- POSIMIR® is now commercially available in the U.S. for
the treatment of post-surgical pain in adults following
arthroscopic subacromial decompression surgery
- DURECT recently received an $8
million milestone payment for a new patent issuance and has
now earned a $2 million milestone
payment for first commercial sale of POSIMIR
ATHLONE, Ireland and CUPERTINO, Calif., Sept. 26,
2022 /PRNewswire/ -- Innocoll Pharmaceuticals
Limited, a commercial-stage biotechnology company and
portfolio business of Gurnet Point Capital, and DURECT Corporation
(Nasdaq: DRRX) today announced the recent commercial launch of
POSIMIR® (bupivacaine solution) in the United States. POSIMIR
is an FDA-approved non-opioid, sustained-release local analgesic
for the treatment of post-surgical pain in adults following
arthroscopic subacromial decompression surgery.
"We are excited to bring a potential cornerstone of multi-modal
post-operative pain management to surgeons with the launch of
POSIMIR," said Louis Pascarella,
Chief Executive Officer of Innocoll. "The launch of POSIMIR
establishes Innocoll as a leader in non-opioid pain management with
two commercialized bupivacaine-based, sustained-release, non-opioid
products and we look forward to bringing this new option to
patients."
"We are pleased that Innocoll, with its dedicated hospital sales
and marketing organization, has launched POSIMIR in the United States and recorded its first
sales," added James E. Brown,
President and Chief Executive Officer of DURECT Corporation.
"Bringing a new non-opioid analgesic option with POSIMIR is a
welcome next step in the evolution of pain management for
patients."
Per the terms of the collaboration between Innocoll and DURECT,
Innocoll will make a $2 million
payment to DURECT triggered by the first commercial sale of
POSIMIR. Previously, in August 2022,
DURECT was issued a new patent by the US Patent Office, extending
US patent coverage of POSIMIR to at least 2041, resulting in an
$8 million milestone payment by
Innocoll to DURECT. These payments are in addition to the
$4 million upfront license fee
received in January 2022. As the
launch progresses, DURECT will receive tiered, low double-digit to
mid-teen royalties on net product sales in the United States, as well as additional
milestone payments up to $122 million
in the aggregate, depending on the achievement of certain
commercial, regulatory and intellectual property milestone payments
with respect to POSIMIR.
In addition to the exclusive right to develop and commercialize
POSIMIR in the United States,
Innocoll also has been granted the right to conduct additional
development activities to expand the approved indications for
POSIMIR, and DURECT's contract manufacturing supply agreement for
POSIMIR has been assigned to Innocoll. DURECT retains all
commercial rights to POSIMIR throughout the rest of the world.
About POSIMIR
POSIMIR® (bupivacaine solution) for infiltration use is a novel
and proprietary product that combines the strength of 660 mg of
bupivacaine base with the innovative SABER® platform technology,
enabling continuous sustained delivery of a non-opioid local
analgesic over 3 days in adults. POSIMIR contains more bupivacaine
than any other approved single-dose sustained-release bupivacaine
product. At the end of surgery, POSIMIR is administered into
the subacromial space under direct arthroscopic visualization,
where it continuously releases bupivacaine for 72 hours or
more.
Indications and Usage
POSIMIR® (bupivacaine solution) for infiltration use is
indicated in adults for administration into the subacromial space
under direct arthroscopic visualization to produce post-surgical
analgesia for up to 72 hours following arthroscopic subacromial
decompression.
Limitations of Use
Safety and effectiveness have not been established in other
surgical procedures, including soft tissue surgical procedures,
other orthopedic procedures, including for intra-articular
administration, and boney procedures, or when used for neuraxial or
peripheral nerve blockade.
Full Prescribing Information, including the Boxed Warning, is
available at www.POSIMIR.com
Important Safety
Information
BOXED WARNING: Risk of Potential Adverse Embolic Effects
Resulting From Inadvertent Intravascaular Injection. Inadvertent
intravascular injection could cause POSIMIR droplets to be
deposited in the pulmonary and other capillary beds.
Administer POSIMIR into the subacromial space at the end of
arthroscopic shoulder surgery. Direct arthroscopic visualization
must be used to confirm proper placement of the needle tip before
injecting POSIMIR.
In POSIMIR clinical studies, no inadvertent intravascular
injections were observed. Do not inject POSIMIR
intravascularly.
