Biodel Advances Ultra-Rapid-Acting Concentrated Insulin Formulation Into Clinical Development Top Line Data Expected in First Quarter of 2014 DANBURY, Conn., Nov. 7, 2013 (GLOBE NEWSWIRE) -- Biodel Inc. (Nasdaq:BIOD) today announced the initiation of a Phase 1 clinical trial under its existing U.S. Investigational New Drug Application, as part of the development program for concentrated insulin candidate BIOD-531. BIOD-531 is a proprietary novel formulation of concentrated recombinant human insulin (RHI) with a unique time-action profile to address the growing population of severely insulin resistant type 2 diabetes patients and the existing population of patients currently using premixed insulins to manage both prandial and basal glucose control requirements with a single injection. The company anticipates top line data in the first calendar quarter of 2014. Chief executive officer Dr. Errol De Souza said: "BIOD-531's ultra-rapid-acting onset and basal duration profile, coupled with its high concentration, could offer diabetes patients and medical practitioners a novel tool to improve prandial coverage, while maintaining adequate basal coverage, in both insulin resistant patients and patients who use premixed insulins." Study Design The Study is a four-way cross-over Phase 1 clinical trial in which the pharmacokinetic, pharmacodynamic and injection site toleration profiles of BIOD-531 will be evaluated and compared to Humulin^® R, U-500 and to Humalog^® prandial/basal premixed insulin. Twelve volunteers will receive single injections of each insulin on separate days in a randomized treatment sequence. The identity of each study drug will be blinded at the time of the injection. After each test injection, volunteers will undergo euglycemic clamp studies to determine the pharmacodynamic profile of the test insulin formulation. On two of the test days, BIOD-531 and Humulin R, U-500 will be administered at doses of 1.0 unit/kg, which is the range used by patients with type 2 diabetes and severe insulin resistance. On the other two days of the 4 period Study, BIOD-531 and Humalog 75/25 premixed insulin will be administered at a dose of 0.5 units/kg. This dose reflects that which might be used by patients with moderate degrees of insulin resistance who use premixes. About BIOD-531 Biodel's concentrated insulin candidate BIOD-531 contains 400 units per milliliter (U-400) of RHI formulated with EDTA, citrate and magnesium sulfate. In preclinical studies in diabetic swine, BIOD-531 demonstrated a more rapid rate of absorption and onset of action than RHI Humulin^® R, U-500 and Humalog^® premixed formulations and had a comparable duration of action as RHI Humulin^® R U-500. Based on this unique combination of rapid absorption with a basal duration profile, BIOD-531 may provide superior meal-time glucose control for patients using Humulin^® R, U-500. For patients using premixed prandial/basal insulins, BIOD-531 could enable patients to minimize injection volume while benefitting from the ultra-rapid onset of action. The current unmet medical need for a concentrated ultra-rapid-acting insulin formulation exists among a subset of type 2 diabetes patients who demonstrate severe insulin resistance and require greater than 200 units of insulin daily to meet their insulin needs. Currently Eli Lilly's Humulin^® R, U-500 is the only concentrated RHI product on the U.S. market. Humulin^® R, U-500 concentrated insulin has a suboptimal pharmacokinetic and pharmacodynamic profile with a more prolonged onset than U-100 insulin analog formulations. Eli Lilly and Novo Nordisk market preparations of human insulin or rapid-acting analog prandial insulins premixed with intermediate-acting basal neutral protamine insulins in a variety of ratios such as 70/30, 75/25 and 50/50. Premixes provide basal and bolus therapy with fewer injections per day. Premixes represent approximately thirty percent of the more than $8 billion global rapid-acting prandial insulin market. 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'sproduct candidates are developed by applying proprietary technologies to existing drugs in order to improve their therapeutic profiles. More information aboutBiodelis available atwww.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 theU.S. Food and Drug Administration, orFDA, 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 theFDAfor 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 theFDA; 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 endedJune 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: Seth D. Lewis +1-646-378-2952
Biodel Advances Ultra-Rapid-Acting Concentrated Insulin Formulation Into Clinical Development
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