OCREVUS ZUNOVO™ has the potential to expand
treatment options to centers without IV infrastructure or with IV
constraints
SAN
DIEGO, Sept. 13, 2024 /PRNewswire/
-- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today
announced that Roche received U.S. Food and Drug Administration
(FDA) approval for OCREVUS ZUNOVO™ (ocrelizumab and
hyaluronidase-ocsq) with Halozyme's ENHANZE® drug delivery
technology for the treatment of relapsing multiple sclerosis (RMS)
and primary progressive multiple sclerosis (PPMS) as a
twice-a-year, approximately 10-minute subcutaneous (SC)
injection to be administered by a healthcare practitioner.
"We are pleased that the subcutaneous formulation of OCREVUS,
OCREVUS ZUNOVO, which contains our ENHANZE drug delivery
technology, is now approved in the U.S. for patients with these two
forms of multiple sclerosis," said Dr. Helen Torley, president and chief executive
officer of Halozyme. "OCREVUS ZUNOVO offers greater treatment
flexibility and optionality for patients with multiple sclerosis
and their healthcare providers."
The FDA approval is based on pivotal data from the Phase III
OCARINA II trial, which showed non-inferior levels of OCREVUS in
the blood when administered subcutaneously, and a safety and
efficacy profile comparable to the intravenous (IV) formulation in
people with RMS and PPMS. The most common adverse events with
OCREVUS ZUNOVO were injection reactions, all of which were either
mild or moderate, and none of which led to treatment withdrawal.
Out of the exploratory outcomes measured, OCREVUS ZUNOVO was
consistent with IV, demonstrating suppression of relapse activity
(97%) and MRI lesions (97%) through 48 weeks. Additionally, there
were patient-reported outcomes measured during the study, that
showed more than 92% of trial participants reported being satisfied
or very satisfied with the SC administration of OCREVUS ZUNOVO.
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 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.
OCREVUS ZUNOVO™ is a 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
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SOURCE Halozyme Therapeutics, Inc.