Halozyme Announces Expansion of Global Collaboration and License Agreement with argenx for ENHANZE®

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Oct 03, 2024, 08:00 ET

Four new targets nominated for total of six nominated targets, including FcRn (VYVGART^® Hytrulo), for ENHANZE^® drug delivery technology

Halozyme to receive total upfront payment of $30 million for exclusive rights to targets

SAN DIEGO, Oct. 3, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that argenx has nominated four new targets under its global collaboration and license agreement that provides argenx exclusive access to Halozyme's ENHANZE^® drug delivery technology, a proprietary recombinant human hyaluronidase PH20 enzyme (rHuPH20) for rapid subcutaneous drug delivery. argenx, a global immunology company, now has exclusively licensed ENHANZE^® for a total of six targets, including for the neonatal Fc receptor (FcRn) target. VYVGART^® Hytrulo, argenx's branded FcRn blocker, is approved by the U.S. Food and Drug Administration for chronic inflammatory demyelinating polyneuropathy and generalized myasthenia gravis, with additional approvals granted in >25 countries globally for the latter indication.

Under the terms of the expanded exclusive agreement, argenx will make upfront payments of $7.5 million per target nomination for a total of $30 million to Halozyme, and potential future milestone payments related to development progress, regulatory approvals, and sales attainment of up to $85 million per nominated target.

The royalty rate for all products under the agreement is a tiered mid-single digit rate based on annual net sales until expiration of Halozyme's ENHANZE^® related patents, when the rate will be reduced in one or more steps. Royalties will be paid for the longer of 10 years from the first commercial sale or until the expiration of the last valid claim of a co-formulation patent.

"We are very pleased to strengthen our relationship with argenx, an innovative leader in immunology dedicated to improving the lives of people suﬀering from severe autoimmune diseases. We share argenx's patient centric mission and are united in our commitment to improve the lives of patients. As the leader in rapid subcutaneous drug delivery, ENHANZE has clinically demonstrated shorter administration time, offering patients and healthcare practitioners with more convenience and flexibility in how therapies are delivered," said Dr. Helen Torley, president and chief executive officer. "With the strong proven success of ENHANZE, we look forward to further supporting argenx's momentum as they expand their immunology pipeline with subcutaneous delivery of therapeutics to achieve their Vision 2030."

Tim Van Hauwermeiren, Chief Executive Officer of argenx, added, "We are very excited to have access to Halozyme's leading subcutaneous delivery technology now for six different targets. The expansion of our exclusive access to ENHANZE plays a critical role in solidifying our leadership position and delivering on our commitment to providing life-changing immunology solutions to patients."

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 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 and administration of larger volumes of injectable medications through subcutaneous delivery and potentially lowering the treatment burden for patients. These forward-looking statements also include statements regarding the product development and commercialization efforts of Halozyme's ENHANZE^® partner (including the potential regulatory approval and launch of ENHANZE^® products as a result of such efforts and the potential future market opportunity for such products) and Halozyme's potential receipt of an upfront payment and payments associated with achievement of certain development, regulatory and sales-based milestones, and royalties on sales of commercialized products. 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 development, regulatory and sales-based milestones will be achieved, uncertainties concerning whether collaborative products are ultimately developed, approved or commercialized and the potential future market for such products, unexpected expenditures and costs, unexpected results or delays in development and regulatory review, unexpected 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 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]

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

SOURCE Halozyme Therapeutics, Inc.