CUPERTINO, Calif., Oct. 23 /PRNewswire/ — DURECT Corporation
(Nasdaq: DRRX) today announced that it has commenced construction of a
commercial manufacturing facility that is expected to meet DURECT’s production
needs for Phase III clinical trials currently planned for late 2001 and
commercial market supply for its lead product, DUROS sufentanil. The new
facility will comprise approximately 8,000 square feet and will be located at
DURECT’s headquarters in Cupertino, CA. The facility will house a
state-of-the-art cleanroom space and an advanced manufacturing process capable
of supporting clean assembly and aseptic filling operations. The facility is
expected to have sufficient manufacturing capacity to provide commercial
quantities of DURECT’s lead product for the treatment of chronic pain, as well
as provide pilot/clinical supplies for additional products under development
by the company.
“We are pleased to reach this important milestone. This facility will
allow us to commercially develop therapies that will improve the quality of
life for patients with chronic diseases and conditions. Our pharmaceutical
systems can improve patients’ quality of life by eliminating more repetitive
treatments, reducing dependence on caregivers and allowing them to lead more
independent lives,” says Jim Brown, President and CEO, at the CIBC World
Markets 11th Annual Healthcare Conference in New York City, NY. Dr. Brown’s
presentation will be available for replay on DURECT’s website under “Investor
Relations” for a period of one week after the conference.
DURECT’s lead product, DUROS sufentanil, will target patients with chronic
pain that is stable, opioid responsive and results from a variety of causes.
DUROS sufentanil will provide an alternative to current therapies for the
treatment of chronic pain, as well as ensuring improved patient compliance and
convenience.
DURECT Corporation is pioneering the development and commercialization of
pharmaceutical systems that will deliver the right drug to the right site in
the right amount at the right time. DURECT’s pharmaceutical systems combine
technology innovations from the medical device and drug delivery industries
with proprietary pharmaceutical and biotechnology drug formulations. These
capabilities can enable new drug therapies or optimize existing therapies
based on a broad range of compounds, including small molecule pharmaceuticals
as well as biotechnology molecules such as proteins, peptides and genes.
DURECT’s initial portfolio of products combine the DUROS technology, a proven
and patented drug delivery platform licensed for specified fields of use from
ALZA Corporation, with drugs for which medical data on efficacy and safety are
available. Founded in 1998, the Company is headquartered in Cupertino, CA. The
Company’s World Wide Web site can be accessed at http://www.www.durect.com. To
join DURECT’s email alert service, please register by selecting “Email Alerts”
on the main Investor Relations web page at http://www.www.durect.com.
DUROS is a registered trademark of ALZA Corporation.
The statements in this press release regarding DURECT’s products in
development, product development plans, clinical trials, and expected product
benefits are forward-looking statements involving risks and uncertainties that
could 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 develop, manufacturer and commercialize
its products, complete successful clinical trials, obtain product approvals
from regulatory agencies, build a manufacturing facility and marketplace
acceptance of DURECT’s products. Further information regarding these and other
risks is included in the company’s S-1 registration statement, filed with the
SEC on September 22, 2000 and its 424(b) prospectus filed with the SEC on
September 28, 2000.
For further information please contact:
DURECT Corporation Noonan/Russo Communications
Schond L. Greenway Tom Baker
Director, Investor Relations Media Relations
Phone: (408) 777-1417 Phone: (415) 677-4455 Ext. 370
schond.greenway@durect.com t.baker@noonanrusso.com