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.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.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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