CUPERTINO, Calif., Aug 27, 2008 /PRNewswire-FirstCall via COMTEX News Network/ — DURECT Corporation
(Nasdaq: DRRX) today 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 announce shortly the initiation of a clinical study
with this new investigational drug candidate.
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“We are very pleased with the progress and speed with which Pain
Therapeutics and King Pharmaceuticals are developing this series of four
opioids licensed from us,” stated 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 drug candidate is the third ORADUR-based opioid drug to enter
development. The first drug candidate, 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 announced positive results from a Phase I clinical trial for a
second of these drug candidates. The active pharmaceutical 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 dosage forms into sustained release oral products, with the added
benefit of being less prone to abuse (e.g. by crushing or water extraction)
than 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 with Pain
Therapeutics, 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.
About DURECT Corporation
DURECT is an emerging specialty pharmaceutical company developing
innovative drugs for pain and other chronic 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 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 http://www.www.durect.com.
NOTE: 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 not been approved 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 pain medicines under development with King
Pharmaceuticals and Pain Therapeutics, their potential attributes and market
potential, development plans and future clinical trials 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, DURECT’s (and that of
its third party collaborators) abilities to design, enroll, conduct and
complete clinical trials, obtain successful results from such clinical trials,
complete the design, development, and manufacturing process development of the
product candidate, obtain regulatory and manufacturing approvals from
regulatory agencies and manufacture and commercialize the product candidate,
as well as marketplace acceptance of the product candidate. Further
information regarding these and other risks is included in DURECT’s Form 10-Q
dated August 8, 2008 under the heading “Risk Factors.”
SOURCE DURECT Corporation
http://www.www.durect.com