CUPERTINO, Calif., Jan. 12 /PRNewswire-FirstCall/ — DURECT Corporation
(Nasdaq: DRRX) today announced its intended clinical and corporate milestones
for the fiscal year 2005.
“These announced milestones are intended to assist the investment
community to track our progress throughout the coming year,” said James E.
Brown, President and CEO of DURECT. “DURECT will continue to drive forward our
development programs in 2005 to build lasting value for our shareholders.”
Anticipated Development Program Milestones
Transdermal Sufentanil Pain Product Candidate
— Our transdermal sufentanil product candidate (significantly smaller
than the size of currently marketed transdermal fentanyl patches for a
therapeutically equivalent dose) is intended to provide extended chronic pain
relief for up to seven days, compared to three days of relief provided by
currently available opiate patches.
— We intend to complete Phase I clinical studies and initiate Phase II
studies during the first half of 2005. We anticipate that Phase II studies
will be completed in the second half 2005.
Post-Operative Pain Depot Product Candidate
— Our post-operative pain relief depot product candidate is a sustained
release injectable designed to provide 2-3 days of post-surgical pain relief
and is based on our patented SABER(TM) delivery system.
— We intend to complete our on-going Phase II trial and announce the
clinical results in the second half of 2005.
Remoxy(TM) (Collaboration with Pain Therapeutics, Inc.)
— Remoxy is a novel long-acting oral formulation of oxycodone based on
DURECT’s ORADUR(TM) technology, a proprietary oral sustained release
technology with several potential abuse deterrent properties.
— We intend to support the ongoing Phase III clinical program conducted
by our commercialization partner, Pain Therapeutics, Inc.
CHRONOGESIC(R) (sufentanil) Pain Therapy Product Candidate (Collaboration
with Endo Pharmaceuticals)
— CHRONOGESIC is a subcutaneous implant that is intended to continuously
deliver sufentanil, an opioid medication, for an extended duration.
— We continue to work on the system design of our CHRONOGESIC product in
order to resume clinical trials for this product.
Alzheimer’s Disease Product Candidate (Collaboration with Voyager
— Our DURIN(TM)-based leuprolide acetate product candidate is intended to
treat patients suffering from Alzheimer’s disease.
— In 2005, Voyager plans to complete the on-going Phase I study with our
— In 2005, Voyager plans to complete its ongoing Phase II study in women
with the active agent and complete an interim analysis of its ongoing Phase II
study in men with the active agent.
— Based on the results of these three studies, Voyager plans to begin
Phase III pivotal studies for our DURIN-leuprolide Alzheimer’s product
candidate during the second half of 2005.
About DURECT Corporation
DURECT Corporation is an emerging specialty pharmaceuticals systems
company focused on the development of pharmaceutical systems based on its
proprietary drug delivery platform technologies that treat chronic
debilitating diseases and enable biotechnology products. These platform
technologies include the SABER(TM) Delivery System (a patented and versatile
depot injectable useful for protein and small molecule delivery), the
ORADUR(TM) sustained release oral gel-cap technology (an oral sustained
release technology with several potential abuse deterrent properties), the
DURIN(TM) Biodegradable Implant (drug-loaded implant system) and the
MICRODUR(TM) Biodegradable Microparticulates (microspheres injectable system).
DURECT also collaborates with pharmaceutical companies to develop and
commercialize proprietary and enhanced pharmaceutical products based on its
technologies. DURECT has five disclosed on-going development programs of which
three are in collaboration with pharmaceutical partners. Additional
information about DURECT is available at www.www.durect.com.
NOTE: SABER(TM), ORADUR(TM), DURIN(TM) and MICRODUR(TM) are trademarks of
DURECT Corporation. Other referenced trademarks belong to their respective
The statements in this press release regarding DURECT’s product
candidates, their designs and intended uses, and DURECT’s and our
collaborators’ product development and clinical trial plans 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
ability to complete the design, development, and manufacturing process
development of its products, manufacture and commercialize its products,
obtain product and manufacturing approvals from regulatory agencies, manage
its growth and expenses, manage relationships with third parties, finance its
activities and operations, as well as marketplace acceptance of these
products. Further information regarding these and other risks is included in
DURECT’s Quarterly Report on Form 10-Q for the quarter ended September 30,
2004 filed with the SEC on November 5, 2004 under the heading “Factors that
may affect future results.”
SOURCE DURECT Corporation
Schond L. Greenway
Executive Director, Investor Relations and
Strategic Planning of DURECT Corporation
Stephanie C. Diaz,
press, Tim Brons,
+1-646-319-8981, or tbrons@vidaLLC.com,
both of Vida Communication, for DURECT
/Web site: http://www.www.durect.com/
01/12/2005 07:30 EST http://www.prnewswire.com