CUPERTINO, Calif., Oct. 16 /PRNewswire-FirstCall/ — DURECT Corporation
(Nasdaq: DRRX) announced today that it has received data from a preclinical
animal test with its CHRONOGESIC(R) (sufentanil) Pain Therapy Product which
indicate that a small number of units (less than 2% in total) utilizing the
new system design under evaluation by the Company experienced a premature
shutdown (stop in delivery of drug).
(Logo: http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO )
In parallel track with the CHRONOGESIC development program using the
current system design, DURECT has been exploring additional mechanisms to
prevent any premature shutdown, and has already generated feasibility data
relating to these mechanisms.
The Company is currently investigating the impact of these new data on the
timing of the development program, but the Company expects that this will
delay the restart of the product’s phase III clinical program previously
anticipated to begin during the second half of 2003.
“We were disappointed to receive these unexpected data from the last of a
series of confirmatory animal studies which just concluded on October 15,”
stated Jim Brown, CEO of DURECT. “We have not observed this phenomenon in any
of our previous studies utilizing the revised system design. We continue to
believe in the value of the CHRONOGESIC program, and we remain committed to
bringing this therapy to the patients.”
Conference Call and Webcast Information
DURECT Corporation will be hosting a conference call on Friday, October
17, 2003 at 8:30 a.m. Eastern Time/5:30 a.m. Pacific Time to discuss these
recent developments. Participants can listen to the conference call via
webcast on the Company’s website, www.www.durect.com.
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).
NOTE: CHRONOGESIC(R), SABER(TM), MICRODUR(TM) and DURIN(TM) are 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.
SOURCE: DURECT Corporation
10/16/2003
CONTACT: Schond L. Greenway, Senior Director, Investor Relations and
Strategic Planning of DURECT Corporation, +1-408-777-1417
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Web site: http://www.www.durect.com