CUPERTINO, Calif., Aug. 27 — 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.
“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.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