Transaction Expands King's Near-term Pipeline of Products Designed to Deter
Common Methods of Opioid Abuse
BRISTOL, Tenn. and PALATINE, Ill., Oct. 31 /PRNewswire-FirstCall/ --
King Pharmaceuticals, Inc. (NYSE: KG) and Acura Pharmaceuticals, Inc. (OTC
Bulletin Board: ACUR) announced today that the companies have entered into
a License, Development and Commercialization Agreement (the "Agreement")
for the United States, Canada, and Mexico (the "Territory") encompassing a
potentially wide range of opioid analgesic products utilizing Acura's
patented Aversion(R) (abuse-deterrent) Technology platform. The companies
have initially targeted development and commercialization of four immediate
release opioid analgesic products, including ACUROX(TM) Tablets (oxycodone
HCl, niacin, and a unique combination of other ingredients), formerly known
as OxyADF, for treating moderate to severe acute pain.
Brian A. Markison, Chairman, President and CEO of King, stated, "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."
Andy Reddick, President and CEO of Acura said, "We believe King's
abuse- deterrent analgesic brand product pipeline and neuroscience
expertise perfectly complement our Aversion(R) 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."
Mr. Reddick added, "We look forward to working closely with King to
bring innovative immediate release opioid analgesic products to market
utilizing our Aversion(R) (abuse-deterrent) Technology. Discouraging
prescription drug abuse benefits patients, healthcare providers, third
party payors, and society as a whole, while at the same time we expect to
create substantial value for King and Acura shareholders."
Dr. Eric Carter, Chief Science Officer of King, commented, "Opioid
analgesics play a very important role in the effective management of
moderate to severe pain. However, abuse and misuse of these medicines
represents a major area of concern among physicians, pharmacists, patients,
and the health- care sector. At King, we are committed to addressing this
important public health issue and the needs of our customers by offering
pain medicines that are proven effective and incorporate safe and
appropriate means to discourage abuse and misuse."
Dr. Carter added, "We believe Acura and our long-established partner,
Pain Therapeutics, have developed unique platforms designed to address the
challenges related to abuse and misuse of immediate release and long-acting
pain medicines. Acura's innovative and proprietary Aversion(R) Technology
has the potential to significantly reduce common methods of abuse
associated with immediate release opioids used for the treatment of acute
pain. Similarly, REMOXY(TM) (long acting oral oxycodone) and other
long-acting opioids that we are jointly developing with Pain Therapeutics
utilizing Durect Corporation's SABER(TM) formulation technology have
significant potential to deter common methods of abuse associated with
long-acting opioids used for the treatment of chronic pain."
"Our alliance with Acura will help further address this growing
opportunity and adds considerable strength to King's pipeline, allowing for
the development of multiple future medicines," concluded Dr. Carter.
About the License, Development and Commercialization Agreement
The Agreement provides King with an exclusive license in the Territory
for ACUROX(TM) Tablets (formerly OxyADF) and another undisclosed opioid
product utilizing Acura's Aversion(R) 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(R)
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(TM) Tablets and
similar amounts with respect to each subsequent Aversion(R) Technology
product developed under the Agreement. King will reimburse Acura for all
research and development expenses incurred beginning from September 19,
2007 for ACUROX(TM) 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% to 25% 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 commercialization strategies. With King's oversight, Acura
will conduct all ACUROX(TM) Tablet development activities through approval
of a New Drug Application ("NDA") and thereafter King will commercialize
ACUROX(TM) in the U.S. 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 U.S. 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 commercialization
activities for all products licensed.
The Agreement closing is subject to antitrust review under the
Hart-Scott- Rodino Antitrust Improvements Act.
The United States Patent and Trademark Office has granted U.S. Patent
No. 7,201,920 relating to Acura's Aversion(R) (abuse-deterrent) Technology,
which expires on March 16, 2025.
About ACUROX(TM) Tablets
ACUROX(TM) (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(TM) 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 3 clinical trial evaluating
ACUROX(TM) Tablets. This clinical trial is a randomized, double-blind,
placebo- controlled, multi-center, repeat-dose study evaluating the safety
and efficacy of ACUROX(TM) Tablets for the treatment of acute, moderate to
moderately severe postoperative pain. The 3-arm clinical trial compares two
dose levels of ACUROX(TM) Tablets to placebo and is targeted to enroll 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.
About King Pharmaceuticals
King, headquartered in Bristol, Tennessee, is a vertically integrated
branded pharmaceutical company. King, an S&P 500 Index company, seeks to
capitalize on opportunities in the pharmaceutical industry through the
development, including through in-licensing arrangements and acquisitions,
of novel branded prescription pharmaceutical products in attractive markets
and the strategic acquisition of branded products that can benefit from
focused promotion and marketing and life-cycle management.
About Acura Pharmaceuticals
Acura Pharmaceuticals, Inc. is a specialty pharmaceutical company
engaged in research, development and manufacture of innovative Aversion(R)
(abuse deterrent) Technology and related product candidates.
Forward-looking Statements
This release contains forward-looking statements which reflect
managements' current views of future events and operations, including, but
not limited to, statements pertaining to the expected benefits to the
companies' shareholders as a result of the Agreement; statements pertaining
to the potential of the Aversion(R) Technology and SABER(TM) formulation
technology to reduce some common methods of abuse of opioids; statements
pertaining to the expected timetable for the ACUROX(TM) Tablets Phase 3
clinical trial; and statements pertaining to the potential for the
companies to successfully develop multiple future products. These
forward-looking statements involve certain significant risks and
uncertainties, and actual results may differ materially from the
forward-looking statements. Some important factors which may cause actual
results to differ materially from the forward-looking statements include
dependence on the successful development and commercialization of
ACUROX(TM) Tablets and other products subject to the Agreement; dependence
on the companies' abilities to obtain the necessary regulatory approvals
and close the transaction as expected; dependence on the companies'
abilities to successfully manufacture products subject to the Agreement
following the necessary regulatory approval; dependence on the companies'
compliance with FDA and other government regulations that relate to their
respective businesses; dependence on the successful development and
commercialization of REMOXY(TM) and other products that King is jointly
developing with Pain Therapeutics; dependence on unexpected changes in
technologies and technological advances; dependence on changes in general
economic and business conditions, current pricing levels, federal and state
laws and regulations, and competition; and dependence on manufacturing
capacity constraints. Other important factors that may cause actual results
to differ materially from the forward-looking statements are discussed in
the "Risk Factors" section and other sections of each of King's and Acura's
respective Form 10-K for the year ended December 31, 2006 and their
respective Form 10-Q for the quarter ended June 30, 2007, which are on file
with the U.S. Securities and Exchange Commission. The companies do not
undertake to publicly update or revise any of their forward-looking
statements even if experience or future changes show that the indicated
results or events will not be realized.
SOURCE King Pharmaceuticals, Inc.; Acura Pharmaceuticals, Inc.
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Related links:
http://www.kingpharm.com
http://www.prnewswire.com/comp/120319.html/
CONTACT:
James E. Green, Executive Vice President,
Corporate Affairs, +1-423-989-8125; or David E. Robinson, Senior
Director, Corporate Affairs, +1-423-989-7045, both of King
Pharmaceuticals; Peter A. Clemens, SVP Investor Relations & CFO,
+1-847-705-7709, of Acura Pharmaceuticals
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