CUPERTINO, Calif., Feb. 5 /PRNewswire-FirstCall/ — DURECT Corporation
(Nasdaq: DRRX) announced today that we have entered into a long term
manufacturing and supply agreement with Corium International, Inc. for
TRANSDUR(TM)-Bupivacaine, a transdermal pain patch under development for
patients suffering from Post-Herpetic Neuralgia (post-shingles pain or PHN).
TRANSDUR-Bupivacaine is currently in Phase II clinical trials. Under the
agreement, Corium will provide DURECT’s clinical and commercial supplies of
TRANSDUR-Bupivacaine on a worldwide basis. The two parties have begun
manufacturing development activities in accordance with the agreement.
(Logo: http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO )
“Corium’s flexible capabilities, expertise and collaborative capacity in
manufacturing transdermal products makes them an ideal partner for us, and the
establishment of this relationship is an additional milestone in our TRANSDUR-
Bupivacaine development program,” stated James Brown, Chief Executive Officer
of DURECT.
“We look forward to supporting Durect’s manufacturing needs to help them
bring TRANSDUR-Bupivacaine to market,” said Dr. Gary Cleary, President and
CTO, Corium.
TRANSDUR-Bupivacaine is intended to provide up to 3 days of pain relief
for patients suffering from PHN, as compared to a wearing time limited to 12
hours with currently available patches. DURECT’s Phase I trial for TRANSDUR-
Bupivacaine demonstrated good safety, tolerability and drug release for up to
3 days. DURECT’s Phase II program for TRANSDUR-Bupivacaine has begun with a
randomized, multi-center, double-blind, placebo controlled, two-way crossover
trial in approximately 50 patients with PHN to assess safety as well as the
magnitude, duration and characteristics of analgesic activity of TRANSDUR-
Bupivacaine.
About DURECT Corporation
DURECT Corporation is an emerging specialty pharmaceutical company focused
on the development of pharmaceutical systems based on its proprietary drug
delivery platform technologies focused on treating chronic and episodic
diseases and conditions. The Company currently has a number of late-stage
pharmaceutical products in development initially focused on significant unmet
medical needs in pain management, with a number of research programs underway
in a variety of other therapeutic areas. For more information, please visit
www.www.durect.com.
About Corium International, Inc.
Corium International, Inc. is a privately-owned company engaged in the
research, development and manufacture of advanced transdermal drug delivery
technologies and products. Using its proprietary delivery technologies and
its development and manufacturing expertise, Corium has developed a number of
active and passive transdermal products with enhanced therapeutic or safety
profiles. This self-funded product pipeline spans several therapeutic areas
and is in various stages of development. Corium also has several partner-
funded products under development with small, medium and large pharmaceutical
companies. Please visit www.coriumgroup.com.
Forward-Looking Statement
The statements in this press release regarding TRANSDUR-Bupivacaine, its
potential performance and attributes, obtaining clinical and commercial
supplies of TRANSDUR-Bupivacaine, and DURECT’s development plans and future
clinical trials for TRANSDUR-Bupivacaine 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 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 TRANSDUR-Bupivacaine, obtain regulatory and
manufacturing approvals from regulatory agencies, and manufacture and
commercialize TRANSDUR-Bupivacaine, as well as marketplace acceptance of
TRANSDUR-Bupivacaine. Further information regarding these and other risks is
included in DURECT’s Form 10-Q dated November 3, 2006 under the heading “Risk
Factors.”
NOTE: TRANSDUR(TM) is a trademark of DURECT Corporation. TRANSDUR-
Bupivacaine is under development and has not been submitted or approved for
commercialization by the US Food and Drug Administration or other health
authorities.
SOURCE DURECT Corporation
02/05/2007
CONTACT: Schond L. Greenway, Vice President, Investor Relations and
Strategic Planning of DURECT Corporation, +1-408-777-1417; or Media: Jeremiah
Hall, Senior Vice President of Feinstein Kean Healthcare, +1-415-677-2700, or
jeremiah.hall@fkhealth.com
Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO
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PRN Photo Desk, photodesk@prnewswire.com
Web site: http://www.www.durect.com
http://www.coriumgroup.com
(DRRX)