CUPERTINO, Calif. and ATHLONE,
Ireland, Dec. 22, 2021 /PRNewswire/ -- DURECT Corporation
(Nasdaq: DRRX) today announced a licensing agreement granting
Innocoll Biotherapeutics plc, a specialty pharmaceutical company
and portfolio business of Gurnet Point Capital, exclusive
development and commercialization rights to POSIMIR® (bupivacaine
solution) for infiltration use, DURECT's FDA-approved non-opioid,
sustained-release local analgesic for the treatment of
post-surgical pain in adults following arthroscopic subacromial
decompression surgery, in the United
States.
"We are excited to license the U.S. development and
commercialization rights for POSIMIR to Innocoll, whose dedicated
hospital sales and marketing organization is deeply committed to
providing non-opioid analgesia products to patients in the
post-surgical setting," said James E. Brown, President and
Chief Executive Officer of DURECT Corporation. "Completing this
POSIMIR deal is another important step in the continued
transformation of DURECT as we continue to focus on larsucosterol,
our lead epigenetic regulator, which is in late-stage clinical
development for alcohol-associated hepatitis."
"We believe that POSIMIR has the potential to become a
cornerstone of multi-modal post-operative pain management as well
as an important contributor to the on-going efforts to provide safe
and effective alternatives to opioid-based medications following
surgery," added Louis Pascarella,
Chief Executive Officer of Innocoll. "Innocoll is now the only
company with two bupivacaine-based, sustained-release, non-opioid
products, that are FDA approved and indicated for relief of
post-surgical pain in specified surgical procedures. We are
currently on track to launch POSIMIR in the second quarter of 2022,
subject to commercial supply timelines."
Terms of the Collaboration
Under the terms of the agreement, Innocoll will make near-term
payments to DURECT of $6 million, consisting of a $4 million license fee and a $2 million payment upon first commercial sale,
with the potential for up to an additional $130
million in commercial, regulatory and intellectual property
milestone payments as well as tiered, low to mid double-digit
royalties on net product sales in the United States.
Innocoll has been granted the exclusive right to develop and
commercialize POSIMIR in the United States. Innocoll has also
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.
Conference Call
DURECT will host a conference call today to discuss the license
agreement with Innocoll:
Wednesday, December 22 @
8:30 a.m. Eastern Time
/ 5:30 a.m. Pacific
Time
Toll Free:
|
877-869-8261
|
International:
|
201-689-8261
|
Conference ID:
|
13725862
|
Webcast:
|
https://themediaframe.com/mediaframe/webcast.html?webcastid=86LaZ3eE
|
The conference call will also be available by webcast on
DURECT's homepage at www.durect.com under the "Investors"
tab. If you are unable to participate during the webcast, the
call will be archived on DURECT's website under "Event Calendar" in
the "Investors" section.
About Innocoll
Innocoll Biotherapeutics plc is a global specialty
pharmaceutical company headquartered in Athlone, Ireland. Innocoll Biotherapeutics plc and its
subsidiaries Innocoll Holdings Limited and Innocoll Pharmaceuticals
Limited, are focused on the development and commercialization of
pharmaceutical technologies to meet some of today's most important
healthcare challenges. Innocoll Biotherapeutics plc is a portfolio
business of Gurnet Point Capital. www.innocoll.com
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, oropharyngeal pain, post-procedural contusion (bruising),
procedural pain, pruritus, pyrexia, somnolence, surgical site
bleeding, visible bruising and vomiting.
To report SUSPECTED ADVERSE REACTIONS, contact DURECT
Corporation at 1-844-767-4647 or FDA at 1‑800‑FDA-1088 or
www.fda.gov/medwatch.
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. Full
prescribing information about POSIMIR, including the Boxed Warning,
can be found at www.posimir.com. For more information
about DURECT, please visit www.durect.com and follow
us on Twitter https://twitter.com/DURECTCorp.
DURECT Forward-Looking Statement. This press
release contains forward-looking statements relating to, among
other things, DURECT's relationship with Innocoll; milestone and
royalty payments that may be potentially paid to DURECT under the
license agreement with Innocoll, Innocoll's ability to achieve
regulatory and commercial milestones or DURECT's ability to achieve
intellectual property milestones, in each case, under the license
agreement with DURECT; statements about the potential launch of
POSIMIR in the second quarter of 2022, statements about the use of
POSIMIR to treat post-operative pain, statements about POSIMIR's
potential as an alternative to opioid-based medications following
surgery, the commercial potential of POSIMIR, statements about the
potential for larsucosterol (also known as DUR-928) to treat
patients with AH, NASH, multiple acute organ injury, chronic liver
diseases and other diseases, ongoing clinical trials of
larsucosterol, and the potential benefits of Fast Track
Designation. Any statements contained in this press release that
are not statements of historical fact may be deemed to be
forward-looking statements. Words such as "planned," "will," "may,"
"expect," "anticipate," and similar expressions are intended to
identify these forward-looking statements. These forward-looking
statements are based on DURECT's current expectations and
inherently involve significant risks and uncertainties. Actual
results and the timing of events could differ materially from those
anticipated in such forward looking statements as a result of these
risks and uncertainties, which include, without limitation, risks
and uncertainties that Innocoll may not launch POSIMIR as planned
or commercialize POSIMIR successfully, if at all; Innocoll's
ability to obtain supplies of POSIMIR; marketplace acceptance of
POSIMIR; the risk that Innocoll may terminate the license agreement
under conditions specified in the license agreement; the risk that
the clinical trial of larsucosterol in AH takes longer to conduct
than anticipated due to COVID-19 or other factors; the risk that
clinical trials of larsucosterol, including AHFIRM, do not confirm
the results from earlier clinical or pre-clinical trials, or do not
demonstrate the safety or efficacy or the lifesaving potential of
larsucosterol in a statistically significant manner; the risk that
Fast Track Designation for larsucosterol in AH may not lead to
faster FDA review or an approval; risks related to DURECT's ability
to obtain capital to fund operations and expenses; risks related to
market competition, and other risks described in the "Risk Factors"
section of DURECT's Quarterly Report on Form 10-Q for the period
ended September 30, 2021 filed with
the Securities and Exchange Commission (the "SEC") on November 3, 2021, and in other filings filed from
time to time with the SEC. DURECT does not undertake any obligation
to update forward-looking statements and expressly disclaims any
obligation or undertaking to release publicly any updates or
revisions to any forward-looking statements contained herein,
except as required by law.
NOTE: POSIMIR® is a trademark of Innocoll Pharmaceuticals, Ltd.
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.
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SOURCE DURECT Corporation