CUPERTINO, Calif., Oct. 2, 2017 /PRNewswire/ -- DURECT
Corporation (Nasdaq: DRRX) today announced a patent purchase
agreement with Indivior UK Limited, an affiliate of Indivior PLC
(LON: INDV), whereby DURECT has assigned certain of its U.S. patent
rights to Indivior. This assignment may provide further
intellectual property protection for RBP-7000, Indivior's
investigational once-monthly injectable risperidone product for the
treatment of schizophrenia. Indivior today announced that it
has submitted a New Drug Application (NDA) for RBP-7000 to the U.S.
Food and Drug Administration (FDA).
Under the terms of the agreement, Indivior has made an upfront
non-refundable payment to DURECT of $12.5
million, with the potential for an additional $5 million based on a regulatory milestone, 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 patent rights, including RBP-7000. The patent rights include
granted patents extending through at least 2026.
"It is rewarding to know that Indivior's RBP-7000, if approved,
has the potential to help patients with schizophrenia and that our
shareholders will have the opportunity to participate in potential
future revenues from this product," said James E. Brown, President and CEO of DURECT
Corporation.
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 the Company'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 1000 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 be accepted for review by the FDA or 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 August 9, 2017 under the heading "Risk
Factors."
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SOURCE DURECT Corporation