Ocrelizumab

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 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 [email protected] Samantha Gaspar Teneo 212-886-9356 [email protected] SOURCE Halozyme Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

The FDA on Friday approved a new formulation of Roche and Genentech’s multiple sclerosis drug Ocrevus in what they hope will broadly expand access to the treatment. Patients will now be able to take Ocrevus through 10-minute subcutaneous injections rather than hours-long infusions. The drug, to be sold as Ocrevus Zunovo, will still be administered by physicians but won’t require long trips to specialized infusion centers, which the companies hope will make it easier for patients. Ocrevus Zunovo will be priced “at parity” with the infusion form’s annual wholesale acquisition cost, a Genentech spokesperson said. Ocrevus was priced at about $65,000 per year when it was first approved in 2017, but the cost has risen to roughly $80,000 annually. Regulators approved the new formulation based on data from the Phase 3 OCARINA II trial, which showed non-inferiority, and that twice-a-year injections of Ocrevus Zunovo suppressed MS relapse by 97% and reduced MRI lesions in the brain by 97.2% after 48 weeks. The trial enrolled patients with both relapsing and primary progressive MS, which IV Ocrevus is approved to treat. Ocrevus was Roche’s top-selling drug in 2023, pulling in about $7.5 billion in worldwide sales. In the first half of this year, its sales came in at just under $4 billion. The strategy follows the well-established model of IV infusion treatments eventually being updated with subcutaneous formulations. Generally, drugmakers try to develop infusion therapies first because it’s easier to get into the bloodstream, David Jones, the principal medical director of MS at Genentech, told Endpoints News . Access is very important to MS patients, Jones added. He said that when he used to be a practicing physician at the University of Virginia, some patients used to drive four to five hours for their infusion appointments. “Many infusion centers are fairly active, sometimes the wait times were long,” Jones said. “And sometimes, as you can imagine, for the western part of the state being Appalachia, taking a day off work was really challenging.” Editor’s note: This article has been updated to correct the brand name of subcutaneous Ocrevus. It is Ocrevus Zunovo, not Ocrevus Zyntulo.