CUPERTINO, Calif., Dec. 13, 2017 /PRNewswire/ -- DURECT
Corporation (Nasdaq: DRRX) today announced that Indivior PLC (LON:
INDV) has reported that the U.S. Food and Drug Administration (FDA)
has accepted the New Drug Application (NDA) for RBP-7000.
RBP-7000 is an investigational, once-monthly injectable risperidone
for the treatment of schizophrenia. Indivior PLC further reported
that the FDA has set a PDUFA (Prescription Drug User Fee Act)
target action date of July 28,
2018.
On September 26, 2017, DURECT
entered into a patent purchase agreement whereby DURECT has
assigned to Indivior UK Limited, an affiliate of Invidior PLC,
certain patents that may provide further intellectual property
protection for RBP-7000. In consideration for such assignment,
Indivior has made an upfront non-refundable payment to DURECT of
$12.5 million, and has also agreed to
make an additional $5 million payment
to DURECT contingent upon NDA approval of RBP-7000, as well as
quarterly earn-out payments that are based on a single digit
percentage of U.S. net sales for certain products covered by the
assigned patent rights, including RBP-7000. The patent rights
include granted patents extending through at least 2026.
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, chronic metabolic diseases such as
nonalcoholic fatty liver disease (NAFLD), nonalcoholic
steatohepatitis (NASH) and other liver diseases with both broad and
orphan populations, and inflammatory skin conditions such as
psoriasis. 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 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 more information, please
visit www.durect.com.
About Indivior
Indivior is a global specialty pharmaceutical company with a
20-year legacy of leadership in patient advocacy and health policy
while providing education on evidence-based treatment models that
have revolutionized modern addiction treatment. The name is the
fusion of the words individual and endeavour, and the tagline
"Focus on you" makes Invidior's commitment clear. Indivior is
dedicated to transforming addiction from a global human crisis to a
recognized and treated chronic disease. Building on its global
portfolio of opioid dependence treatments, Indivior has a strong
pipeline of product candidates designed to both expand on its
heritage in this category and address other chronic conditions and
co-occurring disorders of addiction, including alcohol use disorder
and schizophrenia. Headquartered in the
United States in Richmond,
VA, Indivior employs more than 900 individuals globally and
its portfolio of products is available in over 40 countries
worldwide. Visit www.indivior.com to learn more.
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 drug candidates, including the potential use
of Indivior's RBP-7000 to treat schizophrenia, and the potential
milestone payment and earn-out payments receivable from Indivior,
as well as the potential use of POSIMIR to treat post-surgical
pain, the potential use of REMOXY ER to treat pain, and the
potential use of DUR-928 to treat NASH, other liver diseases, acute
organ injury or inflammatory skin conditions 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 that the NDA submission
of RBP-7000 will not result in product approval, as well as
possible adverse events associated with the use of POSIMIR, REMOXY
ER and DUR-928, delays and costs due to additional work or other
requirements imposed by regulatory agencies for continued
development, approval or sale of POSIMIR, REMOXY ER and DUR-928,
and the possibility that studies of POSIMIR, REMOXY ER and DUR-928
will not replicate results from earlier clinical trials.
Further information regarding risks related to POSIMIR, REMOXY ER
and DUR-928 and other risks related to DURECT is included in
DURECT's Form 10-Q filed on November 2,
2017 under the heading "Risk Factors."
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SOURCE DURECT Corporation