King Pharmaceuticals and Pain Therapeutics Announce Resubmission of New Drug Application for REMOXY(R)
December 27 2010 - 8:30AM
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.
CONTACT: King Pharmaceuticals:
Jack Howarth, Vice President, Investor Relations
908-429-8350
Pain Therapeutics:
Judy Ishida, Administrative Manager
650-645-1924
Ruder Finn, Inc.
Media Contact:
Laurie Masonson
212-583-2793
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