Hyaluronidase Recombinant Human

European Commission (EC) decision on marketing authorization application expected within approximately two months SAN DIEGO, April 28, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that argenx received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommending European Commission (EC) approval of VYVGART® 1000mg (efgartigimod alfa) developed with ENHANZE®, Halozyme's proprietary recombinant human hyaluronidase enzyme (rHuPH20) for subcutaneous (SC) injection as a monotherapy for the treatment of adult patients with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP) after prior treatment with corticosteroids or immunoglobulins. The SC injection of VYVGART® is available as a vial or prefilled syringe and can be administered by a patient, caregiver, or healthcare professional. VYVGART is the first and only targeted IgG Fc-antibody fragment for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and the first novel mechanism of action for CIDP treatment in more than 30 years. "We are delighted that the subcutaneous injection of VYVGART® co-formulated with our ENHANZE drug delivery technology, has been recommended for approval in the European Union. The positive CHMP opinion moves argenx closer to offering patients throughout Europe a groundbreaking new treatment option. We are proud to support argenx achieve their vision of developing innovative, targeted treatments for patients with rare and severe autoimmune diseases," said Dr. Helen Torley, president and chief executive officer of Halozyme. The CHMP recommendation is based on positive results from the ADHERE clinical trial, the largest study of CIDP patients to date. For more information on the CHMP recommendation, and the ADHERE study and its findings, please view argenx's press release issued on April 28, 2025. The EC is expected to make a decision following CHMP recommendation and the decision will apply to all 27 European Union Member States, and also to Iceland, Norway and Liechtenstein. 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 one million patient lives in post-marketing use in ten commercialized products in at least one major region and 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 Teva Pharmaceuticals and McDermott Laboratories Limited, an affiliate of Viatris Inc. 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, including a potential reduction in administration time and broadening the treatment options for the indication referred to in this press release. Forward-looking statements may also include statements regarding the product development efforts of Halozyme's ENHANZE® partner and the potential approval of an extension of marketing authorization for the subcutaneous formulation referred to in this press release and the timing of such potential approval. 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 "expect," "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 extension of marketing authorization for the subcutaneous formulation referred to in this press release is delayed or ultimately approved, unexpected results or delays in the launch or commercialization of our partner's product for the indication referred to in this press release, unexpected adverse events or patient experiences or 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 609-333-7668 [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

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