CUPERTINO, Calif., May 9, 2018 /PRNewswire/ -- DURECT
Corporation (Nasdaq: DRRX) today announced it has entered into an
amendment (the "Amendment") to the development and
commercialization agreement with Sandoz AG, a division of Novartis
(NYSE: NVS), regarding POSIMIR®
(SABER®-bupivacaine) in the
United States.
DURECT received an upfront payment from Sandoz of $20 million at the time the agreement between the
two companies became effective in June
2017 and was initially eligible for up to an additional
$43 million in payments based on
successful development and regulatory milestones (of which
$30 million is feasible following the
results of the PERSIST Phase 3 clinical trial), and up to an
additional $230 million in
sales-based milestones. Sandoz received exclusive
commercialization rights for POSIMIR in the U.S. upon regulatory
approval with sole funding responsibility for commercialization
activities. Sandoz has agreed to pay DURECT a tiered
double-digit royalty on product sales for a defined period.
Pursuant to the amended agreement, DURECT is now eligible for up
to $30 million in milestone payments
based on NDA approval, and remains eligible for up to an additional
$230 million in sales-based
milestones. Each party, pursuant to the Amendment, is also
permitted to develop or commercialize competing products. The
Amendment also includes modifications to DURECT's development
obligations and to both parties' termination provisions, including
a right for DURECT to terminate for convenience prior to NDA
approval. There is also a new termination fee payable to DURECT in
the event that Sandoz terminates the agreement for
convenience. The agreement between the two companies remains
in full force and effect, except as expressly covered in the
Amendment.
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. POSIMIR is a
drug candidate under development and has not been approved for
commercialization by the U.S. Food and Drug Administration (FDA) or
other health authorities.
About DURECT Corporation
DURECT is a biopharmaceutical company actively developing
therapeutics based on its Epigenetic Regulator Program and
proprietary drug delivery platforms. DUR‑928, a new chemical
entity in Phase 2 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, hepatic and renal diseases such as
nonalcoholic steatohepatitis (NASH) and Primary Sclerosing
Cholangitis (PSC), and inflammatory skin conditions such as
psoriasis and atopic dermatitis. DURECT's advanced oral and
injectable 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 3 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 which the FDA has set a PDUFA
(Prescription Drug User Fee Act) target action date of August 7, 2018. In addition, for the
assignment of certain patent rights, DURECT may receive a milestone
payment upon NDA approval and single digit sales-based earn-out
payments from U.S. net sales of Indivior's RBP-7000 investigational
drug for schizophrenia, for which Indivior has submitted an NDA and
for which the FDA has set a PDUFA target action date of
July 28, 2018. For more
information, please visit www.durect.com.
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 potential
milestone payments and royalties receivable from Sandoz, and the
potential use of DUR-928 to treat NASH, PSC, acute organ injury or
inflammatory skin diseases such as psoriasis 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 data for POSIMIR 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 and Sandoz's ability to obtain marketplace acceptance of
POSIMIR, the risk that the clinical trials of our other product
candidates will not be successful, our ability to 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 8, 2018 under the heading "Risk
Factors."
NOTE: POSIMIR®, SABER®, and
ORADUR® are trademarks of DURECT Corporation. Other
referenced trademarks belong to their respective owners.
DUR-928, RBP-7000, REMOXY ER and POSIMIR are drug candidates under
development and have not been approved for commercialization by the
U.S. Food and Drug Administration or other health authorities.
View original
content:http://www.prnewswire.com/news-releases/durect-announces-amendment-to-licensing-agreement-with-sandoz-related-to-posimir-saber-bupivacaine-300645154.html
SOURCE DURECT Corporation