The trials assessed the efficacy and safety of the therapy in patients with GPP, a severe skin disorder. Credit: Kmpzzz/Shutterstock.

Vanda Pharmaceuticals and AnaptysBio have announced an exclusive worldwide licence agreement to develop and commercialise the fully humanised immunoglobulin G4 (IgG4) antibody, imsidolimab, to treat the severe skin disorder generalised pustular psoriasis (GPP).

The agreement follows the completion of two Phase III trials, GEMINI-1 and GEMINI-2, which assessed the efficacy and safety of the therapy.

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Vanda will pay AnaptysBio $10m upfront along with a $5m payment for the current drug supply.

Anaptys will receive future regulatory approval and sales milestones amounting to $35m, along with a 10% net sales royalty.

With this deal, Vanda secures the rights to develop, manufacture and commercialise imsidolimab globally.

Vanda Pharmaceuticals president, CEO and board chairman Mihael Polymeropoulos stated: “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.”

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Guggenheim Securities and Fenwick & West served as financial advisor and legal counsel respectively to AnaptysBio during the transaction.

Vanda was advised by Cantor Fitzgerald & Co. Orrick, Herrington & Sutcliffe provided legal counsel.

By blocking IL-36R, Imsidolimab corrects the deficiency of the endogenous IL-36 regulator in GPP patients.

With the development programme, including the GEMINI-1 and GEMINI-2 Phase III studies, now concluded, Vanda is preparing for technology transfer activities in 2025.

The company will begin preparing the marketing authorisation application (MAA) and biologics licence application (BLA) for regulatory submission in the EU and the US.

Regulatory and patent exclusivity for imsidolimab is anticipated to extend into the 2030s.

In December 2023, the US Food and Drug Administration accepted a new drug application from Vanda for tradipitant, aimed at treating gastroparesis.