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Vanda expects to immediately begin preparing BLA and MAA applications for the U.S. and EU.
February 3, 2025
By: Charlie Sternberg
Vanda Pharmaceuticals Inc. and AnaptysBio Inc. have 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 evaluating the safety and efficacy of imsidolimab in patients with Generalized Pustular Psoriasis (GPP).
GPP is a rare skin disorder caused by mutations in the IL36RN gene, which codes for a protein regulating the IL-36 cytokines. This dysregulation triggers severe chronic inflammation, pustules, and systemic symptoms, leading to significant morbidity and mortality associated with sepsis and multi-organ failure.
Imsidolimab inhibits IL-36R function, compensating for the IL-36 regulator deficiency in GPP patients, and has completed its development program, including the GEMINI-1 and GEMINI-2 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 U.S. 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 colitis.”
“Vanda is an ideal partner for imsidolimab due to their strong regulatory and commercial capabilities in the U.S. 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,” said Daniel Faga, president and chief executive officer of Anaptys. “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.”
Under the terms of the agreement, Vanda will make to Anaptys an upfront payment of $10 million and a $5 million payment for existing drug supply. Anaptys is also eligible to receive up to $35 million for future regulatory approval and sales milestones in addition to a 10% royalty on net sales. Vanda will receive an exclusive global license to develop, manufacture and commercialize imsidolimab.
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