Vanda Pharmaceuticals and Anaptys Announce Exclusive Global License Agreement for Vanda to Develop and Commercialize Imsidolimab, an IL-36R Antagonist
Vanda Pharmaceuticals (VNDA) and AnaptysBio announced an exclusive global license agreement for imsidolimab, an IL-36R antagonist that has completed two Phase 3 trials for Generalized Pustular Psoriasis (GPP). Under the agreement, Vanda will pay $15 million upfront ($10M payment plus $5M for drug supply) and will receive exclusive global rights to develop, manufacture, and commercialize imsidolimab.
The drug has successfully completed GEMINI-1 and GEMINI-2 global Phase 3 trials for GPP, a rare skin disorder affecting between 1.76 and 124 patients per million people worldwide. Vanda plans to prepare BLA and MAA applications for US and EU markets in 2025. AnaptysBio is eligible for up to $35 million in future regulatory and sales milestones, plus a 10% royalty on net sales.
Vanda Pharmaceuticals (VNDA) e AnaptysBio hanno annunciato un accordo di licenza globale esclusivo per imsidolimab, un antagonista dell'IL-36R che ha completato due studi di Fase 3 per la Psoriasi Pustolosa Generalizzata (GPP). In base all'accordo, Vanda pagherà 15 milioni di dollari in anticipo (10 milioni di dollari più 5 milioni di dollari per la fornitura del farmaco) e riceverà diritti globali esclusivi per sviluppare, produrre e commercializzare imsidolimab.
Il farmaco ha completato con successo gli studi globali di Fase 3 GEMINI-1 e GEMINI-2 per la GPP, una rara malattia della pelle che colpisce tra 1,76 e 124 pazienti ogni milione di persone nel mondo. Vanda prevede di preparare le domande BLA e MAA per i mercati statunitensi ed europei nel 2025. AnaptysBio è idonea a ricevere fino a 35 milioni di dollari in futuri obiettivi normativi e di vendite, oltre a una royalty del 10% sui ricavi netti.
Vanda Pharmaceuticals (VNDA) y AnaptysBio anunciaron un acuerdo de licencia global exclusivo para imsidolimab, un antagonista de IL-36R que ha completado dos ensayos de Fase 3 para la Psoriasis Pustulosa Generalizada (GPP). Según el acuerdo, Vanda pagará 15 millones de dólares por adelantado (10 millones de dólares más 5 millones de dólares para el suministro del fármaco) y recibirá derechos globales exclusivos para desarrollar, fabricar y comercializar imsidolimab.
El medicamento ha completado con éxito los ensayos globales de Fase 3 GEMINI-1 y GEMINI-2 para GPP, una rara enfermedad de la piel que afecta a entre 1,76 y 124 pacientes por cada millón de personas en todo el mundo. Vanda planea preparar solicitudes BLA y MAA para los mercados de EE. UU. y UE en 2025. AnaptysBio es elegible para hasta 35 millones de dólares en futuros hitos regulatorios y de ventas, además de un royalty del 10% sobre las ventas netas.
반다 제약(VNDA)와 아나프티스바이오가 일반화된 농포성 피부염(GPP)에 대한 IL-36R 길항제인 임시둘리맙에 대한 독점 글로벌 라이선스 계약을 발표했습니다. 계약에 따라 반다는 1500만 달러를 선불로 지급하며(1천만 달러 지급 및 5백만 달러의 약물 공급비 포함) 임시둘리맙을 개발, 제조 및 상용화할 독점 글로벌 권리를 받게 됩니다.
이 약물은 GPP에 대한 글로벌 3상 시험인 GEMINI-1 및 GEMINI-2를 성공적으로 완료했습니다. GPP는 전 세계적으로 백만 명당 1.76에서 124명 사이의 환자에게 영향을 미치는 희귀한 피부 질환입니다. 반다는 2025년까지 미국 및 유럽 시장을 위한 BLA 및 MAA 신청서를 준비할 계획입니다. 아나프티스바이오는 향후 3500만 달러의 규제 및 판매 기준 마일스톤과 순매출의 10%에 해당하는 로열티를 받을 수 있습니다.
Vanda Pharmaceuticals (VNDA) et AnaptysBio ont annoncé un accord de licence exclusif mondial pour l'imsidolimab, un antagoniste de l'IL-36R qui a terminé deux essais de Phase 3 pour le psoriasis pustuleux généralisé (GPP). Selon l'accord, Vanda paiera 15 millions de dollars d'avance (10 millions de dollars de paiement plus 5 millions de dollars pour la fourniture de médicaments) et recevra des droits mondiaux exclusifs pour développer, fabriquer et commercialiser l'imsidolimab.
