Date: Mar 05, 2014 Author: press release Source: GlobeNewswire (
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DANBURY, Conn., March 5, 2014 (GLOBE NEWSWIRE) -- 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."
About Severe Hypoglycemia & Glucagon Rescue Therapy
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.
About Biodel Inc.
Biodel Inc. is a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for diabetes that may be safer, more effective and more convenient for patients. Biodel's product candidates are developed by applying proprietary technologies to existing drugs in order to improve their therapeutic profiles. More information about Biodel is available at www.biodel.com.
About Cangene bioPharma, Inc. d/b/a Emergent BioSolutions
Cangene bioPharma, Inc., d/b/a Emergent BioSolutions, has a proven track record as a world-class provider of commercial contract-manufacturing services. A wholly-owned subsidiary of Emergent BioSolutions, Inc., Cangene bioPharma, Inc., located in Baltimore, MD, 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. Cangene bioPharma, Inc.'s regulatory history, proven flexibility, and commitment to quality and continuous improvement make it an excellent choice for pharmaceutical or biotechnology companies looking for value and reliable results through outsourcing. More information about Cangene bioPharma, Inc. is available at www.emergentcontractmanufacturing.com.
Safe-Harbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements about future activities related to the clinical development plans for the company's drug candidates, including the potential timing, design and outcomes of clinical trials; and the company's ability to develop and commercialize product candidates. Forward-looking statements represent our management's judgment regarding future events. All statements, other than statements of historical facts, including statements regarding our strategy, future operations, future clinical trial results, future financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking statements. The words "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The company's forward-looking statements are subject to a number of known and unknown risks and uncertainties that could cause actual results, performance or achievements to differ materially from those described or implied in the forward-looking statements, including, but not limited to, the success of our product candidates, particularly our proprietary formulations of injectable insulin that are designed to be absorbed more rapidly than the "rapid-acting" mealtime insulin analogs presently used to treat patients with type 1 and type 2 diabetes and our glucagon presentation that is intended to treat patients experiencing severe hypoglycemia; our ability to conduct pivotal clinical trials, other tests or analyses required by the U.S. Food and Drug Administration, or FDA, to secure approval to commercialize a proprietary formulation of injectable insulin or a stable glucagon presentation; the success of our formulation development work with insulin analog-based formulations of a proprietary injectable insulin and a stable glucagon presentation; our ability to secure approval from the FDA for our product candidates under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act; the progress, timing or success of our research, development and clinical programs, including any resulting data analyses; our ability to develop and commercialize a proprietary formulation of injectable insulin that may be associated with less injection site discomfort than Linjeta™ (formerly referred to as VIAject®), which is the subject of a complete response letter we received from the FDA; our ability to enter into collaboration arrangements for the commercialization of our product candidates and the success or failure of any such collaborations into which we enter, or our ability to commercialize our product candidates ourselves; our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others; the degree of clinical utility of our product candidates; the ability of our major suppliers to produce our products in our final dosage form; our commercialization, marketing and manufacturing capabilities and strategies; our ability to accurately estimate anticipated operating losses, future revenues, capital requirements and our needs for additional financing; and other factors identified in our most recent report on Form 10-Q for the quarter ended December 31, 2013. The company disclaims any obligation to update any forward-looking statements as a result of events occurring after the date of this press release.