POSIMIR is contraindicated in patients with a known
hypersensitivity to any amide local anesthetic, or other components
of POSIMIR, as well as in patients undergoing obstetrical
paracervical block anesthesia. There is a risk of joint cartilage
necrosis with unapproved intra-articular use of POSIMIR. Unintended
intravascular injection of POSIMIR may be associated with systemic
toxicities, including CNS or cardiorespiratory depression and coma,
progressing ultimately to respiratory arrest. As with other local
anesthetics, patients should be monitored for central nervous
system, cardiovascular, and allergic reactions. Avoid additional
use of local anesthetics within 168 hours following administration
of POSIMIR. Cases of methemoglobinemia have been reported in
association with use of local anesthetics. There have been reports
of chondrolysis (mostly in the shoulder joint) following
intra-articular infusion of local anesthetics, which is an
unapproved use. POSIMIR should be used cautiously in patients with
impaired hepatic and cardiovascular function. Adverse events
reported with an incidence greater than or equal to 10% and greater
than control following POSIMIR administration in shoulder surgery
were dizziness, dysgeusia, dysuria, headache, hypoesthesia,
paresthesia, tinnitus, and vomiting. Adverse events reported
with an incidence greater than or equal to 10% and greater than
control following POSIMIR administration in soft tissue surgical
procedures were anemia, bradycardia, constipation, C-reactive
protein increased, diarrhea, dizziness, dysgeusia, headache,
nausea, post-procedural contusion (bruising), procedural pain,
pruritus, pyrexia, somnolence, surgical site bleeding, visible
bruising and vomiting.
To report SUSPECTED ADVERSE REACTIONS, contact Innocoll at
1-833-606-1421 or FDA at 1–800–FDA-1088 or
www.fda.gov/medwatch.
About Innocoll
Innocoll Pharmaceuticals Limited is a global biotech
pharmaceutical company headquartered in Athlone, Ireland and is a subsidiary of Innocoll
Biotherapeutics Holding Limited. The Innocoll group of companies is
focused on the development and commercialization of pharmaceutical
technologies to meet some of today's most important healthcare
challenges.
Innocoll is a portfolio business of Gurnet Point
Capital.www.innocoll.com
About DURECT Corporation
DURECT is a biopharmaceutical company committed to transforming
the treatment of acute organ injury and chronic liver diseases by
advancing novel and potentially lifesaving therapies based on its
endogenous epigenetic regulator program. Larsucosterol (also known
as DUR-928), DURECT's lead drug candidate, binds to and inhibits
the activity of DNA methyltransferases (DNMTs), epigenetic enzymes
which are elevated and associated with hypermethylation found in
alcohol-associated hepatitis (AH) patients. Larsucosterol is in
clinical development for the potential treatment of AH, for which
FDA has granted a Fast Track Designation; non-alcoholic
steatohepatitis (NASH) is also being explored. In addition,
POSIMIR® (bupivacaine solution) for infiltration use, a non-opioid
analgesic utilizing the innovative SABER® platform technology, is
FDA-approved and has been exclusively licensed to Innocoll
Pharmaceuticals for development and commercialization in
the United States. For more
information about DURECT, please visit www.www.durect.com and
follow us on Twitter https://twitter.com/DURECTCorp.
DURECT Forward-Looking
Statement
This press release contains forward-looking statements,
including statements made pursuant to the safe harbor provisions of
the Private Securities Litigation Reform Act of 1995, relating to:
the commercial launch of POSIMIR by Innocoll and potential future
payments we may receive from Innocoll, the potential to develop
larsucosterol for AH, NASH or other indications, and the potential
benefits, if any, of our product candidates. Actual results may
differ materially from those contained in the forward-looking
statements contained in this press release, and reported results
should not be considered as an indication of future performance.
The potential risks and uncertainties that could cause actual
results to differ from those projected include, among other things,
the risk that Innocoll may not commercialize POSIMIR successfully,
the risk that the AHFIRM trial takes longer to conduct than
anticipated due to COVID-19 or other factors, the risk that ongoing
and future clinical trials of larsucosterol do not confirm the
results from earlier clinical or pre-clinical trials, or do not
demonstrate the safety or efficacy of larsucosterol in a
statistically significant manner, 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
most recent Securities and Exchange Commission (SEC) filings,
including its annual report on Form 10-K for the year ended
December 31, 2021 and quarterly
report on Form 10-Q for the quarter ended June 30, 2022 under the heading "Risk
Factors." These reports are available on our website
www.durect.com under the "Investors" tab and on the SEC's website
at www.sec.gov. All information provided in this press release and
in the attachments is based on information available to DURECT as
of the date hereof, and DURECT assumes no obligation to update this
information as a result of future events or developments, except as
required by law.
NOTE: POSIMIR® is a trademark of Innocoll Pharmaceuticals
Limited in the U.S. and a trademark of DURECT Corporation outside
of the U.S. SABER® is a trademark of DURECT Corporation. Other
referenced trademarks belong to their respective owners.
Larsucosterol (DUR-928) is an investigational drug candidate under
development and has not been approved for commercialization by the
U.S. Food and Drug Administration or other health authorities for
any indication.
SOURCE: Innocoll Pharmaceuticals Limited and DURECT
Corporation
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SOURCE DURECT Corporation