DURECT Initiates Manufacture of Clinical Product for its CHRONOGESIC(R) (Sufentanil) Pain Therapy Product

Download PDF:

CUPERTINO, Calif., Oct 9, 2003 /PRNewswire-FirstCall via COMTEX/ — DURECT Corporation
(Nasdaq: DRRX) today announced that it has initiated manufacture of clinical
product for its anticipated pharmacokinetic study and other initial clinical
studies in the Phase III program for its CHRONOGESIC(R) (sufentanil) Pain
Therapy product using the Company’s new terminal sterilization manufacturing

(Logo: http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO )

“Today, we are pleased to report that we have started the manufacture of
product to supply the initial clinical trials for our CHRONOGESIC product.
This is an important milestone for our CHRONOGESIC program,” stated James E.
Brown, DVM, President and CEO of DURECT. “The credit for this accomplishment
is due to the experience, ingenuity and hard work of our employees who are
committed to the development of a much needed product to treat patients
suffering from chronic pain. Going forward, we intend to continue executing on
our plans to complete the tasks necessary to move our CHRONOGESIC product back
into the clinic.”

The CHRONOGESIC product is intended to target patients with opioid
responsive chronic pain that results from a variety of causes. The CHRONOGESIC
product is designed to deliver sufentanil continuously for three months of
pain therapy. Sufentanil is an opioid that is currently used in hospitals as
an analgesic agent. Chronic pain is a significant problem associated with
chronic diseases, including cancer and various neurological and skeletal
disorders. Chronic nonmalignant pain affects as many as 34 million Americans
annually. In addition, the National Cancer Institute estimates that 8.4
million Americans alive today have a history of cancer. Sales of opioids for
the treatment of malignant and nonmalignant pain currently exceed $3 billion.

DURECT Corporation (www.www.durect.com) is pioneering the development and
commercialization of pharmaceutical systems for the treatment of chronic
debilitating diseases and enabling biotechnology-based pharmaceutical
products. DURECT’s goal is to deliver the right drug to the right site in the
right amount at the right time. In addition to its rights to the
CHRONOGESIC(R) product, DURECT owns three proprietary drug delivery platform
technologies, including the SABER(TM) Delivery System (a patented and
versatile depot injectable useful for protein delivery), the MICRODUR(TM)
Biodegradable Microparticulates (microspheres injectable system) and the
DURIN(TM) Biodegradable Implant (drug-loaded implant system).

trademarks of DURECT Corporation.

The statements in this press release regarding DURECT’s products in
development and product development 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 DURECT’s products. Further
information regarding these and other risks is included in DURECT’s Annual
Report on Form 10-K for the fiscal year ended December 31, 2002 filed with the
SEC on March 14, 2003, DURECT’s Quarterly Report on Form 10Q and other
periodic reports filed with the SEC under the heading “Factors that may affect
future results.”

CHRONOGESIC is under development by DURECT and has not been submitted or
approved for commercialization by the US Food and Drug Administration or other
health authorities.


Schond L. Greenway
Senior Director, Investor Relations and
Strategic Planning of DURECT Corporation
/Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, +1-888-776-6555 or +1-212-782-2840


Scroll to Top