CUPERTINO, Calif., Dec. 19, 2018 /PRNewswire/ -- DURECT
Corporation (Nasdaq: DRRX) today announced that Indivior PLC
(LON: INDV) stated on December 18,
2018 that it is moving ahead with the launch of PERSERIS™ in
the U.S. with a sales force consisting of approximately 50
representatives. While PERSERIS™ has been available in the U.S.
since November 19, 2018, Indivior
stated that the commercial launch is scheduled to take place in
February 2019. Indivior stated that
its PERSERIS™ team is currently engaged in creating payor access,
growing prescriber awareness and interest, as well as establishing
its INSUPPORT™ patient hub. Indivior reiterated its
confidence in its peak net revenue goal for PERSERIS™ of
$200 to $300
million.
"We are pleased to see that Indivior is engaged in pre-launch
activities, and we look forward to the commercialization of
PERSERIS and the associated quarterly earn-out payments that we
will receive in the coming years," said James E. Brown,
President and CEO of DURECT.
On September 26, 2017, DURECT entered into a
patent purchase agreement whereby DURECT assigned
to Indivior UK Limited, an affiliate of Indivior PLC,
certain patents that may provide further intellectual property
protection for PERSERIS. In consideration for such
assignment, Indivior made an upfront non-refundable
payment to DURECT of $12.5
million. Indivior made an additional $5
million payment to DURECT in August 2018 following NDA approval of PERSERIS in
July 2018. DURECT is also entitled to
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 PERSERIS. The patent rights
include granted patents extending through at least 2026.
For additional information related to PERSERIS, please see the
disclosures made by Indivior or visit www.perserishcp.com.
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 such as Alcoholic Hepatitis (AH), 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. Late stage product candidates in this category include
POSIMIR® (bupivacaine extended release solution),
an investigational locally-acting, non-opioid analgesic intended to
provide up to 3 days of continuous pain relief after surgery, and
ORADUR®-Methylphenidate ER Capsules, approved
in Taiwan as Methydur Sustained Release Capsules, where
it is indicated for the treatment of attention deficit
hyperactivity disorder (ADHD). In addition, for the
assignment of certain patent rights related to its drug delivery
technology, DURECT will receive single digit sales-based
earn-out payments from U.S. net sales
of PERSERIS™ (risperidone), which was approved
by FDA in July 2018 for the treatment
of schizophrenia in adults and is owned and marketed by Indivior
PLC. For more information, please
visit www.durect.com.
NOTE: ORADUR®, POSIMIR® and
SABER® are trademarks of DURECT
Corporation. Other referenced trademarks belong to their respective
owners. DUR-928 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.
DURECT Forward-Looking Statement
The statements in
this press release regarding the potential commercial sale of
Indivior's PERSERIS to treat schizophrenia, including the timing of
U.S. launch, size of U.S. sales force, potential peak net revenue
and earn-out payments receivable from Indivior, as well as the
potential use of POSIMIR to treat post-surgical pain, and the
potential use of DUR-928 to treat Alcoholic Hepatitis, hepatic and
renal diseases such as nonalcoholic steatohepatitis (NASH) and
Primary Sclerosing Cholangitis (PSC), and inflammatory skin
conditions such as psoriasis and atopic dermatitis 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 Indivior will not
launch PERSERIS commercially or that it will not obtain market
acceptance and meaningful sales, as well as possible adverse events
associated with the use of PERSERIS, POSIMIR 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 and DUR-928, and the possibility that studies of DUR-928
will not replicate results from earlier preclinical or clinical
trials. Further information regarding risks related to
DUR-928 and POSIMIR and other risks related to DURECT is included
in DURECT's Form 10-Q filed on November 8,
2018 under the heading "Risk Factors."
View original
content:http://www.prnewswire.com/news-releases/commercial-launch-plans-announced-for-perseris-risperidone-extended-release-injectable-suspension-for-the-treatment-of-schizophrenia-in-adults-300768672.html
SOURCE DURECT Corporation