Biodel Inc., a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for diabetes, has signed a long-term manufacturing agreement with Cangene bioPharma Inc., a wholly-owned subsidiary of Emergent BioSolutions (Emergent) for development of  its Glucagon Emergency Management (GEM) programme.

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."

Diabetes patients using insulin commonly experience varying degrees of low blood glucose concentration known as hypoglycemia. Mild to moderate hypoglycemia symptoms such as headache, weakness, or dizziness are generally treated with orally administered carbohydrates, such as orange juice or glucose tablets. Severe hypoglycemia, however, often results in a loss of consciousness or seizures, which typically renders the oral administration of carbohydrates unsafe and requires another person's assistance. In such emergency cases, an injection of glucagon can help rapidly raise the patient's blood glucose concentration. The longer a patient is unconscious due to severe hypoglycemia, the greater the chance of brain damage or death. It is estimated that there are over 200,000 hospitalizations per year due to severe hypoglycemia.

Glucagon is a hormone secreted by the pancreas which opposes the action of insulin by promoting the breakdown of glycogen into glucose in the liver, thereby raising the levels of blood glucose. Glucagon is inherently unstable in a liquid solution and therefore is currently only available as a rescue kit consisting of a vial containing a dry (lyophilized) powder of glucagon and a syringe containing a liquid solution. To administer glucagon with this kit, the liquid solution must first be injected into the vial with the dry powder and mixed. After the glucagon powder has dissolved, it is then drawn back into the syringe and injected into the patient. In order to properly administer the glucagon, a caregiver must be trained to follow this multi-step process in a situation typically made challenging by the patient's condition.

It is widely understood by patients, physicians and Diabetes Educators that the complexity of the currently available rescue kits and the training required for proper administration of glucagon using those kits have resulted in the underuse of glucagon as a rescue treatment for diabetes patients experiencing severe hypoglycemia. It is estimated that only 10% to 20% of high-risk patients currently have an unexpired glucagon kit. Given this low level of market penetration, the current $130 million U.S. market could expand significantly upon the introduction of an easy-to-use presentation. The syringe supplied by Unilife requires three simple, intuitive steps as compared to seven or more steps for the currently available manual reconstitution rescue kits.

Cangene bioPharma, Inc., located in Baltimore, Maryland, caters to a diverse group of partners in the pharmaceutical and biotechnology industries. Cangene bioPharma, Inc. focuses primarily on fill/finishing services for vial and syringe presentations in both liquid and lyophilized forms, and produces both commercial and clinical trial products.