Halozyme Announces Takeda Received European Commission Approval for HYQVIA® Co-formulated with ENHANZE® as Maintenance Therapy for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

SAN DIEGO, Jan. 29, 2024 /PRNewswire/ — Halozyme Therapeutics, Inc. (NASDAQ: HALO) (“Halozyme”) today announced that Takeda received European Commission (EC) approval for HYQVIA^® [Immune Globulin Infusion 10% (Human)] co-formulated with Halozyme’s ENHANZE^® drug delivery technology as maintenance therapy in patients of all ages with chronic inflammatory demyelinating polyneuropathy (CIDP) after stabilization with intravenous immunoglobulin therapy (IVIG). HYQVIA^® also recently received U.S. Food and Drug Administration (FDA) approval as maintenance therapy for adults with CIDP.

HYQVIA^® is the only FDA and now EC-approved combination of immunoglobulin (IG) and hyaluronidase for CIDP and is administered by facilitated subcutaneous infusion. For patients with CIDP, HYQVIA^® can be infused up to once monthly (every two, three or four weeks). HYQVIA^® can be administered by a healthcare professional or self-administered in the patient’s home after appropriate training.

“The demand for new personalized maintenance treatment options for patients with CIDP continues to grow, and we are pleased to partner with Takeda to expand the HYQVIA offering to Europe,” said Dr. Helen Torley, president and chief executive officer of Halozyme.

The centralized marketing authorization for HYQVIA^® in CIDP is valid in all EU member states as well as in Iceland, Liechtenstein, Norway and Northern Ireland.

About Halozyme

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 800,000 patient lives in post-marketing use in seven 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, 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 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 Hylenex^® and XYOSTED^® and 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 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 concerning 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 aid in the dispersion and absorption of other injected therapeutic drugs, facilitating more rapid delivery and administration of higher volumes of injectable medications through subcutaneous delivery and certain other benefits of ENHANZE^® including lowering the treatment burden for patients and alleviating pressure on health care system resources, including potential out-of-hospital administration of HYQVIA^® . 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 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 and involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Actual results could differ materially from the 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 the Company’s partnered products, regulatory approval requirements, unexpected adverse events or patient outcomes and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission.

Contacts:

Tram Bui

VP, Investor Relations and Corporate Communications

609-359-3016

[email protected]

Samantha Gaspar

Teneo

617-877-9710

[email protected]

References:

European Medicines Agency. HyQvia product information.

HYQVIA^® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] U.S. Prescribing Information.