CUPERTINO, Calif., May 8, 2017 /PRNewswire/ -- DURECT Corporation
(Nasdaq: DRRX) today announced a development and commercialization
agreement with Sandoz AG, a division of Novartis (NYSE: NVS), to
develop and market in the United
States DURECT's POSIMIR®
(SABER®-Bupivacaine), an investigational locally-acting,
non-opioid analgesic intended to provide up to three days of
continuous pain relief after surgery.
Sandoz is a global leader in driving sustainable access to
high-quality healthcare. Sandoz's differentiated product
portfolio includes a range of state-of-the-art technologies,
formulations and devices. In the U.S., Sandoz Inc. has a dedicated
hospital sales and marketing organization, with expertise and
relationships, which will be employed to deliver POSIMIR to the
market.
"We are delighted to collaborate with a company with the market
presence and resources of Sandoz to commercialize POSIMIR in
the United States," said
James E. Brown, president and CEO of
DURECT Corporation. "We believe that POSIMIR has the potential to
become a cornerstone of multi-modal post-operative pain management.
As a non-opioid local analgesic, we believe POSIMIR may be an
important contributor to the on-going efforts to reduce the use of
opioid-based medications following surgery."
Under the terms of the agreement, Sandoz will make an upfront
payment to DURECT of $20 million,
with the potential for up to an additional $43 million in development and regulatory
milestones, up to an additional $230
million in sales based milestones, as well as a tiered
double digit royalty on product sales in the United States. DURECT will remain
responsible for the completion of the ongoing PERSIST Phase 3
clinical trial for POSIMIR as well as FDA interactions through
approval. Closing of the transaction is anticipated to occur in the
second quarter of 2017 and is contingent on completion of review
under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of
1976.
About POSIMIR® (SABER-Bupivacaine)
POSIMIR is an investigational extended-release depot utilizing
DURECT's patented SABER technology intended to continuously deliver
bupivacaine to the surgical site for 72 hours, to provide up to
three days of continuous pain relief after surgery. DURECT is
currently conducting PERSIST, a Phase 3 trial in patients
undergoing laparoscopic cholecystectomy (gall bladder removal),
comparing the effects of POSIMIR to bupivacaine HCl. DURECT expects
to complete dosing patients in PERSIST in the third quarter of 2017
and to have top-line results soon thereafter. POSIMIR is a drug
candidate under development and has not been approved for
commercialization by the U.S. Food and Drug Administration or other
health authorities.
About DURECT
DURECT is a biopharmaceutical company actively developing new
therapeutics based on its Epigenetic Regulator Program and
proprietary drug delivery platforms. DUR‑928, a new chemical entity
in Phase 1 development, is the lead candidate in DURECT's
Epigenetic Regulator Program. An endogenous, orally bioavailable
small molecule, DUR-928 has been shown in preclinical studies to
play an important regulatory role in lipid homeostasis,
inflammation, and cell survival. Human applications may include
acute organ injury and chronic metabolic diseases such as
nonalcoholic fatty liver disease (NAFLD), nonalcoholic
steatohepatitis (NASH) and other liver diseases both broad and
orphan. DURECT's advanced oral, injectable, and transdermal
delivery technologies are designed to enable new indications and
enhanced attributes for small-molecule and biologic drugs. One
late-stage product candidate in this category is
POSIMIR® (SABER®-Bupivacaine), an
investigational locally-acting, non-opioid analgesic intended to
provide up to three days of continuous pain relief after
surgery. Another late stage product candidate is
REMOXY® ER (oxycodone), an investigational pain control
drug based on DURECT's ORADUR® technology. For more
information, please visit www.durect.com.
NOTE: POSIMIR®, SABER®, and
ORADUR® are trademarks of DURECT Corporation. Other
referenced trademarks belong to their respective owners. POSIMIR,
DUR-928, and REMOXY ER are drug candidates under development and
have not been approved for commercialization by the U.S. Food and
Drug Administration or other health authorities.
DURECT Forward-Looking Statement
The statements in this press release regarding the potential
benefits and uses of our drug candidates, including the potential
use of POSIMIR to treat post-surgical pain, the anticipated timing
of the enrollment of the PERSIST trial and the obtaining of
top-line results from that trial, the potential milestone payments
and royalties receivable from Sandoz, the potential use of DUR-928
to treat NASH, other liver diseases or acute organ injury,
and potential markets for POSIMIR and DUR-928, 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, the risks that the PERSIST clinical trial of POSIMIR
will take longer to conduct than anticipated or result in data that
will not support a successful NDA resubmission or product approval,
failure to achieve the performance milestones or commercial sales
that trigger the referenced payments or royalties, possible adverse
events associated with the use of POSIMIR, delays and costs due to
additional work or other requirements imposed by regulatory
agencies for continued development, approval or sale of POSIMIR,
our ability to manufacture, commercialize and obtain marketplace
acceptance of POSIMIR, and avoid infringing patents held by other
parties and secure and defend patents of our own, and risks related
to our ability to obtain capital to fund operations and expenses.
Further information regarding these and other risks is included in
DURECT's Form 10-K filed on March 29,
2017 under the heading "Risk Factors."
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SOURCE DURECT Corporation