argenx and Halozyme enter global collaboration and license agreement for ENHANZE technology

argenx and Halozyme Therapeutics announced a global collaboration and license agreement that enables use by argenx of Halozyme’s ENHANZE drug delivery technology to develop multiple subcutaneous product formulations for current or future argenx product candidates. The agreement provides argenx exclusive access to ENHANZE for any product targeting the human neonatal Fc receptor FcRn, including argenx’s lead asset efgartigimod (ARGX-113) and up to two additional targets, potentially shortening drug administration time, reducing healthcare practitioner time, and offering additional flexibility and convenience for patients.

Under the terms of the agreement, argenx will pay an upfront payment of $30 million to Halozyme, $10 million per target for future target nominations and potential future payments of up to $160 million per selected target subject to achievement of specified development, regulatory and sales-based milestones. Halozyme will also receive mid-single digit royalties on sales of commercialized products.

“Through our collaboration with Halozyme, a company that has transformed subcutaneous delivery of biologics, we now have the potential to add optimal delivery capabilities to our profile of building best-in-class antibodies against novel targets. By gaining exclusive access to ENHANZE technology for our anti-FcRn asset, we also solidify our leadership position in this exciting new space that has the potential to disrupt the way severe autoimmune diseases are treated,” commented Keith Woods, Chief Operating Officer of argenx. “As we look towards commercialization, if approved, efgartigimod is now equipped with a well-established subcutaneous delivery technology in addition to the clinical activity and favorable tolerability profile we have observed in studies to date. We believe that by offering both intravenous and subcutaneous formulations, we have the opportunity to capture patient preferences across all indications within our efgartigimod portfolio.”

“We are excited to work with argenx to create new delivery options for therapies being developed to improve the lives of patients suffering from severe autoimmune diseases,” said Dr. Helen Torley, President and CEO of Halozyme. “This collaboration is an example of the value ENHANZE can potentially bring while a product is still in development where the benefits of subcutaneous administration can be realized earlier by both patients and healthcare providers.”

argenx represents Halozyme’s ninth global collaboration and license partner for the ENHANZE technology. These collaborations cover more than 50 therapeutic targets and include three commercialized products.

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