medmix AG

medmix's Drug Delivery unit, known as Haselmeier, announced a collaboration with Xeris Pharmaceuticals to support development of Xeris' XP-8121, an investigational once-weekly subcutaneous levothyroxine therapy for hypothyroidism. The collaboration will leverage medmix's D-Flex disposable pen platform, which in design verification testing achieved dose accuracy significantly exceeding ISO 11608-1 requirements, the international standard for dose accuracy in needle-based injection systems. Because the U.S. Food and Drug Administration has classified levothyroxine as a drug with a narrow therapeutic index, accurate dose delivery is critical, as small differences in dose or blood concentration can lead to over- or undertreatment and adverse effects. The D-Flex platform incorporates a patented dosing mechanism that allows patients to select only intended dose settings, supports multiple fixed-dose configurations within a single device design, and enables administration of very small dose increments down to 0.005 mL, with adaptability for dose volumes up to 0.75 mL. Pete Valentinsson, Senior Vice President of Global Technical Operations at Xeris, said D-Flex distinguished itself by consistently demonstrating the dose accuracy XP-8121 demands, while Dr. Oliver Haferbeck, Head of Business Unit Drug Delivery at medmix, said the company is proud to support Xeris with a platform that has demonstrated outstanding dose accuracy. D-Flex has been marketed since 2023 and is already deployed in an approved European product variant and an ongoing U.S. clinical program.