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Vanda Pharmaceuticals and Anaptys Announce Exclusive Global License Agreement for Vanda to Develop and Commercialize Imsidolimab, an IL-36R Antagonist
Imsidolimab has successfully completed two global Phase 3 studies in Generalized Pustular PsoriasisVanda expects to immediately begin preparing BLA and MAA
About this update from Vanda Pharmaceuticals Inc.
[{"type":"text","content":"Imsidolimab has successfully completed two global Phase 3 studies in Generalized Pustular PsoriasisVanda expects to immediately begin preparing BLA and MAA applications for the US and EUAnaptys to receive $15 million from Vanda, comprised of a $10 million upfront payment and $5 million for existing drug supplyAnaptys to receive a 10% royalty on global net sales of imsidolimab WASHINGTON and SAN DIEGO, Feb. 03, 2025 (GLOBE NEWSWIRE) -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) and AnaptysBio, Inc. (Anaptys) (Nasdaq: ANAB) today announced an exclusive, global license agreement for the development and commercialization of imsidolimab (IL-36R antagonist mAb), which has successfully completed two registration-enabling global Phase 3 trials, GEMINI-1 and GEMINI-2, evaluating the safety and efficacy of imsidolimab in patients with Generalized Pustular Psoriasis (GPP). GPP is a rare skin disorder often caused by mutations in the IL36RN gene that codes for a regulatory protein that balances the activity of the proinflammatory IL-36 family of cytokines. Dysregulation of this balance in IL-36 signaling leads to severe chronic skin inflammation with pustules and systemic symptoms which carry significant morbidity and mortality often associated with sepsis and multi-organ failure.1 Imsidolimab inhibits the function of the IL-36R, compensating for the deficiency of the endogenous IL-36 regulator in patients with GPP. Imsidolimab has successfully concluded its development program in GPP, including the GEMINI-1 and GEMINI-2 global Phase 3 studies. In 2025, Vanda intends to initiate and complete the technology transfer activities and will immediately begin preparing the BLA and MAA applications for the US and EU and making preparations for commercialization. “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,” said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board. “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 co...