Positive Results Announced from Phase 3 OCARINA II Trial Evaluating Roche's OCREVUS® (ocrelizumab) with Halozyme's ENHANZE® Drug Delivery Technology in Patients with Multiple Sclerosis

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Jul 13, 2023, 01:15 ET

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
[email protected]

Dawn Schottlandt
Argot Partners
212-600-1902
[email protected]

SOURCE Halozyme Therapeutics, Inc.