- Partnership agreement will be the first-ever co-marketing
and sales collaboration for the ALZET Osmotic Pumps Portfolio and
Associated Product Line in the U.S. and Canada
- Both companies will jointly market and commercialize the
ALZET product line to customers over a multi-year period
CUPERTINO, Calif. ,
March 4,
2024 /PRNewswire/ -- DURECT Corporation (Nasdaq:
DRRX), today announced that it has entered into a co-marketing and
collaboration agreement with Charles River Laboratories for the
ALZET® Osmotic Pumps Portfolio and Associated Product Line in the
U.S. and Canada. Charles River is a highly respected, global
provider of drug discovery and non-clinical development
solutions.
Charles River Research Models & Services (RMS) sales and
marketing teams will collaborate with DURECT to jointly market and
commercialize the ALZET product line to existing and new customers
in the pharmaceutical industry and academic laboratories over a
multi-year period. Charles River RMS will provide dedicated
marketing resources and collaborate with DURECT to develop and roll
out a broad range of sales and marketing initiatives for ALZET.
DURECT will remain responsible for manufacturing, marketing
support, order fulfillment and customer billing.
"The DURECT and Charles River RMS teams are excited by this
synergistic commercial partnership," said James E. Brown,
D.V.M., President and CEO of DURECT. "Both teams look forward
to collaborating to broaden awareness, promote and expand ALZET
sales across the U.S. and Canada."
About ALZET Osmotic Pumps
The ALZET product line consists of miniature implantable pumps
and a range of accessories for experimental research in mice, rats,
and other laboratory animals. ALZET pumps continuously deliver
drugs, hormones, and other test agents at controlled rates for
durations ranging from 1 day to 6 weeks. They eliminate the need
for external connections, frequent handling, or repeated dosing.
The wide use and broad application of the ALZET product line is
evidenced by more than 22,000 references in the scientific
literature. ALZET pumps are neither approved nor intended for human
use. For more information about the ALZET product line, please
visit https://www.alzet.com/.
About DURECT Corporation
DURECT is a late-stage biopharmaceutical company pioneering the
development of epigenetic therapies that target dysregulated DNA
methylation to transform the treatment of serious and
life-threatening conditions, including acute organ injury and
cancer. Larsucosterol, DURECT's lead drug candidate, binds to and
inhibits the activity of DNA methyltransferases (DNMTs), epigenetic
enzymes that 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. In addition,
POSIMIR® (bupivacaine solution) for infiltration use, a
non-opioid analgesic utilizing the innovative SABER® platform
technology, is FDA-approved and is exclusively licensed to Innocoll
Pharmaceuticals for sale and distribution in the United States. For more information about
DURECT, please visit www.durect.com and follow us on X
(formerly Twitter) at https://x.com/DURECTCorp.
DURECT Forward-Looking Statements
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 potential for larsucosterol to demonstrate a reduction in
mortality or liver transplant in patients with AH and to save
lives, our plans to meet with the FDA to review the results of
AHFIRM trial and the Phase 3 registration trial design in the first
quarter of 2024, the potential FDA or other regulatory approval of
larsucosterol for the treatment of AH, the commercialization of
POSIMIR by 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 future
clinical trials of larsucosterol do not confirm the results from
subset analyses of the AHFIRM trial, including geographic or other
segmentation, or of earlier clinical or pre-clinical trials, or do
not demonstrate the safety or efficacy of larsucosterol in a
statistically significant manner, the risk that the FDA or other
government agencies may require additional clinical trials for
larsucosterol before approving it for the treatment of AH, risks
that Innocoll may not commercialize POSIMIR successfully, and risks
related to the sufficiency of our cash resources, our anticipated
capital requirements, our need or desire for additional financing,
our ability to meet the minimum bid price for continued listing on
Nasdaq, our ability to obtain capital to fund our operations and
expenses and our ability to continue to operate as a going concern.
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, 2022 and quarterly
report on Form 10-Q for the quarter ended September 30, 2023, when filed, 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, 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 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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