Le médicament a terminé avec succès les essais mondiaux de Phase 3 GEMINI-1 et GEMINI-2 pour le GPP, une maladie cutanée rare affectant entre 1,76 et 124 patients pour un million de personnes dans le monde. Vanda prévoit de préparer des demandes BLA et MAA pour les marchés américain et européen en 2025. AnaptysBio est éligible à jusqu'à 35 millions de dollars en futures étapes réglementaires et commerciales, en plus d'un droit de 10 % sur les ventes nettes.
Vanda Pharmaceuticals (VNDA) und AnaptysBio haben einen exklusiven globalen Lizenzvertrag für Imsidolimab, ein IL-36R-Antagonist, der zwei Phase-3-Studien zur allgemeinen pustulösen Psoriasis (GPP) abgeschlossen hat, angekündigt. Im Rahmen des Vertrags wird Vanda 15 Millionen Dollar im Voraus zahlen (10 Millionen Dollar plus 5 Millionen Dollar für die Medikamentenversorgung) und erhält exklusive globale Rechte zur Entwicklung, Herstellung und Vermarktung von Imsidolimab.
Das Medikament hat erfolgreich die globalen Phase-3-Studien GEMINI-1 und GEMINI-2 für GPP abgeschlossen, eine seltene Hauterkrankung, die zwischen 1,76 und 124 Patienten pro Million Menschen weltweit betrifft. Vanda plant, 2025 Anträge für BLA und MAA für die US-amerikanischen und europäischen Märkte vorzubereiten. AnaptysBio hat Anspruch auf bis zu 35 Millionen Dollar zukünftige regulatorische und Verkaufsmeilensteine sowie eine 10%ige Lizenzgebühr auf den Nettoumsatz.
- Successful completion of two Phase 3 trials for imsidolimab
- Immediate preparation of BLA and MAA applications for US and EU markets
- Expansion of rare disease and anti-inflammatory portfolio
- Global exclusive rights secured for promising GPP treatment
- Significant upfront payment of $15 million required
- Additional milestone payments of up to $35 million
- 10% royalty obligation on future sales
- market size with GPP affecting only 1.76-124 patients per million
Insights
This licensing deal represents a strategically significant acquisition for Vanda Pharmaceuticals, securing a de-risked late-stage asset with immediate regulatory filing potential. The transaction structure is notably favorable, with
Several key value drivers make this deal particularly compelling:
- De-risked Asset: Imsidolimab has already completed two successful Phase 3 trials (GEMINI-1 and GEMINI-2), significantly reducing development risk
- Clear Regulatory Path: With a productive pre-BLA meeting already completed in 2024, the regulatory submission strategy is well-defined
- Market Opportunity: GPP affects between 1.76 and 124 patients per million population, suggesting a substantial rare disease market opportunity with competition
- Portfolio Synergy: The acquisition leverages Vanda's existing rare disease expertise and anti-inflammatory portfolio, including Ponvory®
The deal's structure suggests careful risk management by both parties. The modest upfront payment coupled with milestone-based payments aligns interests while preserving Vanda's capital. The
The immediate focus on BLA/MAA preparations indicates potential commercialization within 12-18 months, assuming standard regulatory review timelines. This acquisition could significantly impact Vanda's revenue potential in the rare disease space, particularly given the genetic basis of GPP and potential for precision medicine approaches.
- Imsidolimab has successfully completed two global Phase 3 studies in Generalized Pustular Psoriasis
- Vanda expects to immediately begin preparing BLA and MAA applications for the US and EU
- Anaptys to receive
$15 million $10 million $5 million - Anaptys to receive a
10% royalty on global net sales of imsidolimab
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 colitis."
GPP prevalence estimates in the general population vary considerably, between 1.76 and 124 patients per million persons worldwide.2 The majority of GPP cases are caused by genetic variants in IL36RN.3,4 Loss-of-function mutations in IL36RN are mostly missense mutations in a recessive pattern and result in unrestricted IL-36 activity.5,6
"GPP is a severely debilitating, life-threatening skin disease in need of novel therapeutic approaches," said Johann Gudjonsson, M.D., Ph.D., Arthur C. Curtis Professor of Molecular Skin Immunology and Scholar of the Taubman Medical Research Institute, University of
"Vanda is an ideal partner for imsidolimab due to their strong regulatory and commercial capabilities in the US and
Under the terms of the agreement, Vanda will make to Anaptys an upfront payment of
Guggenheim Securities acted as financial advisor and Fenwick & West LLP served as legal counsel to Anaptys on this transaction. Cantor Fitzgerald & Co. acted as financial advisor and Orrick, Herrington & Sutcliffe LLP served as legal counsel to Vanda.
