Unilife Corporation a U.S. based designer, developer and supplier of injectable drug delivery systems, has announced the signing of the first supply agreement under its November 2013 Master Development and Supply Agreement ("MDSA") with MedImmune, the global biologics research and development arm of AstraZeneca.
This supply agreement, executed on October 30, 2015, provides commercial terms for the long-term supply of a customized device from Unilife's Precision-Therapy™ platform of wearable injectors for a monoclonal antibody in late-stage clinical studies in MedImmune's pipeline.
The supply agreement follows the master terms defined in the MDSA for the customization and supply of Unilife's wearable injectors for use with MedImmune's drug candidates. The customization phase of the lead wearable injector program for Medimmune is now nearing completion and device production has begun at Unilife. Additionally, Unilife is shipping wearable injectors to MedImmune this quarter. In addition to development and material fees already paid by MedImmune, Unilife will begin generating revenue from the sale of these devices in the current quarter of this fiscal year.
Unilife has now completed its device component design verification and successful independent human factors studies for this device, as well as the qualification of filling of this wearable injector drug container for future filling on high-speed biopharmaceutical filling lines.
This new Supply Agreement provides minimum purchase commitments from MedImmune for the initial four years following the commercial launch of this biologic, and also has unit pricing for the devices.
Ian Hanson, Senior Vice-President and General Manager of Advanced Drug Delivery Systems at Unilife, said: "Unilife is pleased to be serving the needs of MedImmune, which has selected a customized device from our wearable injector platform for commercial use. We believe that
our prefilled, pre-assembled and simple-to-use wearable injectors represent an attractive technology to minimize risk and maximize convenience for patients."