Biodel Inc. (Nasdaq:BIOD) today announced another development in its Glucagon Emergency Management (GEM) development program with the signing of a long-term manufacturing agreement with Cangene bioPharma Inc. doing business as Emergent BioSolutions ("Emergent"). Under the agreement, Emergent will fill and finish commercial quantities of the GEM device. Financial terms of the agreement have not been disclosed.
The GEM device, to which Biodel holds exclusive rights for use with glucagon, is a customized version of Unilife's dual-chamber auto-reconstitution syringe. GEM is being developed for use as a rescue treatment for severe hypoglycemia. GEM is an intuitive, easy-to-use device designed to address and expand a market underserved by the currently available kits that are difficult to assemble and operate during an emergency.
This fill and 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 anticipated submission of a New Drug Application to the FDA in 2015 and subsequent commercial launch.
Dr. Errol De Souza, Biodel's president and chief executive officer, stated: "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."