BRISTOL, Tenn. and SAN MATEO, Calif., Dec.
27, 2010 /PRNewswire/ -- King Pharmaceuticals®, Inc. (NYSE:
KG) and Pain Therapeutics®, Inc. (Nasdaq: PTIE) today announced
that King has resubmitted a New Drug Application (NDA) for REMOXY®
(oxycodone) to the U.S. Food and Drug Administration (FDA) in
response to a Complete Response letter received by Pain
Therapeutics in December 2008.
This is a Class 2 resubmission with a six month review
cycle.
REMOXY® is a twice daily, long-acting formulation of oral
oxycodone for moderate to severe pain requiring continuous,
around-the-clock opioid treatment for an extended period of time.
REMOXY® was developed by Pain Therapeutics, using DURECT
Corporation's (Nasdaq: DRRX) ORADUR® technology, to help address
the growing problem of non-medical use of prescription opioids.
REMOXY® is comprised of a high-viscosity, liquid formulation
in a hard gelatin capsule that is designed to provide steady,
around-the-clock pain relief, while resisting common methods of
tampering intended to result in the rapid release of oxycodone.
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 Pain Therapeutics®, Inc.
Pain Therapeutics®, Inc. is a biopharmaceutical company
that develops novel drugs. In addition to REMOXY®, the Company has
three other drug candidates in clinical programs. These include a
novel monoclonal antibody-based treatment against metastatic
melanoma. The Company is also developing a new treatment for
patients with hemophilia, a genetic disorder in which patients are
unable to stop bleeding.
Related links:
http://www.KingPharm.com
http://www.PainTrials.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 the FDA's
review of the REMOXY® NDA and the tamper-resistance capabilities of
REMOXY® and ORADUR® Technology. King Pharmaceuticals®, Inc. and
Pain Therapeutics®, 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 each 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.
EXECUTIVE OFFICES
KING PHARMACEUTICALS®, INC.
501 FIFTH STREET, BRISTOL,
TN 37620
PAIN THERAPEUTICS®, INC.
2211 BRIDGEPOINTE PARKWAY, SUITE 500, SAN MATEO, CA 94404
REMOXY® is a registered trademark of Pain Therapeutics®,
Inc.
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King Pharmaceuticals
Contact:
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Jack Howarth, Vice President,
Investor Relations
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908-429-8350
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Pain Therapeutics
Contact:
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Judy Ishida, Administrative
Manager
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650-645-1924
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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.
