Biodel Signs Fill-Finish Pact with Emergent BioSolutionsBy
The biopharmaceutical company Biodel Inc. has signed a long-term manufacturing agreement with Emergent BioSolutions under which Emergent will fill-finish commercial quantities of Biodel’s glucagon emergency management (GEM) development 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 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-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.
Emergent enhanced its fill- finished capabilities with the acquisition of