- New Drug Application submission anticipated in 2015
- Acquired worldwide exclusivity to proprietary dual-chamber device
DANBURY, Conn., June 6, 2013 (GLOBE NEWSWIRE) -- Biodel Inc. (Nasdaq:BIOD) today announced plans to submit a New Drug Application (NDA) to the FDA in 2015 for a novel glucagon rescue device to treat severe hypoglycemia.
Having previously signed a long-term commercial supply agreement for bulk glucagon, Biodel expects to select a final formulation of its novel glucagon therapy and appoint a contract manufacturing partner during the current calendar quarter. The submission of an Investigational New Drug application to the FDA is expected during the next 12 months. Initiation of a pivotal clinical study is expected to occur during the second half of 2014, putting the Company in a position to file an NDA to the FDA under the 505(b)(2) regulatory pathway in 2015.
In preparation for the anticipated regulatory filing and commercial launch of its glucagon rescue product, Biodel has signed a 15-year supply agreement with Unilife Corporation for a customized proprietary device from its EZMix™ platform of dual-chamber devices with worldwide exclusivity for use with glucagon. The device has been customized for convenient portability and ease of use to enable rapid treatment during emergency situations with little to no training. The device automatically reconstitutes lyophilized glucagon when prepared for injection and features automatic, user-controlled retraction of the needle upon full dose delivery, virtually eliminating dosing errors and the risk of needle stick injuries. [A rendering of the device is available on Biodel's website at www.biodel.com/glucagondevice]
Dr. Errol De Souza, Biodel's president and chief executive officer, stated: "We are pleased with the rapid progress that we have made in identifying a competitive, easy to use and innovative glucagon rescue presentation, which leverages the strengths of room temperature stability and addresses the limitations of currently marketed products. We look forward to providing more detailed timelines as we progress through various 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 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 has 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 $125 million U.S. market could expand significantly upon the introduction of an easy-to-use presentation. The device supplied by Unilife requires three simple, intuitive steps as compared to seven or more steps for the currently available 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. We develop our product candidates by applying our proprietary formulation technologies to existing drugs in order to improve their therapeutic profiles. For more information, please visit www.biodel.com.
About Unilife Corporation
Unilife Corporation (Nasdaq:UNIS) is a U.S. based developer and commercial supplier of proprietary injectable drug delivery systems including EZMix™, which is an innovative and highly differentiated platform of dual-chamber syringes that meet the needs of lyophilized, powder filled or liquid-liquid drug combinations. Proprietary features include orientation-free, ventless mixing to minimize drug loss and maintain sterility until time of injection, and the automatic, user-controlled retraction of the needle upon full dose delivery to virtually eliminate the risk of needlestick injuries. EZMix™ dual-chamber syringes are designed for intuitive use by healthcare workers or patients, with minimal steps required for reconstitution and injection of the therapy. For more information, please visit www.unilife.com.
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 successfully complete a Phase 2 clinical trial of a proprietary insulin formulation in a timely manner, and the outcome of that trial; 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 March 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.
CONTACT: Seth D. Lewis, +1-646-378-2952Source:Biodel Inc.