Vanda Pharmaceuticals has signed an exclusive, global license agreement with AnaptysBio to develop and commercialise the latter’s IL-36R antagonist, imsidolimab.
Under the terms of the agreement, Vanda will get an exclusive license to develop, manufacture and commercialise imsidolimab worldwide.
In exchange, AnaptysBio will receive an upfront payment of $10m and a $5m payment for existing drug supply.
The antibody development company is also eligible to receive up to $35m for future regulatory approval and sales milestones in addition to a 10% royalty on net sales.
This year, Vanda plans to complete the technology transfer activities and will immediately start preparing the regulatory applications for imsidolimab in the US and EU.
Vanda president, CEO and board chairman Mihael Polymeropoulos said: “We are excited to add imsidolimab to Vanda’s product portfolio for rare orphan disorders, as well as explore the potential of this IL-36 signal regulator in the treatment of additional inflammatory conditions where the IL-36 homeostatic balance is dysregulated.
“Imsidolimab has great synergy with our commercial portfolio, leveraging both our rare disease expertise in the US and EU as well as the anti-inflammatory portfolio that includes Ponvory for multiple sclerosis, psoriasis and ulcerative colitis.”
Imsidolimab works by inhibiting the function of the interleukin-36 receptor (IL-36R), a protein that plays an important role in inflammation.
The inadequate balance of IL-36 signalling leads to severe chronic skin inflammation with pustules and systemic symptoms, morbidity and mortality linked to sepsis and organ failure.
The safety and efficacy of the drug has been validated in two global Phase 3 trials, GEMINI-1 and GEMINI-2, in patients with Generalized Pustular Psoriasis (GPP).
GPP is a rare skin disorder caused by mutations in the IL36RN gene, which translates a regulatory protein that balances the activity of the proinflammatory IL-36 family of cytokines.
Guggenheim Securities served as financial advisor and Fenwick & West as legal counsel to AnaptysBio on the transaction.
Also, Cantor Fitzgerald & Co. served as financial advisor and Orrick, Herrington & Sutcliffe LLP served as legal counsel to Vanda.
Anaptys president and CEO Daniel Faga said: “Vanda is an ideal partner for imsidolimab due to their strong regulatory and commercial capabilities in the US and Europe, evidenced by successful recent launches in specialty and rare diseases, and their commitment to invest in label expansion across their therapeutic portfolio, including their growing presence in inflammatory disease.
“Following our productive pre-BLA meeting with FDA in 2024, we look forward to Vanda’s BLA and MAA submissions later in 2025, with the hope that this potentially differentiated therapeutic option will be made available for patients living with GPP, a burdensome, and sometimes life-threatening skin disease.”
