With a recently acquired FDA nod for its Halozyme Therapeutics-partnered Vyvgat Hytrulo, argenx is looking to take Halozyme’s delivery tech to new heights through a $30 million licensing deal that covers four more targets.
For $7.5 million per target and milestone payments that could reach up to $85 million per target, argenx can now claim exclusive access to Halozyme’s Enhanze subcutaneous drug delivery technology. The new agreement brings the total number of targets under the collaboration up to six.
The royalty rate for all products included in the deal is a tiered mid-single digit rate based on annual net sales until Halozyme’s Enhanze-related patents expire, after which the royalty rate will scale down in “one or more steps,” according to a company release.
"We are very excited to have access to Halozyme's leading subcutaneous delivery technology now for six different targets,” argenx CEO Tim Van Hauwermeiren noted in the release. “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."
Halozyme, meanwhile, is “very pleased” to strengthen its relationship with argenx, CEO Helen Torley added. “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."
Argenx’s recently unveiled Vision 2030 strategy sets a 2030 goal of five new preclinical assets in phase 3 development, 10 approved indications across its flagship drug Vyvgart and other launches and 50,000 patients on an argenx therapy.
Key to the plan will be locking down more patients for Vyvgart in generalized myasthenia gravis (gMG), which it won its original approval for in 2021, and in rare nervous system disease chronic inflammatory demyelinating polyneuropathy (CIDP), among other potential indications.
In June, subcutaneous Vyvgart Hytrulo snagged an FDA greenlight for CIDP, a breakthrough in the disease after three decades of “very little meaningful innovation,” argenx’s VP of global medical affairs & evidence generation Susan Begelman, M.D., said on a media call at the time. The nod came with a “best-case scenario broad label,” William Blair analysts wrote in a note to clients ahead of the approval.
The company looks to reach a total addressable population of 24,000 treated CIDP patients out of 41,000 diagnosed and will initially target 12,000 patients whose disease is not well-managed on current therapy, the analysts pointed out.
Outside of argenx, Halozyme has also licensed its Enhanze technology to several prominent drugmakers including Roche, Takeda, Pfizer, Johnson & Johnson, AbbVie, Eli Lilly and Bristol Myers Squibb, among others, as well as markets its own products.
Most recently, Halozyme’s Roche partnership bore fruit after manufacturing delays hampered an initial launch of Tecentriq Hyberza. The subcutaneous version scored FDA approval in all of Tecentriq’s adult formulation indications, including types of lung, liver, skin and soft tissue cancers and speeds up injection time to seven minutes as opposed to the 30 to 60 minutes needed for an IV infusion.