CUPERTINO, Calif., Nov. 25,
2024 /PRNewswire/ -- DURECT Corporation (Nasdaq:
DRRX), a late-stage biopharmaceutical company pioneering the
development of epigenetic therapies to transform the treatment of
serious and life-threatening conditions such as acute organ injury,
today announced the sale of its ALZET® line of osmotic pumps
to Lafayette Instrument Co. (LIC), a portfolio company of Branford
Castle Partners II, L.P., a North-American focused private equity
firm.
Under the terms of the agreement, LIC
paid DURECT $17.5 million in exchange for certain assets
and liabilities associated with the ALZET product line.
Simultaneous with this transaction, DURECT has paid off all
remaining obligations under the term loan agreement with Oxford
Finance LLC.
"As DURECT continues to prioritize developing larsucosterol for
alcohol-associated hepatitis (AH), we have determined that the
ALZET product line is no longer aligned with our long-term
strategic priorities," said James E.
Brown, D.V.M., President and Chief Executive Officer of
DURECT. "This transaction strengthens our cash position and extends
our cash runway through the first half of 2025. With the payment of
the remainder of the Oxford term loan, we have greater financial
flexibility as we seek financial resources to fund our planned
Phase 3 clinical trial for larsucosterol in AH."
"ALZET osmotic pumps are a great addition to our life science
instruments. We look forward to continuing a shared legacy of
premier products that support life-changing research," said
Ben Mangrich, Chief Executive
Officer of Lafayette Instrument Company.
Aquilo Partners, L.P. acted as financial advisor and Wilson,
Sonsini, Goodrich & Rosati acted as legal advisor to
DURECT.
About ALZET
The ALZET product line consists of
miniature, implantable osmotic pumps and accessories for research
use in mice, rats and other laboratory animals. These pumps are
neither approved nor intended for human use. ALZET pumps
continuously deliver drugs, hormones and other test agents at
controlled rates from one day to six weeks without the need for
external connections, frequent handling or repeated dosing. In
laboratory research, these infusion pumps can be used for systemic
administration when implanted under the skin or in the body. They
can be attached to a catheter for intravenous, intracerebral, or
intra-arterial infusion or for targeted delivery, where the effects
of a drug or test agent are localized in a particular tissue or
organ. The wide use and applications of the ALZET product line is
evidenced by the more than 22,000 published scientific
references.
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. Larsucosterol, DURECT's lead drug candidate,
binds to and inhibits the activity of DNA methyltransferases,
epigenetic enzymes that are elevated and associated with
hypermethylation found in AH patients. Larsucosterol is in clinical
development for the potential treatment of AH, for which the FDA
has granted a Fast Track and a Breakthrough Therapy designation;
MASH 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. 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: our plans to conduct a
Phase 3 clinical trial of larsucosterol, the sufficiency of our
capital requirements through the first half of 2025 and the
potential uses of larsucosterol to treat patients with AH and
potentially other indications. 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 are delayed or 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 we do not raise sufficient capital to commence or complete the
Phase 3 clinical trial of larsucosterol in patients with AH or
continue to fund our operations, the risk that the FDA or other
government agencies may require additional clinical trials for
larsucosterol before approving larsucosterol for the treatment of
AH, the risk that Breakthrough Therapy designation does not
expedite the process for FDA approval and that larsucosterol may
never be approved; and risks related to the sufficiency of our cash
resources, our anticipated capital requirements, our ability to
continue to meet the minimum bid price for continued listing on
Nasdaq, 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 filings,
including its annual report on Form 10-K for the year ended
December 31, 2023 and quarterly
report on Form 10-Q for the quarter ended September 30, 2024, 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 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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SOURCE DURECT Corporation
