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Spying new horizons, Xeris starts work on subcutaneous version of rare disease drug

Horizon Therapeutics has teamed up with Xeris Biopharma to create an ultra-concentrated, ready-to-use, subcutaneous formulation of teprotumumab, handing over an upfront payment and offering milestones to get its new partner to apply XeriJect to the molecule.

Teprotumumab, an anti-IGF-1R blocking antibody, came to market in 2020 as a treatment for the rare condition thyroid eye disease. The molecule, which Horizon sells as Tepezza, is given as an intravenous infusion. Patients receive eight infusions with three-week gaps between sessions. The first two infusions take about 90 minutes. The remaining six last around 60 minutes, although they can be longer.

The intravenous dosing schedule suggests a subcutaneous formulation may significantly reduce the time people spend getting treated, lifting a burden from patients and potentially improving adherence. Even relatively large volume subcutaneous drugs are typically administered in five minutes or less.

Xeris will use XeriJect to try to develop a subcutaneous formulation of teprotumumab. Using drying or particle engineering techniques, Xeris creates powders ready for “wetting” with biocompatible diluents. The process yields ultra-concentrated, low-volume paste formulations suitable for subcutaneous or intravenous delivery. Xeris has formulated suspensions with protein concentrations of 400 mg/mL or more.

Horizon will have an option to license the Xeris technology. In return, Horizon has paid an upfront fee and committed to development, regulatory and sales milestones, plus royalties. Xeris CEO Paul Edick explained the significance of the deal for his company.

“This partnership demonstrates the potential value of our technology to enable large molecule subcutaneous injections that provide a more patient friendly regimen that is effective, safe, and more convenient, with potential for improved adherence,” Edick said in a statement.