Halozyme Announces OCREVUS® SC with ENHANZE® from Roche Receives European Commission Approval for the Treatment of Relapsing and Primary Progressive Multiple Sclerosis

OCREVUS® Subcutaneous (SC) injection provides repeat administration within 10 minutes with efficacy and safety comparable 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 has received marketing authorization from the European Commission (EC) for OCREVUS® (ocrelizumab) SC co-formulated with ENHANZE®, Halozyme’s exclusive human recombinant product. 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 follows the same biannual schedule as the approved IV infusion. The SC injection has been designed to be administered by healthcare professionals, with the option of being administered either in-clinic or out-of-clinic.

“Thanks to OCREVUS SC, multiple sclerosis patients in the EU can now have their medications administered in just 10 minutes, twice a year, and without the need for an intravenous setup,” said Dr. Helene Torley, President and CEO of Halozyme. “This creates increased flexibility for both patients and providers and represents another example of how Halozyme’s revolutionary technologies are helping 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 that of the IV formulation in patients with RMS and PPMS. . OCREVUS® SC was well tolerated and no new safety issues were identified.

About Halozyme

Halozyme is a biopharmaceutical company that delivers breakthrough solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovator of ENHANZE® drug delivery technology with the proprietary rHuPH20 enzyme, Halozyme’s commercially validated solution is used to facilitate subcutaneous delivery of injected medications and fluids, with the goal of reducing the burden of treatment on patients. Having touched the lives of more than 800,000 patients after commercializing seven products in over 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.

The story continues

Halozyme also develops, manufactures and markets, for itself or with partners, drug-device combination products utilizing its advanced auto-injector technologies that are designed to provide commercial or functional benefits such as convenience, reliability and tolerability, as well as improved patient comfort and compliance. . The Company has two proprietary commercial 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, California and has offices in Ewing, New Jersey And Minnetonka, Minn. Minnesota is also the site of its operational 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 regarding 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 facilitate the dispersion and absorption of other injected therapeutic drugs, facilitating more rapid delivery and administration of higher volumes of injectable drugs by subcutaneous administration and some other benefits of ENHANZE®, including reduced treatment burden for patients and pressure relief. on health system resources, including the potential administration of OCREVUS® SC outside of the hospital. 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 generally, but not always, identified by the use of the words “believe”, “allow”, “may”, “will”, “could”, “intend”, “estimate”, ” anticipate”, “plan”, “predict”, “likely”, “potential”, “possible”, “should”, “continue” and other words of similar meaning and involving risks and uncertainties that could affect so that actual results will differ materially from those in the forward-looking statements. Actual results could differ materially from 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 products in progress. partnership, regulatory approval requirements, unexpected adverse events or patient outcomes and competitive conditions. These and other factors that could cause differences are discussed more fully 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. Exchange Commission. Except as required by law, the Company undertakes no obligation to update any forward-looking statements to reflect events after the date of this release.

Contacts:
Tram Bui
Vice President, Investor Relations and Corporate Communications
609-359-3016
[email protected]

Samantha Gaspar
Teneo
212-886-9356
[email protected]

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SOURCE Halozyme Therapeutics, Inc.