Biodel’s GEM device is a customized version of Unilife's dual-chamber auto-reconstitution syringe, and is being developed for use as a rescue treatment for severe hypoglycemia. GEM is designed as an intuitive, easy-to-use device to address currently available kits that are considered difficult to assemble and operate during an emergency.
The fill/finish agreement, along with the previously-announced license and supply agreement for the GEM device with Unilife, and bulk glucagon supply agreement with Bachem, continue the company's preparation for the NDA submission anticipated in 2015 and subsequent commercial launch.
Dr. Errol De Souza, Biodel's president and chief executive officer, said, "We are pleased to reach another important milestone as we rapidly advance the commercialization of the first of our two unique glucagon rescue product candidates. We look forward to progressing through increasingly advanced stages of product development."