CUPERTINO, Calif., Nov 16, 2001 /PRNewswire via COMTEX/ — DURECT Corporation
(Nasdaq: DRRX) announced today that ALZA Corporation has exercised its option to
allow ALZA and Janssen Pharmaceutica Products, L.P., the right to begin
negotiations for exclusive sales and marketing rights to DURECT’s lead pain
management product, Chronogesic(TM) for the U.S. and Canada. Chronogesic(TM) is
intended to treat patients with stable, opioid responsive chronic pain.
Under the revised terms of the option agreed to by ALZA and DURECT, DURECT and
Janssen will engage in negotiations for a defined period of time towards an
agreement for the commercialization of Chronogesic(TM) in the United States and
Canada. All commercialization rights will revert to DURECT should the parties
not reach an agreement after such exclusive period of negotiations.
“We are pleased with the interest that ALZA and Janssen have shown in the
marketing opportunity of Chronogesic(TM). We at DURECT believe that,
Chronogesic(TM) may represent a tremendous opportunity for physicians and
patients with chronic pain,” said James Brown, CEO of DURECT.
As previously announced by DURECT’s management, ALZA and Janssen continue to
evaluate the commercial potential and product attributes of Chronogesic(TM)
since the completion of DURECT’s Phase II clinical trials for that product.
DURECT recently announced completion of patient enrollment and treatment in a
pilot Phase III clinical trial and expects to initiate pivotal Phase III
registration trials next year.
DURECT Corporation 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.
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 focuses on the treatment of chronic
diseases including pain, CNS disorders, cardiovascular disease and cancer.
DURECT holds an exclusive license from ALZA Corporation to develop and
commercialize products in selected fields based on ALZA’s DUROS(R) implant
technology. Chronogesic(TM), a 3-month continuous infusion subcutaneous implant
that is under investigation for the treatment of chronic pain, is the first
product in this series and completed phase II testing in June 2001. DURECT also
owns three proprietary erodible implant platform technologies, including
SABER(TM) (a patented and versatile depot injectable useful for protein
delivery), microspheres and drug-loaded implants. DURECT also commercializes
IntraEAR(R) catheters, which have been used by physicians to treat inner ear
disorders.
Founded in 1998, DURECT 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 .
NOTE: Chronogesic(TM), SABER(TM) and IntraEAR(R) are trademarks of DURECT
Corporation. DUROS(R) is a registered trademark of ALZA Corporation.
The statements in this press release regarding DURECT’s clinical trials, product
commercialization plans, anticipated results, products in development, expected
product benefits, product development plans, potential product markets or
potential commercialization agreements, including the potential for the
exclusive negotiations on Chronogesic(TM) to result in a definitive agreement,
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 successfully conclude agreements with third parties,
including ALZA and Janssen, complete clinical trials, research, develop,
manufacture and commercialize its products, obtain product and manufacturing
approvals from regulatory agencies, validate and qualify a manufacturing
facility and manage its growth and expenses, as well as marketplace acceptance
of DURECT’s products. Further information regarding these and other risks is
included in DURECT’s Quarterly Report on Form 10-Q for the quarter ended June
30, 2001 filed with the SEC on August 14, 2001, and Annual Report on Form 10-K
for the fiscal year ended December 31, 2000 filed with the SEC on March 30,
2001, under the heading “Factors that may affect future results.”
Chronogesic(TM) 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.
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SOURCE DURECT Corporation
CONTACT: Schond L. Greenway, Senior Director, Investor Relations and
Strategic Planning of DURECT Corporation, +1-408-777-1417, or
schond.greenway@durect.com
URL: http://www.www.durect.com
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