LAKE FOREST, Ill. , and
CUPERTINO, Calif., June 7 /PRNewswire-FirstCall/ -- Hospira, Inc.
(NYSE: HSP), a global specialty pharmaceutical and medication
delivery company, and DURECT Corporation, a specialty
pharmaceutical company (Nasdaq: DRRX), today announced that the
companies have entered into a licensing agreement to develop and
market DURECT's POSIDUR™ (SABER™-bupivacaine) a long-acting version
of the anesthetic bupivacaine currently in Phase III clinical
trials. Hospira will co-develop the drug and would have exclusive
marketing rights in the United
States and Canada following
regulatory approval.
Under terms of the agreement, Hospira will make an upfront
payment of $27.5 million, with the
potential for up to an additional $185
million in performance milestone payments based on the
successful development, approval and commercialization of
POSIDUR. For the U.S. and Canada, the two companies will jointly direct
and equally fund the remaining development costs, while Hospira
will have exclusive commercialization rights with sole funding
responsibility. In addition, Hospira will pay DURECT a
royalty on product sales.
POSIDUR is designed to provide up to 72 hours of anesthetic
directly at the site of a surgical wound, with the potential to
reduce post-surgical pain and allow earlier patient mobility and
hospital discharge. Phase III trials are expected to be completed
in 2011. Bupivacaine is a widely used generic anesthetic currently
marketed by Hospira as well as other companies.
"This partnership with DURECT provides Hospira with U.S. and
Canadian rights to an exciting new product that will bolster our
leadership position in acute-care proprietary pharmaceuticals,"
said Andrew Robbins, vice president,
Corporate Development and Proprietary Pharmaceuticals, Hospira.
"POSIDUR is being developed to improve post-surgical recovery,
which represents a good fit with our vision of advancing wellness
for patients."
"This collaboration builds on the relationship we've had with
Hospira for several years as our manufacturer of POSIDUR," stated
James E. Brown, president and chief
executive officer of DURECT Corporation. "We believe that POSIDUR
has the potential to play a significant role in treating
post-surgical pain, reducing the need for systemic narcotic pain
relief and associated side effects, as well as costs associated
with lengthy hospital stays."
From a commercial perspective, POSIDUR will be complementary
with Precedex™, Hospira's proprietary sedation agent, which is
currently marketed in the hospital through a dedicated acute-care
sales force.
About Hospira
Hospira, Inc. is a global specialty pharmaceutical and
medication delivery company dedicated to Advancing Wellness™. As
the world leader in specialty generic injectable pharmaceuticals,
Hospira offers one of the broadest portfolios of generic acute-care
and oncology injectables, as well as integrated infusion therapy
and medication management solutions. Through its products, Hospira
helps improve the safety, cost and productivity of patient care.
The company is headquartered in Lake
Forest, Ill., and has approximately 13,500 employees. Learn
more at www.hospira.com.
About DURECT
DURECT is an emerging specialty pharmaceutical company
developing innovative drugs for pain and other chronic diseases,
with late-stage development programs including REMOXY®, POSIDUR™,
ELADUR™, and TRANSDUR™-Sufentanil. DURECT's
proprietary oral, transdermal and injectable depot delivery
technologies may enable new indications and superior
clinical/commercial attributes such as abuse deterrence, improved
convenience, compliance, efficacy and safety for small molecule and
biologic drugs. For more information, please visit
www.durect.com.
NOTE: POSIDUR™, SABER™, ORADUR®, TRANSDUR™, and ELADUR™ are
trademarks of DURECT Corporation. Other referenced trademarks
belong to their respective owners. REMOXY, POSIDUR, ELADUR
and TRANSDUR-Sufentanil are drug candidates under development and
have not been approved for commercialization by the US Food and
Drug Administration or other health authorities.
Forward-Looking Statements
Hospira
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, including statements related to certain costs and expenses
regarding new product development, and other statements regarding
Hospira's goals and strategy. Hospira cautions that these
forward-looking statements are subject to risks and uncertainties
that may cause actual results to differ materially from those
indicated in the forward-looking statements. Economic, competitive,
governmental, legal, technological and other factors that may
affect Hospira's operations and may cause actual results to be
materially different from expectations include the risks,
uncertainties and factors discussed under the headings "Risk
Factors" and "Management's Discussion and Analysis of Financial
Condition and Results of Operations" in Hospira's latest Annual
Report on Form 10-K and subsequent Forms 10-Q filed with the
Securities and Exchange Commission, which are incorporated by
reference. Hospira undertakes no obligation to release publicly any
revisions to forward-looking statements as the result of subsequent
events or developments.
DURECT
The statements in this press release regarding the potential
uses and benefits of POSIDUR, the anticipated timing of the
completion of the Phase III clinical trial for POSIDUR and
potential milestone payments and royalties receivable from Hospira
hereunder 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 Hospira's difficulty or failure to obtain approvals from
regulatory agencies with respect to its clinical trials and other
development activities, or their respective abilities to design,
enroll, conduct and complete clinical trials, failure of such
clinical trials to produce intended results, failure to achieve the
performance milestones or commercial sales that trigger the
referenced payments or royalties, possible adverse events
associated with the use of POSIDUR, delays and costs due to
additional work or other requirements imposed by regulatory
agencies for continued development, approval or sale of POSIDUR,
our ability to complete the design, development, and manufacturing
process development of POSIDUR, and to manufacture, commercialize
and obtain marketplace acceptance of POSIDUR, and avoid infringing
patents held by other parties and secure and defend patents of our
own, and manage and obtain capital to fund our growth, operations
and expenses. Further information regarding these and other risks
is included in DURECT's Form 10-Q filed on May 10, 2010 under the heading "Risk
Factors."
SOURCE Hospira, Inc.