Collaborations and licenses
At argenx, our approach to collaboration and licensing is rooted in the conviction that progress accelerates when boundaries are challenged and expertise is shared. We follow a disciplined strategy to maximize the value of our pipeline. We retain full development and commercialization rights for programs where we believe our platform and capabilities can deliver the greatest impact, ensuring we capture the full value of our innovation. At the same time, we actively seek out partnerships with organizations that share our drive to redefine what’s possible, leveraging complementary strengths to unlock new opportunities for patients.
Our licensing strategy is dynamic and pragmatic: we license out select intellectual property to expand the reach of our science, while we also in-license or acquire technologies and assets that can amplify our pipeline or accelerate development. We have partnered, and plan to continue to partner, to develop products and product candidates that we believe have promising utility in disease areas or have patient populations that may benefit from resources of other biopharmaceutical companies. We believe every agreement is shaped by a clear-eyed focus on execution, mutual benefit, and the potential to create lasting change. We aim to be disciplined in our diligence and financial commitments, but not at the expense of agility or ambition. By building alliances that transcend traditional hierarchies and by staying relentlessly focused on unmet needs, we are not just advancing our own portfolio, we are helping to reshape the landscape of immunology for the long term.
We also have several license agreements in place, under which we license patents, patent applications and other intellectual property to third parties. We have also entered into several license agreements under which we license patents, patent applications and other intellectual property from third parties. License agreements can relate to research and development and/or commercialization of the relevant product candidates (and technologies) or products. The licensed intellectual property covers some of our product candidates and some of the antibody engineering technologies that we use. Some of these licenses impose various diligence and financial payment obligations on us. We expect to continue to enter into these types of license agreements in the future.
We have entered into multiple collaboration agreements with pharmaceutical partners and license agreements, some of which are described below.
Our Strategic Partnership with Zai Lab for efgartigimod
Pursuant to the Zai Lab Agreement, Zai Lab obtained the exclusive right to develop and commercialize efgartigimod in Greater China. Zai Lab will also contribute patients to our global Phase 3 clinical trials of efgartigimod. Our Zai Lab strategic collaboration allows us to accelerate development of efgartigimod into new autoimmune indications with Zai Lab taking operational leadership of selected Phase 2 POC Clinical trials.
We are eligible to receive a one-time sales based milestone and tiered royalties based on annual net sales of efgartigimod in Greater China thereafter.
Our Exclusive License with Halozyme for ENHANZE®
In February 2019, we entered into an in-license agreement with Halozyme for the use of certain patents, materials and know-how owned by Halozyme and relating to its ENHANZE®, for application in the field of prevention and treatment of human diseases (the ENHANZE® License Agreement). Pursuant to the ENHANZE® License Agreement, we were granted exclusive rights to apply ENHANZE® to biologic products against pre-specified targets, in order to research, develop and commercialize SC formulations of our therapeutic antibody-based product candidates.
Our first therapeutic target for which we received an exclusive license from Halozyme was FcRn, which allows us to apply ENHANZE® to efgartigimod and any other product candidates selective and specific for FcRn. Moreover, the breadth of our exclusive license to FcRn precludes either Halozyme itself or any of its current or future partners from utilizing ENHANZE® in the context of an FcRn-targeted product. Our second therapeutic target for which we received an exclusive license from Halozyme was human C2 associated with the product candidate empasiprubart, which is being developed to treat severe autoimmune diseases. Pursuant to the ENHANZE® License Agreement, we also have the right to nominate future targets for an exclusive ENHANZE® license if the target in question has not already been licensed by Halozyme or is not already being pursued by Halozyme.
We have expanded our collaboration with Halozyme for ENHANZE® drug delivery technology to additional targets for a total of six, including FcRn and C2.
We may terminate the ENHANZE® License Agreement at any time, either in its entirety or on a target-by-target basis, by sending Halozyme prior written notice. Absent early termination, the ENHANZE® License Agreement will automatically expire upon the expiry of our royalty payment obligations under the agreement. In the event the ENHANZE® License Agreement is terminated for any reason, the license granted to us would terminate but Halozyme would grant our sublicensees a direct license following such termination. In the event the ENHANZE® License Agreement is terminated other than for our breach, we would retain the right to sell licensed products then on hand for a certain period of time post-termination.
Our Exclusive License with the University of Texas for NHANCE™ and ABDEG™
In February 2012, we entered into an exclusive in-license with the Board of Regents of the University of Texas System (UT BoR) for the use of certain patent rights relating to the NHANCE™ platform for any use worldwide (the UT Agreement). The UT Agreement was amended on December 23, 2014 to also include certain additional patent rights relating to the ABDEG™ platform. Upon commercialization of any of our products that use the in-licensed patent rights, we will be obligated to pay UT BoR a percentage of net sales as a royalty until the expiration of any patents covering the product. This royalty varies with net sales volume and is subject to an adjustment for royalties we receive from a sublicensee of our rights under the UT Agreement, but in any event does not exceed 1%. In addition, we must make annual license maintenance payments to UT BoR until termination of the UT Agreement and we have assumed certain development and commercial milestone payment and reimbursement obligations. We also have diligence requirements with respect to development and commercialization of products which use the in-licensed patent rights.
Pursuant to the UT Agreement, we may grant sublicenses to third parties. If we receive any non-royalty income in connection with such sublicenses, we must pay UT BoR a percentage of such income varying from low-middle single digits to middle-upper single digits depending on the nature of the sublicense. Such fees are waived if a sublicensee agrees to pay the milestone payments as set forth in the UT Agreement.
We may unilaterally terminate the UT Agreement for convenience upon prior written notice. Absent early termination, the UT Agreement will automatically expire upon the expiration of all issued patents and filed patent applications within the patent rights covered by the UT Agreement. Our royalty payment obligations expire, on a product-by-product and country-by-country basis, at such time as there are no valid claims covering such product.
OncoVerity for cusatuzumab
In 2022, we, the University of Colorado Anschutz Medical Campus and the University of Colorado Health (UCHealth) created an asset-centric spin-off, OncoVerity, Inc (OncoVerity), focused on optimizing and advancing the development of cusatuzumab, a novel anti-CD70 antibody, in acute myeloid leukemia (AML). OncoVerity is an entity of co-creation, combining the extensive translational biology insights from Dr. Clayton Smith, M.D. from the University of Colorado with our experience on the CD70/CD27 pathway.
In 2023, we granted an exclusive license for cusatuzumab to OncoVerity and provided, together with a joint venture of University of Colorado Health and University License Equity Holdings, Inc. on the University of Colorado Anschutz Medical Campus, and funding for ongoing clinical development of cusatuzumab.
In 2024 and 2025, we participated in a further funding round to support the continued, ongoing, clinical development of cusatuzumab by OncoVerity.
Our Strategic Partnership with AbbVie for ARGX-115 (ABBV-151)
In 2016, we entered into a collaboration agreement with AbbVie for ARGX‑115 (ABBV‑151), targeting GARP in oncology (the AbbVie Collaboration Agreement). After completing IND‑enabling work, AbbVie exercised its option and assumed full responsibility for global development and commercialization. We are eligible for up to $625 million in potential development, regulatory and commercial milestones, plus tiered royalties from the mid‑single digits to lower teens. We also retain co‑promotion rights in the EEA and Switzerland. The agreement continues on a product‑by‑product basis until AbbVie’s payment obligations expire, and AbbVie may terminate the AbbVie Collaboration Agreement with prior notice.