The pen injector is being developed under a licensing agreement signed in January 2008 between the companies where Antares will supply a custom proprietary pen for two self-administered drugs that ultimately will be marketed by Teva. The filing was a requisite part of the overall product development plan and Antares delivered this on schedule.
This is the second device master file that Antares has submitted as part of its Teva collaborations and increases the number of product specific devices that have been the subject of device master file submissions with the FDA to three. Details of the financial terms were not disclosed.
Paul Wotton, president and CEO of Antares Pharma, said: “The true value of triggering this milestone payment is both the achievement of a regulatory filing in a short period of time and the important product design objectives that we have been able to reach since signing the agreement with Teva.”