Biodel Announces Commercial Supply Agreement With BD for Liquid Glucagon Rescue Device
Biodel Inc. (MM) (NASDAQ:BIOD)
Intraday Stock Chart
Heute : Dienstag 17 Dezember 2013
Biodel Inc. (Nasdaq:BIOD) today announced a long-term supply agreement with BD (Becton, Dickinson and Company), a leading global medical technology company, for worldwide exclusive rights to the novel and proprietary BD Uniject SCF? Disposable Auto-Disable Injection System for the delivery of liquid glucagon to treat severe hypoglycemia. Financial terms of the agreement have not been disclosed.
The BD Uniject SCF? Disposable Auto-Disable Injection System is a small, ultra-portable, all-in-one prefilled drug delivery system for intramuscular and subcutaneous injections. Low unit costs allow Biodel to develop liquid glucagon filled multipacks that enable users to remove a single device from refrigerated storage every four months to be carried as a go-anywhere, ultra-portable defense against the threat of severe hypoglycemia. The multipack approach lowers the duration of room temperature stability required for a convenient, portable rescue product and allows users who suffer frequent hypoglycemic events to avoid the need to refill a prescription immediately after using one of the devices. The ultra-portability and simplicity of the BD Uniject SCF? Disposable Auto-Disable Injection System may be particularly compelling to active people with diabetes and parents of children with diabetes. [A rendering of the device is available on Biodel's website at www.biodel.com/uniject.]
Dr. Errol De Souza, Biodel's president and chief executive officer, stated: "We are pleased to achieve another important milestone in our endeavor to redefine the glucose rescue treatment standard. Adding the BD Uniject SCF? Disposable Auto-Disable Injection System to our existing pipeline of adult and pediatric auto-reconstitution devices will enable us to offer a portfolio of devices to address and expand the underserved glucagon rescue treatment market by replacing antiquated, difficult, and cumbersome multi-part kits with simple, convenient, portable therapies that are close at hand when most urgently needed."
Biodel will develop the BD Uniject SCF? Disposable Auto-Disable Injection System as a follow-on product to complement its auto-reconstitution devices, for which an NDA submission is anticipated in 2015. Biodel's auto-reconstitution devices are designed to offer two-year stability for emergency glucagon administration with little to no training. The auto-reconstitution devices automatically reconstitute lyophilized glucagon and feature automatic needle retraction upon full dose delivery, minimizing dosing errors and the risk of needle stick injuries. These features should make the auto-reconstitution devices compelling products for institutions, emergency responders, and many diabetes patients.
Biodel's portfolio of rescue devices should expand the overall glucagon rescue market to a greater degree than a single product offering. Biodel is also developing a pumpable liquid glucagon formulation for future use in an artificial pancreas system.
About BD Uniject SCF? Disposable Auto-Disable Injection System
The BD Uniject SCF? Disposable Auto-Disable Injection System was developed in the early 1980s with support from the U.S. Agency for International Development to address the need for a low-cost vaccine delivery platform in developing countries. The design uses a plastic blister filled with the appropriate dose of medication for one injection. The device should require little training and will be packaged and labeled in a manner so that a non-healthcare professional caregiver can easily administer a dose in an emergency. The user simply pushes in the cap to activate it, inserts the needle, and squeezes the blister. The BD Uniject SCF? Disposable Auto-Disable Injection System has been used in numerous vaccination campaigns in Africa, Asia, and Indonesia.
About Severe Hypoglycemia & Glucagon Rescue
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 less than 10% 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 BD Uniject SCF? Disposable Auto-Disable Injection System 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. 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.
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 June 30, 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.
BIOD-G
CONTACT: John Graziano, +1 (646) 378 2942
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