argenx & Halozyme Enter Global Collaboration & License Agreement

argenx and Halozyme Therapeutics, Inc. recently 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,” said Keith Woods, Chief Operating Officer of argenx. “As we look toward 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.

Halozyme’s proprietary ENHANZE drug delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.

Halozyme Therapeutics is a biotechnology company focused on developing and commercializing novel oncology therapies that target the tumor microenvironment. Halozyme’s lead proprietary program, investigational drug pegvorhyaluronidase alfa (PEGPH20), applies a unique approach to targeting solid tumors, allowing increased access of co-administered cancer drug therapies to the tumor in animal models. PEGPH20 is currently in development for the treatment of several cancers and has the potential to be used in combination with different types of cancer therapies. In addition to its proprietary product portfolio, Halozyme has established value-driving partnerships with leading pharmaceutical companies, including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion and argenx, for its ENHANZE drug delivery technology. For more information visit www.halozyme.com.

argenx is a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer. The company is focused on developing product candidates with the potential to be either first-in-class against novel targets or best-in-class against known, but complex, targets in order to treat diseases with a significant unmet medical need. argenx’s ability to execute on this focus is enabled by its suite of differentiated technologies. The SIMPLE Antibody Platform, based on the powerful llama immune system, allows argenx to exploit novel and complex targets, and its three complementary Fc engineering technologies are designed to expand the therapeutic index of its product candidates. For more information, visit www.argenx.com.