SAN
DIEGO, Jan. 29, 2024 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that
Takeda received European Commission (EC) approval for
HYQVIA® [Immune Globulin Infusion 10% (Human)]
co-formulated with Halozyme's ENHANZE® drug delivery
technology as maintenance therapy in patients of all ages with
chronic inflammatory demyelinating polyneuropathy (CIDP) after
stabilization with intravenous immunoglobulin therapy (IVIG).
HYQVIA® also recently received U.S. Food and Drug
Administration (FDA) approval as maintenance therapy for adults
with CIDP.
HYQVIA® is the only FDA and now EC-approved
combination of immunoglobulin (IG) and hyaluronidase for CIDP and
is administered by facilitated subcutaneous infusion. For patients
with CIDP, HYQVIA® can be infused up to once monthly
(every two, three or four weeks). HYQVIA® can be
administered by a healthcare professional or self-administered in
the patient's home after appropriate training.
"The demand for new personalized maintenance treatment options
for patients with CIDP continues to grow, and we are pleased to
partner with Takeda to expand the HYQVIA offering to Europe," said Dr. Helen Torley, president and chief executive
officer of Halozyme.
The centralized marketing authorization for HYQVIA®
in CIDP is valid in all EU member states as well as in Iceland, Liechtenstein, Norway and Northern
Ireland.
About Halozyme
Halozyme is a biopharmaceutical company bringing disruptive
solutions to significantly improve patient experiences and outcomes
for emerging and established therapies. As the innovators of the
ENHANZE® technology with the proprietary enzyme rHuPH20,
Halozyme's commercially-validated solution is used to facilitate
the delivery of injected drugs and fluids in order to reduce the
treatment burden to 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, AbbVie,
Eli Lilly, Bristol Myers Squibb, Alexion, argenx, Horizon
Therapeutics, 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 technology that are designed to provide
commercial or functional advantages such as improved convenience
and tolerability, and enhanced patient comfort and adherence. The
Company has a commercial portfolio of proprietary products
including Hylenex® and XYOSTED® and 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
in this press release include forward-looking statements including,
without limitation, statements concerning the Company's
ENHANZE® drug delivery technology including the possible
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,
facilitating more rapid delivery and administration of higher
volumes of injectable medications through subcutaneous delivery and
certain other benefits of ENHANZE® including lowering
the treatment burden for patients and alleviating pressure on
health care system resources, including potential out-of-hospital
administration of HYQVIA® . Forward-looking statements
regarding the Company's ENHANZE® business may include
potential growth driven by our partners' development and
commercialization efforts (including anticipated regulatory
submissions, PDUFA dates, potential regulatory approvals,
indications and product launches). These 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 and involve risk and uncertainties that could cause actual
results to differ materially from those in the forward-looking
statements. Actual results could differ materially from the
expectations contained in these forward-looking statements as a
result of several factors, including unexpected results or delays
in the growth of the Company's business, or in the development,
regulatory review or commercialization of the Company's partnered
products, 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 the Company's most recent Annual Report on Form
10-K and Quarterly Reports on Form 10-Q filed with the Securities
and Exchange Commission.
Contacts:
Tram Bui
VP, Investor Relations and Corporate Communications
609-359-3016
tbui@halozyme.com
Samantha Gaspar
Teneo
617-877-9710
samantha.gaspar@teneo.com
References:
European Medicines Agency. HyQvia product information.
HYQVIA® [Immune Globulin Infusion 10% (Human) with
Recombinant Human Hyaluronidase] U.S. Prescribing Information.
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SOURCE Halozyme Therapeutics, Inc.