Attached files
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| 8-K - ACURA PHARMACEUTICALS, INC | v206024_8k.htm |
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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 & Chief Financial
Offficer
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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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King
Pharmaceuticals and Acura Pharmaceuticals Announce
Submission
of New Drug Application for ACUROX®
Tablets
BRISTOL, Tenn. and PALATINE, Ill.,
December 20, 2010 — 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.
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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.
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