Updated Prescription Drug User Fee Act goal
date of December 29, 2024
SAN
DIEGO, May 21, 2024 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced
that Bristol Myers Squibb was reassigned a Prescription Drug User
Fee Act goal date from the U.S. Food and Drug Administration for
their Biologics License Application for the subcutaneous
formulation of Opdivo® (nivolumab) co-formulated
with ENHANZE®, Halozyme's proprietary recombinant human
hyaluronidase enzyme, rHuPH20, across all previously approved
adult, solid tumor Opdivo indications as monotherapy,
monotherapy maintenance following completion of Opdivo plus
Yervoy (ipilimumab) combination therapy, or in combination
with chemotherapy or cabozantinib. The updated goal date is
December 29, 2024.
The application is based on results from CheckMate-67T, the
first Phase 3 trial of the subcutaneous formulation of nivolumab
with ENHANZE® to evaluate and demonstrate
noninferior pharmacokinetics, efficacy and consistent safety vs.
its intravenous formulation. If approved, subcutaneous nivolumab
has the potential to be the first and only subcutaneously
administered PD-1 inhibitor.
About Halozyme
Halozyme is a biopharmaceutical company advancing disruptive
solutions to improve patient experiences and outcomes for emerging
and established therapies. As the innovators of ENHANZE®
drug delivery technology with the proprietary enzyme rHuPH20,
Halozyme's commercially-validated solution is used to facilitate
the subcutaneous delivery of injected drugs and fluids, with the
goal of reducing treatment burden for patients. Having touched more
than 800,000 patient lives in post-marketing use in seven
commercialized products across more than 100 global markets,
Halozyme has licensed its ENHANZE® technology to leading
pharmaceutical and biotechnology companies including Roche, Takeda,
Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx,
ViiV Healthcare, Chugai Pharmaceutical and Acumen
Pharmaceuticals.
Halozyme also develops, manufactures and commercializes, for
itself or with partners, drug-device combination products using its
advanced auto-injector technologies that are designed to provide
commercial or functional advantages such as improved convenience,
reliability and tolerability, and enhanced patient comfort and
adherence. The Company has two commercial proprietary products,
Hylenex® and XYOSTED®, partnered commercial
products and ongoing product development programs with several
pharmaceutical companies including Teva Pharmaceuticals and Idorsia
Pharmaceuticals.
Halozyme is headquartered in San
Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka is also the site of its operations
facility.
For more information visit www.halozyme.com and connect with us
on LinkedIn and Twitter.
Safe Harbor Statement
In addition to historical information, the statements set forth
above include forward-looking statements including, without
limitation, statements concerning the Prescription Drug User Fee
Act goal date for the Biologics License Application for the
subcutaneous formulation of Opdivo® (nivolumab)
co-formulated with ENHANZE®, possible activity, benefits
and attributes of ENHANZE®, the possible method of
action of ENHANZE®, its potential application to aid in
the dispersion and absorption of other injected therapeutic drugs,
and statements concerning certain other potential benefits of
ENHANZE® including facilitating more rapid delivery of
injectable medications through subcutaneous delivery and
potentially lowering the treatment burden for patients and
broadening the treatment options for the indication referred to in
this press release. These forward-looking statements also include
statements regarding the product development efforts of Halozyme's
ENHANZE® partners, potential additional data readouts,
indications and eligible patients for the ENHANZE®
co-formulated treatment referred to in this press release. These
forward-looking statements involve risks and uncertainties that
could cause actual results to differ materially from those in the
forward-looking statements. The forward-looking statements are
typically, but not always, identified through use of the words
"believe," "enable," "may," "will," "could," "intends," "estimate,"
"anticipate," "plan," "predict," "probable," "potential,"
"possible," "should," "continue," and other words of similar
meaning. Actual results could differ materially from the
expectations contained in forward-looking statements as a result of
several factors, including uncertainties concerning any potential
changes to the Prescription Drug User Fee Act goal date referred to
in this press release, whether new ENHANZE®
collaborative products, including Opdivo®
(nivolumab) co-formulated with ENHANZE®, are ultimately
developed, approved or commercialized or whether the indications
for the ENHANZE® co-formulated treatment referred to in
this press release will be approved, unexpected results or delays
in development and regulatory review, unexpected regulatory
approval requirements, unexpected adverse events or patient
outcomes from being treated with the ENHANZE®
co-formulated treatment referred to in this press release, and
competitive conditions. These and other factors that may result in
differences are discussed in greater detail in Halozyme's most
recent Annual and Quarterly Reports filed with the Securities and
Exchange Commission. Except as required by law, Halozyme undertakes
no duty to update forward-looking statements to reflect events
after the date of this release.
Contacts:
Tram Bui
VP, Investor Relations and Corporate Communications
609-359-3016
tbui@halozyme.com
Samantha Gaspar
Teneo
212-886-9356
samantha.gaspar@teneo.com
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SOURCE Halozyme Therapeutics, Inc.