In December 2007, Acura and King Pharmaceuticals Research
and Development, Inc. (“King”), a wholly-owned subsidiary of King
Pharmaceuticals, Inc., closed a License, Development and
Commercialization Agreement (the “King Agreement” or "Agreement") to
develop and commercialize in the United States, Canada and Mexico (the
"King Territory") certain opioid analgesic products utilizing our
proprietary Aversion® Technology including Acurox™ Tablets. The
Agreement provides King with an exclusive license in the King Territory
for Acurox™ Tablets and another undisclosed opioid product candidate
utilizing Aversion® Technology. In addition, the King Agreement
provides King with an option to license in the King Territory all future
opioid analgesic products developed utilizing Acura's Aversion®
Technology. We encourage you to
review the Company’s filings with Securities and Exchange Commission for
more details about the King Agreement.
In December 2007, King made an upfront, non refundable
cash payment to us of $30.0 million pursuant to the Agreement.
Depending on the achievement of certain development and regulatory
milestones, King could also make additional cash payments to us of up to
$28 million relating to Acurox™ Tablets and similar amounts with respect
to each subsequent Aversion® Technology opioid product developed under
the Agreement. King will reimburse us 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 licensed products. For net sales occurring following the
one year anniversary of the first commercial sale of a licensed product,
King will pay us a royalty at one of six (6) rates ranging from 5% to
25% based on the level of combined annual net sales for all licensed
products subject to the Agreement. King will also make a one-time cash
payment to us of $50 million in the first year in which the combined
annual net sales of all products exceed $750 million.
In December 2007, we and King formed a Joint Steering
Committee to coordinate development and commercialization strategies for
all products licensed by King from Acura pursuant to the Agreement.
With King’s oversight, we will conduct all Acurox™ Tablet development
activities through approval of a 505(b)(2) New Drug Application (“NDA”)
and thereafter King will commercialize Acurox™ Tablets 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 ("IND") by the
U.S. Food and Drug Administration (“FDA”) or our demonstration of
certain stability and pharmacokinetic characteristics for each future
product. King will have final decision making authority with respect to
all development and commercialization activities for all licensed
Aversion® Technology opioid products.
In May, 2008, King and Acura announced that
King exercised its option to license a third immediate-release opioid
analgesic product utilizing Acura’s proprietary AVERSION® Technology.
In connection with King's exercise of its option for this third opioid
product, King paid Acura an option exercise fee of $3.0 million. As a
result, Acura and King are now jointly developing three
immediate-release opioid analgesics utilizing Acura’s AVERSION®
Technology.
In June, 2008, Acura announced that clinical
evaluation is now allowed under an active Investigational New Drug
application (“IND”) for a second undisclosed opioid analgesic product
candidate using Aversion® Technology. This product candidate
was previously licensed by Acura to King.
The Company’s future revenue, if any, will
be derived from milestone
and
royalty payments relating to the King Agreement and other milestone and
royalty payments, if any, derived from agreements anticipated to be
potentially negotiated and executed by the Company with other
pharmaceutical company partners. No assurance can be given that the
Company will receive the milestone and royalty payments provided for in
such Agreement, or that the Company will be successful in entering into
similar agreements with other pharmaceutical partners to develop and
commercialize products incorporating the Aversion® Technology.
Commercial Manufacturing of Products
Licensed to King
All opioid products developed pursuant to the King
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 Acurox™ Tablets commercial manufacturing activities.
Acurox™ Tablets utilize a dry blend, direct compression manufacturing
process. This process requires commonly utilized blending and tablet
compression equipment and, compared to other tablet product
formulations, is simple and economical.