CUPERTINO, Calif., Dec. 27, 2010 /PRNewswire-FirstCall/ -- DURECT
Corporation (Nasdaq: DRRX) today reported that King
Pharmaceuticals, Inc. (NYSE: KG) and Pain Therapeutics, Inc.
(Nasdaq: PTIE) have announced that King has resubmitted a New Drug
Application (NDA) for REMOXY® 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.
(Logo: http://photos.prnewswire.com/prnh/20020717/DRRXLOGO )
REMOXY, based on DURECT's ORADUR® technology, is an
investigational drug that is a unique, controlled release
formulation of oxycodone for moderate-to-severe chronic pain
designed to reduce potential risks of unintended use.
Approximately 50 million Americans suffer from persistent
pain each year, according to the American Pain Foundation.
About ORADUR® Technology
ORADUR is a proprietary technology designed to transform
short-acting oral capsule dosage forms into sustained release oral
products, with the added benefit of resisting common methods of
prescription drug misuse and abuse compared to other controlled
release dosage forms on the market today.
Corporate Relationships
In December 2002, DURECT licensed
to Pain Therapeutics, Inc. the right to develop and commercialize
on a worldwide basis REMOXY and other oral sustained release drug
candidates using the ORADUR technology which incorporate four
specified opioid compounds. Under the license agreement, DURECT is
reimbursed for formulation and other work performed under its
agreement, and will receive additional payments if certain
development and regulatory milestones are achieved with respect to
the licensed drug candidates. In addition, if commercialized,
DURECT will receive royalties for REMOXY and the other licensed
drug candidates of between 6.0% to 11.5% of net sales of the drug
candidate depending on sales volume as well as a mark-up on
DURECT's supply of key excipients used in the manufacture of the
licensed drug candidates. Pain Therapeutics sublicensed the
commercialization rights of REMOXY and other licensed drug
candidates to King Pharmaceuticals in November 2005. In October 2010, Pfizer announced that it had
entered into a definitive merger agreement to acquire King.
Should that transaction be completed, Pfizer would assume the
development and commercialization rights and obligations to REMOXY
and to the other licensed ORADUR-based opioids.
About DURECT Corporation
DURECT is a specialty pharmaceutical company developing
innovative drugs for pain and other chronic diseases, with
late-stage development programs including REMOXY®, POSIDUR™,
ELADUR™, and TRANSDUR™-Sufentanil. DURECT's proprietary oral,
transdermal and injectable depot delivery technologies may enable
new indications and superior clinical/commercial attributes such as
abuse deterrence, improved convenience, compliance, efficacy and
safety for small molecule and biologic drugs. For more
information, please visit www.durect.com.
NOTE: POSIDUR™, SABER™, ORADUR®, TRANSDUR™, and ELADUR™ are
trademarks of DURECT Corporation. Other referenced trademarks
belong to their respective owners. REMOXY, POSIDUR, ELADUR
and TRANSDUR-Sufentanil are drug candidates under development and
have not been approved for commercialization by the U.S. Food and
Drug Administration or other health authorities.
DURECT Forward-Looking Statement
The statements in this press release regarding REMOXY, its
potential attributes and statements related to the potential of FDA
approving the REMOXY NDA, the potential royalty and other payments
that may be received by DURECT from REMOXY and other described
products, and the potential acquisition of King by Pfizer are
forward-looking statements involving risks and uncertainties that
can cause actual results to differ materially from those in such
forward-looking statements. Potential risks and uncertainties
include, but are not limited to, the potential that the REMOXY NDA
resubmission may not be accepted by the FDA or may not adequately
address all of FDA's concerns, the potential that FDA may not grant
regulatory approval of REMOXY, difficulties or delays in the
development, testing, regulatory approval, production and
commercialization of REMOXY, and unexpected adverse side-effects or
inadequate therapeutic efficacy of REMOXY that could slow or
prevent product approval or market acceptance, and that the Pfizer
acquisition of King may not be completed. Further information
regarding these and other risks is included in DURECT's Form 10-Q
dated November 4, 2010 under the
heading "Risk Factors."
SOURCE DURECT Corporation