OCREVUS® subcutaneous (SC) injection
offers a new 10-minute administration with comparable efficacy and
safety to intravenous (IV) infusion
Provides an additional treatment option
without the need for IV facilities, expanding accessibility for
patients
SAN
DIEGO, June 25, 2024 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that
Roche received European Commission (EC) marketing authorization of
OCREVUS® (ocrelizumab) SC co-formulated with ENHANZE®, Halozyme's
proprietary recombinant human hyaluronidase enzyme, rHuPH20, for
the treatment of relapsing multiple sclerosis (RMS) and primary
progressive multiple sclerosis (PPMS).
OCREVUS® SC is a 10-minute injection that maintains the same
twice-yearly schedule as the approved IV infusion. The SC
injection was designed to be administered by healthcare
professionals, with the flexibility to be administered either in
the clinic or in settings outside the clinic.
"With OCREVUS SC, multiple sclerosis patients in the EU can now
have their medicine administered in just 10 minutes, twice per
year, and without the need for an IV facility," said Dr.
Helen Torley, president and chief
executive officer of Halozyme. "This creates enhanced flexibility
for both patients and providers and represents another example of
how Halozyme's breakthrough technologies help to create improved
treatment options."
The EC 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 IV formulation in patients with
RMS and PPMS. OCREVUS® SC was well tolerated, and no new safety
concerns were identified.
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
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 OCREVUS® SC.
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 Report on Form 10-Q filed with
the Securities and Exchange Commission. Except as required by law,
the Company 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.