Boston, MA 03/06/2014 (wallstreetpr) – Biodel Inc (NASDAQ:BIOD) announced a new advance in its Glucagon Emergency Managemnt (GEM) development program as it signed a long term manufacturing deal with Cangene bioPharma Inc which does business as Emergent BioSolution.
The Agreement
According to the deal, Emergent will fill and complete commercial quantities of Biodel Inc (NASDAQ:BIOD)’s GEM device, to which it holds exclusive rights for use with glucagon. The financial terms for the deal have not been disclosed. GEM is a customized version of Unilife’s dual chamber auto reconstitution syringe. It is being developed to be used to treat severe hypoglycemia and would act as a rescue treatment. It is intuitive and simple device which aims at addressing and expanding the market which is not catered to very efficiently by the currently available kits, which are also difficult to gather and operate in emergency cases.
According to reports, severe hypoglycemia results in the hospitalizations of more than 200,000 people every year. Whereas mild to moderate hypoglycemia result in only headaches and weaknesses, severe hypoglycemia is known to cause loss of consciousness and even seizures. The longer the duration of unconsciousness, the greater is chance of brain damage which may even extend to death in certain cases.
New Drug Application
The “fill and finish” deal, together with the earlier announced license and supply agreement for the GEM device with Unilife and bulk glucagon supply deal with Bachem is aimed at continuing the company’s arrangements for the expected submission of a New Drug Application to the U.S. Food and Drug Administration by next year. It also seeks a consequent commercial introduction of the product.
Biodel Inc (NASDAQ:BIOD)’s President and chief Executive Officer Dr. Errol De Souza said that with this agreement, both the parties would achieve and important milestone. Both concerned are seeking to rapidly move in the direction of commercialization of the first of their two unique glucagon rescue products.
