CUPERTINO, Calif., Jan. 29 /PRNewswire-FirstCall/ — DURECT Corporation
(Nasdaq: DRRX) announced today that we have entered into a long term
manufacturing and supply agreement with Hospira Worldwide, Inc. (“Hospira”)
(NYSE: HSP) for POSIDUR(TM), DURECT’s post-surgical pain management
investigational drug which is currently in Phase II clinical trials. Under
the agreement, Hospira’s One 2 One(R) contract manufacturing services will
provide DURECT’s clinical and commercial supplies of POSIDUR on a worldwide
basis. The two parties have begun manufacturing development activities in
accordance with the agreement.
(Logo: http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO)
“Hospira’s capabilities, expertise and capacity in manufacturing
parenteral products makes them an ideal partner for us, and the establishment
of this agreement, following on the heels of our recent development and
commercialization collaboration with Nycomed, now one of the 25 largest
pharmaceutical companies in the world as a result of its Altana acquisition,
is a second key milestone in our POSIDUR development program,” said James
Brown, Chief Executive Officer of DURECT.
“We look forward to supporting DURECT’s manufacturing needs to help them
bring POSIDUR to market around the world,” said Anthony Cacich, Vice President
and General Manager, Contract Manufacturing Services, Hospira. “Our
collaboration with DURECT exemplifies how Hospira One 2 One partners with its
clients from development to commercialization to deliver quality parenteral
products and leading-edge technologies to market.”
POSIDUR (SABER(TM)-Bupivacaine) is a long-acting local anesthetic under
development by DURECT for the treatment of post-surgical pain. It is intended
to be injected during surgery, where it continuously releases therapeutic
levels of bupivacaine in a controlled fashion, providing up to 72 hours of
uninterrupted local analgesia. POSIDUR’s performance is due to DURECT’s
proprietary SABER delivery system, which is an injectable, biodegradable drug
delivery technology that allows for less post-injection burst than is typical
of polymer-based systems. On November 29, 2006, DURECT and Nycomed signed a
$202 million agreement to develop and commercialize POSIDUR in Europe and
other select countries. POSIDUR is currently in Phase II clinical development.
DURECT and Nycomed anticipate moving the program into Phase III in 2007.
About DURECT Corporation
DURECT Corporation is an emerging specialty pharmaceutical company focused
on the development of pharmaceutical systems based on its proprietary drug
delivery platform technologies focused on treating chronic and episodic
diseases and conditions. The Company currently has a number of late-stage
pharmaceutical products in development initially focused on significant unmet
medical needs in pain management, with a number of research programs underway
in a variety of other therapeutic areas. For more information, please visit
http://www.www.durect.com.
About Hospira
Hospira is a global specialty pharmaceutical and medication delivery
company dedicated to Advancing Wellness(TM) by developing, manufacturing and
marketing products that help improve the productivity, safety and efficacy of
patient care. With 70 years of service to the hospital industry, Hospira’s
portfolio includes one of the industry’s broadest lines of generic acute-care
injectables, which help address the high cost of proprietary pharmaceuticals;
integrated solutions for medication management and infusion therapy; and the
leading U.S. injectable contract manufacturing business. Headquartered north
of Chicago in Lake Forest, Ill., Hospira has approximately 13,000 employees
and 14 manufacturing facilities worldwide. Hospira’s news releases and other
information can be found at http://www.hospira.com.
Forward-Looking Statement
The statements in this press release regarding POSIDUR, obtaining clinical
and commercial supplies of POSIDUR, and DURECT’s development plans and future
clinical trials for POSIDUR 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 and Nycomed’s abilities to design, enroll,
conduct and complete clinical trials, obtain successful results from such
clinical trials, complete the design, development, and manufacturing process
development of POSIDUR, obtain regulatory and manufacturing approvals from
regulatory agencies and manufacture and commercialize POSIDUR, as well as
marketplace acceptance of POSIDUR. Further information regarding these and
other risks is included in DURECT’s Form 10-Q dated November 3, 2006 under the
heading “Risk Factors.”
NOTE: POSIDUR(TM) and SABER(TM) are trademarks of DURECT Corporation.
POSIDUR is under development and has not been submitted or approved for
commercialization by the US Food and Drug Administration or other health
authorities.
SOURCE DURECT Corporation
-0- 01/29/2007
/CONTACT: Schond L. Greenway, Vice President, Investor Relations and
Strategic Planning of DURECT Corporation, +1-408-777-1417; or Jeremiah Hall,
Senior Vice President of Feinstein Kean Healthcare, +1-415-677-2700,
jeremiah.hall@fkhealth.com, for DURECT Corporation/
/Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, photodesk@prnewswire.com/
/Web site: http://www.www.durect.com/
(DRRX HSP)
CO: DURECT Corporation; Hospira
ST: California
IN: BIO MTC
SU: CON
JB-AH
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