in subtherapeutic amounts, and a unique combination of other ingredients. Acurox Tablets are intended to effectively treat moderate to moderately severe pain while discouraging the three most common methods of prescription drug abuse including (i) intravenous injection of dissolved tablets, (ii) nasal snorting of crushed tablets and (iii) intentional swallowing of excessive numbers of tablets.
Earlier this year, Acura reached agreement with the FDA on a Special Protocol Assessment for a pivotal phase III clinical trial evaluating Acurox Tablets. This clinical trial is a randomised, double-blind, placebo-controlled, multi-centre, repeat-dose study evaluating the safety and efficacy of Acurox Tablets for the treatment of acute, moderate to moderately severe postoperative pain. The 3-arm clinical trial compares two dose levels of Acurox Tablets to placebo and is targeted to enrol 135 patients per arm (approximately 405 patients in total). Study medication will be administered to patients every six hours for 48 hours following the onset of moderate to severe pain following bunionectomy surgery. This pivotal Phase 3 clinical trial began enrolling patients in September with a final study report expected in the second half of 2008.