About GEMINI-1 and GEMINI-2 Studies
In the 45-patient GEMINI-1 Phase 3 trial, patients were randomized 1:1:1 to receive a single infusion of 750mg intravenous (IV) imsidolimab, 300mg IV imsidolimab or placebo at Day 0. Of the patients who received a single dose of 750mg IV imsidolimab,
Sixteen GPPPGA 0/1 responder patients from GEMINI-1 were subsequently re-randomized to monthly maintenance dosing of either 200mg subcutaneous (SC) imsidolimab or placebo in the GEMINI-2 Phase 3 trial. Patients were followed for at least 24 weeks and up to a maximum of 92 weeks. Of the eight responding patients from GEMINI-1 who were re-randomized to monthly 200mg SC imsidolimab maintenance therapy,
Data from both trials demonstrated a consistent, favorable safety and tolerability profile with no treatment-related serious adverse events (SAEs) or SAEs leading to discontinuation reported in imsidolimab-treated patients.
About Imsidolimab and GPP
Imsidolimab is a fully humanized IgG4 antibody that inhibits the function of the interleukin-36-receptor, or IL-36R, that is being developed for the treatment of GPP. Regulatory and patent exclusivity is expected to extend into the late 2030s.
GPP is a rare, chronic, systemic autoinflammatory disease that is potentially life-threatening, if left untreated.
During a GPP flare, individuals experience the sudden eruption of painful pustules. These pustules appear over large areas of the skin, accompanied by redness, severe itchiness, and dry, cracked, or scaly skin. People with GPP may also experience more general symptoms such as fever, headache, extreme tiredness, or a burning sensation on the skin.
About Vanda Pharmaceuticals, Inc.
Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit www.vandapharma.com and follow us on X @vandapharma.
About Anaptys
Anaptys is a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics for autoimmune and inflammatory diseases. Its lead program, rosnilimab, a depleter and agonist targeting PD-1+ T cells, is in a Phase 2b trial for the treatment of rheumatoid arthritis and in a Phase 2 trial for the treatment of ulcerative colitis. Other antibodies in its portfolio include ANB033, an anti-CD122 antagonist, in a Phase 1 trial and ANB101, a BDCA2 modulator, soon to enter clinical development. Anaptys has also discovered multiple therapeutic antibodies licensed to GSK in a financial collaboration for immuno-oncology, including an anti-PD-1 antagonist (Jemperli (dostarlimab-gxly)) and an anti-TIM-3 antagonist (cobolimab, GSK4069889). To learn more, visit www.AnaptysBio.com or follow us on LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: the anticipated timing of the preparation and submission of regulatory filings in the US and EU and the initiation and completion of technology transfer activities; Vanda's plans with respect to its commercial launch activities; the estimated prevalence of GPP; the commercial availability of imsidolimab to treat patients with GPP; the potential for Anaptys to receive any royalties or milestone payments from the Vanda license agreement; and the potential for any patent life extension for imsidolimab. Statements including words such as "plan," "intend," "continue," "expect," or "ongoing" and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause each company's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to each company's ability to advance its product candidates, obtain regulatory approval of and ultimately commercialize each of its product candidates, the timing and results of preclinical and clinical trials, each company's ability to fund development activities and achieve development goals, each company's ability to protect intellectual property, and the accuracy of the of the estimates of the number of patients with GPP worldwide, and other risks and uncertainties described under the heading "Risk Factors" in documents each of the companies files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and each of the companies undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.
Vanda Pharmaceuticals Contact:
Kevin
Senior Vice President, Chief Financial Officer and Treasurer
202.734.3400
pr@vandapharma.com
Jim Golden / Jack Kelleher / Dan Moore
Collected Strategies
VANDA-CS@collectedstrategies.com
Anaptys Contact:
Nick Montemarano
Executive Director, Investor Relations
858.732.0178
investors@anaptysbio.com
References:
Armstrong , A. W. et al. Generalized pustular psoriasis: A consensus statement from the National Psoriasis Foundation. J Am Acad Dermatol 90, 727–730 (2024).- Prinz, J. C. et al. Prevalence, comorbidities and mortality of generalized pustular psoriasis: A literature review. Journal of the European Academy of Dermatology and Venereology 37, 256–273 (2022).
- Marrakchi, S. et al. Interleukin-36–Receptor Antagonist Deficiency and Generalized Pustular Psoriasis. New England Journal of Medicine 365, 620–628 (2011).
- Sugiura, K. et al. The Majority of Generalized Pustular Psoriasis without Psoriasis Vulgaris Is Caused by Deficiency of Interleukin-36 Receptor Antagonist. Journal of Investigative Dermatology 133, 2514–2521 (2013).
- Lee, C.-C., Huang, Y.-H., Chi, C.-C., Chung, W.-H. & Chen, C.-B. Generalized pustular psoriasis: immunological mechanisms, genetics, and emerging therapeutics. Trends Immunol 46, 74–89 (2025).
- Sachen, K. L., Arnold Greving, C. N. & Towne, J. E. Role of IL-36 cytokines in psoriasis and other inflammatory skin conditions. Cytokine 156, 155897 (2022).
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SOURCE Vanda Pharmaceuticals Inc.
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