SAN
DIEGO, July 13, 2023 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that
Roche's Phase 3 OCARINA II trial evaluating OCREVUS®
(ocrelizumab) with ENHANZE® as a twice a
year 10-minute subcutaneous (SC) injection, met its primary
and secondary endpoints in patients with relapsing forms of
multiple sclerosis (MS) or primary progressive MS (RMS or
PPMS).
OCREVUS subcutaneous injection co-formulated with
ENHANZE®, Halozyme's proprietary recombinant
human hyaluronidase enzyme, rHuPH20, was shown to be non-inferior
to OCREVUS given by intravenous infusion (IV) as measured by
pharmacokinetics (levels in the blood) at 12 weeks. OCREVUS
subcutaneous injection also was comparable to OCREVUS IV in
controlling magnetic resonance imaging (MRI) lesion activity in the
brain over 12 weeks. The safety profile of OCREVUS subcutaneous
injection was consistent with that of OCREVUS IV.
"We are delighted that these positive Phase 3 data for OCREVUS
administered subcutaneously with ENHANZE opens up the potential for
people living with multiple sclerosis to receive their treatment in
just 10 minutes, twice a year," said Dr. Helen Torley, president and chief executive
officer of Halozyme. "Regulatory Authority approval of subcutaneous
administration of OCREVUS with ENHANZE would create the possibility
to administer OCREVUS in additional MS centers without IV
infrastructure or with IV capacity constraints."
The subcutaneous formulation of OCREVUS with ENHANZE®
retains the twice-yearly dosing regimen of OCREVUS IV that has
shown high persistence and adherence since becoming a standard of
care MS treatment, potentially providing an additional delivery
option for patients and healthcare professionals.
Roche will share detailed results from the OCARINA II trial at
an upcoming medical meeting and submit the data for regulatory
approval to health authorities
globally.
About the OCARINA II study
OCARINA II is a global Phase III multicentre, randomised study
evaluating the pharmacokinetics, safety and radiological and
clinical effects of the subcutaneous formulation of OCREVUS
compared with OCREVUS IV in 236 patients with RMS or PPMS. The
primary endpoint is non-inferiority in a serum model-predicted area
under the curve (AUC) from day 1 to 12 weeks after subcutaneous
injection compared to IV infusion. Secondary endpoints include
maximum serum concentration (Cmax) of OCREVUS, the total number of
active, gadolinium-enhancing T1 lesions at 8 and 12 weeks, and new
or enlarging T2 lesions at 12 and 24 weeks, as well as safety,
immunogenicity and biomarker outcomes. Exploratory endpoints
include patient-reported outcomes.
About Halozyme Therapeutics, Inc.
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 700,000
patient lives in post-marketing use in six 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 and Chugai Pharmaceutical.
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 XYOSTED®, TLANDO® and
NOCDURNA® and partnered commercial products and ongoing
product development programs with several pharmaceutical companies
including Teva Pharmaceutical, Pfizer 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, potentially
lowering the treatment burden for patients and broadening the
treatment options for the indication referred to in this press
release. These forward-looking statements also include statements
regarding the product development efforts of Halozyme's
ENHANZE® partner, including submitting clinical trial
data for regulatory approval to global health authorities. 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 the
ENHANZE® product referred to in this press release is ultimately
developed, approved or commercialized, unexpected results or delays
in development and regulatory review, unexpected regulatory
approval requirements, 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.
Contacts
Tram Bui
VP, Investor Relations and Corporate Communications
609-359-3016
tbui@halozyme.com
Dawn Schottlandt
Argot Partners
212-600-1902
Halozyme@argotpartners.com
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SOURCE Halozyme Therapeutics, Inc.