DURECT Signs POSIDUR(TM) Manufacturing Agreement with Hospira
29 Janeiro 2007 - 9:30AM
PR Newswire (US)
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.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.
http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO
http://photoarchive.ap.org/ DATASOURCE: DURECT Corporation 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, , for DURECT Corporation Web site:
http://www.durect.com/
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