Vanda and AnaptysBio Finalise Exclusive Licence Agreement for Imsidolimab in Rare Skin Disease

• Vanda Pharmaceuticals has secured an exclusive global licence for the development and commercialisation of imsidolimab from AnaptysBio.

• Imsidolimab, an IL-36R antagonist monoclonal antibody, has successfully completed Phase 3 trials for generalised pustular psoriasis (GPP), a rare and life-threatening skin disorder.

Vanda Pharmaceuticals has signed an exclusive, global licence agreement with AnaptysBio for the development and commercialisation of imsidolimab, an IL-36R antagonist monoclonal antibody. The agreement grants Vanda full rights to imsidolimab, which has successfully completed two registration-enabling Phase 3 trials—GEMINI-1 and GEMINI-2—evaluating its efficacy and safety in treating generalised pustular psoriasis (GPP).

GPP is a severe and potentially fatal skin disease, often linked to mutations in the IL36RN gene, which disrupts IL-36 signalling and triggers systemic inflammation. Imsidolimab, by inhibiting IL-36R, addresses this imbalance and has shown promise in clinical trials. According to Vanda, preparations for Biologics License Application (BLA) and Marketing Authorisation Application (MAA) submissions in the US and EU are set to begin in 2025, alongside technology transfer activities and commercial readiness efforts.

Vanda’s President, CEO, and Chairman, Dr Mihael H. Polymeropoulos, highlighted the potential of imsidolimab in addressing inflammatory diseases beyond GPP. “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,” he said.

Under the agreement, AnaptysBio will receive an upfront payment of $10 million and an additional $5 million for existing drug supply. The deal also includes up to $35 million in regulatory and sales milestones, along with a 10% royalty on net sales.

“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,” 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.”