BRISTOL, Tenn. and PALATINE, Ill., Dec.
20, 2010 /PRNewswire-FirstCall/ -- King Pharmaceuticals®,
Inc. (NYSE: KG) and Acura Pharmaceuticals, Inc. (Nasdaq: ACUR)
today announced that King has submitted a New Drug Application
(NDA) for ACUROX® (oxycodone HCl) Tablets to the U.S. Food and Drug
Administration (FDA), including a request for priority review
classification. ACUROX® is an immediate release tablet containing
oxycodone HCl intended for the relief of moderate to severe pain.
ACUROX® utilizes Acura's patented Aversion® Technology which is
designed to deter opioid abuse by intravenous injection of
dissolved tablets and nasal snorting of crushed tablets. ACUROX®
does not contain niacin. A separate NDA submission for ACUROX® with
Niacin Tablets is subject to an FDA Complete Response Letter.
Further details on the response to this FDA action letter will be
provided at a later date.
The FDA is expected to determine whether to accept the NDA for
ACUROX® for filing and consider the priority review request within
60 days.
About ACUROX® Tablets
ACUROX® is a patented, orally administered, immediate release
tablet containing oxycodone HCl as its sole active analgesic
ingredient. ACUROX® utilizes Acura's patented Aversion® Technology,
which is a composition of functional inactive ingredients designed
to limit the abuse of dissolved or crushed tablets.
About Aversion® Technology
Aversion® Technology is a patented composition of active and
inactive ingredients intended to relieve moderate to severe pain
and impede potential abuse via nasal snorting of crushed tablets
and intravenous injection of dissolved tablets.
About King Pharmaceuticals®, Inc.
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
and technologies that complement the Company's focus in
specialty-driven markets, particularly neuroscience and hospital.
King's wholly-owned subsidiary, Alpharma, LLC, is also a leader in
the development, registration, manufacture, and marketing of
pharmaceutical products for food-producing animals. On October 11, 2010, King entered into an agreement
and plan of merger with Pfizer Inc. pursuant to which Pfizer agreed
to commence a tender offer to purchase all of the outstanding
shares of common stock of King for $14.25 per share net to the seller in cash. The
tender offer is ongoing.
About Acura Pharmaceuticals, Inc.
Acura Pharmaceuticals, Inc. is a specialty pharmaceutical
company engaged in research, development and manufacture of product
candidates intended to provide abuse deterrent features and
benefits utilizing the Company's proprietary Aversion® and Impede™
Technologies, and other novel technologies. Acura entered into a
License, Development and Commercialization Agreement with King
Pharmaceuticals®, Inc., in October
2007 pursuant to which Acura and King are now jointly
developing ACUROX® Tablets and three additional opioid analgesic
product candidates utilizing Aversion® Technology.
Related Links:
http://www.KingPharm.com
http://www.AcuraPharm.com
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
(the "Act"). When used in this press release, the words
"intend," "expect," "believe" and similar expressions are intended
to identify forward-looking statements. Examples of forward-looking
statements in this press release include statements concerning,
among other items: the Companies' expectations regarding their
interaction with the FDA; whether and when the FDA accepts the
filing of the NDA for ACUROX®; the FDA's consideration of a
priority review classification of the NDA for ACUROX®; and the
abuse deterrent capabilities of ACUROX® and Aversion® Technology.
Acura Pharmaceuticals, Inc. and King Pharmaceuticals®, Inc.
disclaim any intent or obligation to update these forward-looking
statements, and claim the protection of the Safe Harbor for
forward-looking statements contained in the Act. Such
forward-looking statements involve known and unknown risks,
uncertainties and other factors which may cause actual results,
performance or achievements to be materially different from any
future results, performance, or achievements expressed or implied
by such forward-looking statements. 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 the Companies' Annual Reports on Form 10-K for the
fiscal year ended December 31, 2009,
and their Quarterly Reports on Form 10-Q for the quarter ended
September 30, 2010, each of which is
on file with the U.S. Securities and Exchange Commission.
ADMINISTRATIVE OFFICES
KING PHARMACEUTICALS®, INC.
501 FIFTH STREET, BRISTOL,
TN 37620
ACURA PHARMACEUTICALS, INC.
616 N. NORTH COURT,
PALATINE, IL 60067
IMPEDE is a trademark and ACUROX and AVERSION are registered
trademarks of Acura Pharmaceuticals, Inc.
King Pharmaceuticals
Contacts:
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Jack Howarth, Vice President,
Investor Relations
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908-429-8350
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Acura Pharmaceuticals
Contact:
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Peter Clemens, Senior Vice
President and Chief Financial Officer
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847-705-7709
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Media
Contact:
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Laurie Masonson, Ruder Finn,
Inc.
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212-583-2793
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SOURCE King Pharmaceuticals(R), Inc.; Acura Pharmaceuticals,
Inc.