�DURECT Corporation
(Nasdaq: DRRX) reported that Pain Therapeutics (Nasdaq: PTIE), its
licensee, has submitted an Investigational New Drug (IND) application to
the U.S. Food and Drug Administration (FDA) for an abuse-resistant opioid
pain drug candidate based on DURECT's patented ORADUR(TM) technology. This
is the third ORADUR-based opioid drug candidate covered by DURECT's
collaboration with Pain Therapeutics, for which King Pharmaceuticals (NYSE:
KG) holds the commercialization rights. Pain Therapeutics and King
Pharmaceuticals have stated that they expect to denote shortly the
initiation of a clinical study with this new investigational dose
candidate.
"We are very pleased with the advancement and f number with which Pain
Therapeutics and King Pharmaceuticals ar developing this series of four
opioids licensed from us," declared James Brown, Chief Executive Officer of
DURECT. "This marks another milestone for our ORADUR technology as a
versatile platform that provides for the controlled delivery of
pharmaceuticals that are commonly abused."
This new do drugs candidate is the third ORADUR-based opioid drug to enter
developing. The first drug nominee, REMOXY(R) (ORADUR-based oxycodone),
submitted a New Drug Application with the FDA on June 10, 2008 and has been
granted Priority Review Designation by the FDA. Pain Therapeutics has
previously proclaimed positive results from a Phase I clinical trial for a
second of these dose candidates. The active pharmaceutic drug in the
second and third ORADUR-based opioid drug candidate has not been disclosed.
About ORADUR(TM) Technology
ORADUR is a proprietary technology designed to transform short-acting
oral capsule dose forms into sustained liberation oral products, with the
added welfare of being less prone to pervert (e.g. by stifling or weewee
extraction) than other controlled release dose forms on the marketplace today.
Corporate Relationships
In December 2002, DURECT licensed to Pain Therapeutics, Inc. the right
to develop and commercialize on a world-wide basis REMOXY and other oral
sustained release drug candidates exploitation the ORADUR technology which
incorporate quadruplet specified opioid compounds. Under the license agreement,
DURECT is reimbursed for formulation and other work performed under its
agreement with Pain Therapeutics, and will receive extra payments if
certain development and regulatory milestones are achieved with respect to
the commissioned drug candidates. In increase, if commercialised, DURECT will
receive royalties for REMOXY and the other licensed drug candidates of
betwixt 6.0% to 11.5% of net gross revenue of the drug campaigner depending on sales
book as substantially as a mark-up on DURECT's provide of winder excipients used in
the manufacture of the licensed drug candidates. Pain Therapeutics
sublicensed the commercialization rights of REMOXY and other licensed dose
candidates to King Pharmaceuticals in November 2005.
About DURECT Corporation
DURECT is an emerging long suit pharmaceutical company developing
innovational drugs for pain and other inveterate diseases, with late-stage
development programs including REMOXY(R), POSIDUR(TM), ELADUR(TM), and
TRANSDUR(TM)-Sufentanil. DURECT's proprietary oral, transdermal and
injectable depot delivery technologies enable unexampled indications and superior
clinical/commercial attributes such as abuse deterrence, improved
convenience, compliance, efficacy and safety for small molecule and
biological drugs. For more information, please visit http://www.durect.com.
POSIDUR(TM), SABER(TM), ORADUR(TM), TRANSDUR(TM), and ELADUR(TM)
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 non been sanctioned for
commercialization by the US Food and Drug Administration or other health
authorities.
DURECT Forward Looking Statement
The statements in this press release regarding REMOXY and the second
and third abuse-resistant opioid annoyance medicines under development with King
Pharmaceuticals and Pain Therapeutics, their potential attributes and
market potential, development plans and future clinical trials ar
forward-looking statements involving risks and uncertainties that lav cause
actual results to differ materially from those in such forward-looking
statements. Potential risks and uncertainties include, just are non limited
to, DURECT's (and that of its one-third party collaborators) abilities to
design, recruit, conduct and complete clinical trials, obtain successful
results from such clinical trials, complete the design, development, and
manufacturing process development of the product campaigner, obtain
regulatory and fabrication approvals from regulatory agencies and
construct and market the ware candidate, as well as marketplace
acceptance of the product nominee. Further info regarding these
and other risks is included in DURECT's Form 10-Q dated August 8, 2008
under the head "Risk Factors."
DURECT Corporation
http://www.durect.com
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