CUPERTINO, Calif., Nov. 29 /PRNewswire-FirstCall/ — DURECT Corporation
(Nasdaq: DRRX) announced today the signing of a collaboration agreement with
Nycomed, a privately held European pharmaceutical company headquartered in
Denmark, whereby the companies will jointly develop DURECT’s POSIDUR(TM)
post-operative pain relief depot. Nycomed will have exclusive
commercialization rights in Europe and other select countries, and DURECT will
retain full ownership of POSIDUR in the U.S., Canada, Asia and other
countries.
“We believe that POSIDUR has the potential to play a major role in
addressing post-surgical pain,” stated Hakan Bjorklund, Chief Executive
Officer of Nycomed. “The strategy of employing local post-surgical pain
management to reduce the need for systemic pain relief is consistent with
current trends to reduce the use of narcotics and associated side effects, as
well as hospital stays and associated costs.”
“Nycomed has an extensive hospital-based salesforce and will provide a
dedicated salesforce to promote POSIDUR, which complements Nycomed’s existing
portfolio of pain management and hospital products,” stated James Brown,
President and CEO of DURECT. “In addition, this collaboration furthers our
objective to become a specialty pharmaceutical company by our retention of
commercialization rights in the U.S., as well as other significant
territories, while reducing the cost of funding our U.S. development program
for POSIDUR by the shared funding with Nycomed of a common development program
for the U.S. and Europe.”
Under the terms of the agreement, Nycomed will pay DURECT an upfront
license fee of $14 million, with additional milestone payments of up to $188
million upon achievement of defined development, regulatory and sales
milestones. The two parties will jointly direct and equally fund a
development program for POSIDUR intended to secure regulatory approval in both
the U.S. and the European Union (E.U.). DURECT has licensed Nycomed the
exclusive commercialization rights to POSIDUR(TM) in the E.U. and select other
countries. In addition, DURECT will manufacture and supply the product to
Nycomed for commercial sale in the territory licensed to Nycomed. Nycomed will
pay DURECT blended royalties on sales in the defined territory of 15-40%
depending on annual sales.
Conference Call Information
DURECT Corporation will be hosting a conference call to discuss this
announcement on November 29, 2006 at 4:30 PM Eastern Standard Time. To
participate in the conference call, please dial in to (800) 254-0499
(domestic) or (408) 960-7131 (international) and request the “DURECT Corporate
Event,” entry code 5020. Please dial in 10 minutes prior to the scheduled
start time. A replay of the call will be available for 24 hours. The replay
dial-in number within the US is 1-877-519-4471 (Reservation#: 8179161). The in
international replay dial-in number is 1-973-341-3080. The conference call is
also available live over the Internet.
About POSIDUR
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. 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
www.www.durect.com.
About Nycomed
Nycomed is a pharmaceutical company dedicated to meeting medical needs in
Europe. The company provides hospital products throughout the region and
general practitioner and pharmacy medicines in selected markets. New products
are sourced through licensing agreements with research companies, in which
case Nycomed typically provides late-stage clinical development, registration
and marketing. Headquartered in Roskilde, Denmark, the company employs about
3,500 people throughout Europe and Russia-Commonwealth of Independent States
(CIS). Nycomed is privately owned and had a 2005 net turnover of euro 748
million. For more information, visit www.nycomed.com.
DURECT Forward-Looking Statement
The statements in this press release regarding POSIDUR, its potential
attributes and market potential, DURECT’s development plans and future
clinical trials for POSIDUR and the milestone and royalty payments and other
consideration that may be potentially received by DURECT under the
collaboration 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
11/29/2006
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, or
jeremiah.hall@fkhealth.com
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Web site: http://www.www.durect.com
http://www.nycomed.com
(DRRX)