Biodel Announces Completion of Dosing in Phase 2 Clinical Trial of BIOD-123 in Patients With Type 1 Diabetes Top-Line Data Expected in Third Quarter of 2013 DANBURY, Conn., July 11, 2013 (GLOBE NEWSWIRE) -- Biodel Inc. (Nasdaq:BIOD) today announced that all scheduled follow-up visits have been completed for patients enrolled in the Phase 2 clinical trial of BIOD-123, an investigational ultra-rapid-acting injectable mealtime insulin therapy. Dr. Errol De Souza, president and chief executive officer of Biodel, stated: "Completing the BIOD-123 Phase 2 clinical trial is another significant milestone in the development of novel ultra-rapid-acting mealtime insulins to aid patients and healthcare professionals in the treatment of diabetes. We look forward to sharing the top-line results by the end of this quarter." Study Design The Phase 2 clinical trial of BIOD-123 is a randomized, open label, parallel group study conducted at 33 investigative centers in the United States. In the trial, 132 patients with type 1 diabetes were randomized to receive either BIOD-123 or Humalog^® to use as their mealtime insulin during an 18 week treatment period. Both arms of the study used insulin glargine, sold as Lantus^®, as the basal insulin. The clinical trial is designed to evaluate HbA1c control as the primary endpoint, and secondary endpoints include postprandial glucose excursions, glycemic variability, hypoglycemic event rates and weight changes. About BIOD-123 BIOD-123 is a proprietary formulation of injectable recombinant human insulin with EDTA, citrate and magnesium sulfate. It is designed to be more rapid-acting than mealtime insulin analogs currently used to treat patients with type 1 and type 2 diabetes. In earlier-stage clinical trials, BIOD-123 has been shown to be more rapidly absorbed following subcutaneous administration and have comparable injection site tolerability relative to the rapid-acting insulin analog marketed as Humalog^®. Administered at the start of a meal, the time to peak insulin levels achieved by BIOD-123 more closely mimics the first-phase mealtime insulin release observed in healthy individuals. Since its inception in 2006, Biodel's ultra-rapid-acting insulin program has involved 20 clinical studies and more than 1,000 patients with diabetes. About Diabetes Diabetes is a group of diseases characterized by high blood glucose levels that result from defects in the body's ability to produce and/or use insulin. Humans need a minimum level of glucose in their blood at all times to function and stay alive. Insulin is a peptide hormone naturally secreted by the pancreas to regulate the body's management of glucose. When a healthy individual begins a meal, the pancreas' rapid release of insulin, known as first-phase insulin release, is critical to the body's overall control of glucose. Many patients with diabetes lack first-phase insulin release and must treat themselves with daily meal-time insulin injections to avoid the negative effects of hyperglycemia. About Biodel 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 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. BIOD-G CONTACT: Seth D. Lewis, +1-646-378-2952
Biodel Announces Completion of Dosing in Phase 2 Clinical Trial of BIOD-123 in Patients With Type 1 Diabetes
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