FDA approval marks first and only subcutaneous
anti-PD-(L)1 cancer immunotherapy
SAN
DIEGO, Sept. 12, 2024 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that
Roche received U.S. Food and Drug Administration (FDA) approval for
Tecentriq Hybreza™ (atezolizumab and hyaluronidase-tqjs) with
Halozyme's ENHANZE® drug delivery technology. Tecentriq Hybreza™
can be injected subcutaneously in approximately 7 minutes compared
to 30-60 minutes for standard intravenous (IV) infusion of
Tecentriq® (atezolizumab). The treatment will be available in the
U.S. for all approved adult indications of intravenous Tecentriq®,
including certain types of lung, liver, skin and soft tissue
cancer.
Tecentriq Hybreza™ is a subcutaneous product combination of
atezolizumab, a monoclonal antibody that targets PD-(L)1 aiming to
prevent cancer immune evasion, and Halozyme's proprietary
recombinant human hyaluronidase enzyme, rHuPH20.
"We are delighted that Tecentriq Hybreza has been approved in
the U.S. for all approved adult indications of the IV treatment,"
said Dr. Helen Torley, president and
chief executive officer of Halozyme. "This approval represents
another opportunity for our ENHANZE technology to provide patients
and physicians with greater flexibility and a new option for how
treatment is administered."
The FDA approval is based on pivotal data from Roche's Phase
IB/III IMscin001 study, which showed comparable levels of
Tecentriq® in the blood when administered subcutaneously, and a
safety and efficacy profile consistent with the IV formulation.
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 of injectable medications through
subcutaneous delivery and potentially lowering the treatment burden
for patients and broadening the treatment options for the
indications 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 whether new
ENHANZE® collaborative products are ultimately developed, approved
or commercialized, unexpected results or delays in launch or
commercialization of our partner's product referred to in this
press release, 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.
Tecentriq® (atezolizumab) is a registered trademark of
Genentech, a member of the Roche Group.
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
View original content to download
multimedia:https://www.prnewswire.com/news-releases/halozyme-announces-fda-approval-of-roches-tecentriq-hybreza-with-enhanze-for-multiple-types-of-cancer-302247280.html
SOURCE Halozyme Therapeutics, Inc.