DURECT Corporation and ALZA Corporation Amend Licensing Agreement
November 12, 2002
DURECT Corporation (Nasdaq: DRRX) announced today that it has amended its development and commercialization agreement with ALZA Corporation under which DURECT holds exclusive rights to develop, commercialize and manufacture products using ALZA’s patented DUROS® technology in selected fields of use. Under the amended agreement, DURECT’s maintenance of exclusivity in its licensed fields is no longer subject to minimum annual requirements for development spending or the number of products it has under development.
“These changes to the agreement align more closely the interests of DURECT and ALZA and further strengthen the collaboration between the two companies,” said Dr. James Brown, DURECT’s President and CEO. “We believe that this will greatly enhance our ability to focus our resources on the continued development of therapies incorporating the DUROS technology.”
The commercial diligence requirements under the previous agreement were also amended to provide that DURECT retain exclusive commercialization rights to products developed under this Agreement on a worldwide basis as long as DURECT has commercialized such products in selected major market countries. In addition, ALZA and DURECT may collaborate to commercialize selected products under specified terms.
DURECT Corporation (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 November 2001, DURECT completed a pilot phase III program for the CHRONOGESIC™ (sufentanil) Pain Therapy System, a 3-month product for the treatment of chronic pain. DURECT owns three proprietary drug delivery platform technologies, including the SABER™ Delivery System (a patented and versatile depot injectable useful for protein delivery), the MICRODUR™ Biodegradable Microparticulates (microspheres injectable system) and the DURIN™ Biodegradable Implant (drug-loaded implant system).
NOTE: CHRONOGESIC(TM) is a trademark of DURECT Corporation. SABER™, MICRODUR™ and DURIN™ are trademarks of Southern BioSystems, Inc., a wholly owned subsidiary of DURECT Corporation. DUROS® is a registered trademark of ALZA 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 research, develop, manufacture and commercialize its products, obtain product and manufacturing approvals from regulatory agencies, manage its growth and expenses, 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, 2001 filed with the SEC on March 28, 2002, under the heading "Factors that may affect future results," and other periodic reports filed with the SEC. 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