Four new targets nominated for total of six
nominated targets, including FcRn (VYVGART® Hytrulo),
for ENHANZE® drug delivery technology
Halozyme to receive total upfront payment of
$30 million for exclusive rights to
targets
SAN
DIEGO, Oct. 3, 2024 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) today announced that argenx has
nominated four new targets under its global collaboration and
license agreement that provides argenx exclusive access to
Halozyme's ENHANZE® drug delivery technology, a
proprietary recombinant human hyaluronidase PH20 enzyme (rHuPH20)
for rapid subcutaneous drug delivery. argenx, a global immunology
company, now has exclusively licensed ENHANZE® for a
total of six targets, including for the neonatal Fc receptor (FcRn)
target. VYVGART® Hytrulo, argenx's branded FcRn blocker,
is approved by the U.S. Food and Drug Administration for chronic
inflammatory demyelinating polyneuropathy and generalized
myasthenia gravis, with additional approvals granted in >25
countries globally for the latter indication.
Under the terms of the expanded exclusive agreement, argenx will
make upfront payments of $7.5 million
per target nomination for a total of $30
million to Halozyme, and potential future milestone payments
related to development progress, regulatory approvals, and sales
attainment of up to $85 million per
nominated target.
The royalty rate for all products under the agreement is a
tiered mid-single digit rate based on annual net sales until
expiration of Halozyme's ENHANZE® related patents, when
the rate will be reduced in one or more steps. Royalties will be
paid for the longer of 10 years from the first commercial sale or
until the expiration of the last valid claim of a co-formulation
patent.
"We are very pleased to strengthen our relationship with argenx,
an innovative leader in immunology dedicated to improving the lives
of people suffering from severe autoimmune diseases. We share
argenx's patient centric mission and are united in our commitment
to improve the lives of patients. As the leader in rapid
subcutaneous drug delivery, ENHANZE has clinically demonstrated
shorter administration time, offering patients and healthcare
practitioners with more convenience and flexibility in how
therapies are delivered," said Dr. Helen
Torley, president and chief executive officer. "With the
strong proven success of ENHANZE, we look forward to further
supporting argenx's momentum as they expand their immunology
pipeline with subcutaneous delivery of therapeutics to achieve
their Vision 2030."
Tim Van Hauwermeiren, Chief Executive Officer of argenx, added,
"We are very excited to have access to Halozyme's leading
subcutaneous delivery technology now for six different targets. The
expansion of our exclusive access to ENHANZE plays a critical role
in solidifying our leadership position and delivering on our
commitment to providing life-changing immunology solutions to
patients."
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 improving the patient experience with rapid subcutaneous
delivery and reduced treatment burden. Having touched more than
800,000 patient lives in post-marketing use in eight 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 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 and
administration of larger volumes of injectable medications through
subcutaneous delivery and potentially lowering the treatment burden
for patients. These forward-looking statements also include
statements regarding the product development and commercialization
efforts of Halozyme's ENHANZE® partner (including the
potential regulatory approval and launch of ENHANZE®
products as a result of such efforts and the potential future
market opportunity for such products) and Halozyme's potential
receipt of an upfront payment and payments associated with
achievement of certain development, regulatory and sales-based
milestones, and royalties on sales of commercialized
products. 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 whether development,
regulatory and sales-based milestones will be achieved,
uncertainties concerning whether collaborative products are
ultimately developed, approved or commercialized and the potential
future market for such products, unexpected expenditures and costs,
unexpected results or delays in development and regulatory review,
unexpected regulatory approval requirements, unexpected adverse
events or patient outcomes 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.
