Biodel Inc. operates as a specialty biopharmaceutical company. The company focuses on the development and commercialization of treatments for diabetes that may be safer for patients. The company develops its product candidates by applying its formulation technologies to existing drugs to improve their therapeutic profiles. The company’s proprietary insulin formulations are designed to be more rapid-acting than the formulations available to Type 1 and Type 2 diabetes patients. The company’s primary glucagon product candidate is a glucagon emergency management (GEM), drug-device combination that is intended to treat diabetes patients experiencing severe hypoglycemia, or very low concentrations of blood glucose. GEM consists of lyophilized glucagon and an aqueous diluent in a proprietary injection device from Unilife Medical Solutions, Inc. The GEM device is a dual-chamber design that automatically reconstitutes lyophilized glucagon immediately prior to injection and features automatic needle retraction on full dose delivery. In 2014, the company submitted an Investigational New Drug application, to the U.S. Food and Drug Administration, for its GEM product candidate. The company completed a Phase 1 clinical trial to assess the pharmacokinetic and pharmacodynamic profiles of BIOD-961, the reconstituted glucagon formulation intended for use in the GEM device. BIOD-961 is the company’s reconstituted formulation of glucagon intended for use in the GEM device. The company’s design in formulating BIOD-961 was to make it comparable to the glucagon formulations used in the marketed rescue kits. The company is developing ultra-rapid-acting proprietary insulin formulations that are designed to be rapid-acting than the formulations available to Type 1 and Type 2 diabetes patients. In addition to its regular human insulin (RHI) based ultra-rapid-acting insulin formulations, the company has used its proprietary excipients to develop pre-clinical analog-based ultra-rapid-acting insulin formulations using either insulin lispro, the active pharmaceutical ingredient in Humalog, or insulin aspart, the active pharmaceutical ingredient in NovoLog. The company is assessing various formulations of liquid glucagon in preclinical studies that it intends for use with Becton Dickinson and the company's Uniject disposable injection system. The company’s proprietary ultra-rapid-acting insulin formulations are designed to be absorbed into the blood faster than the marketed rapid-acting insulin analogs. The company conducted Phase 1, Phase 2 and Phase 3 clinical trials comparing the performance of its ultra-rapid-acting insulin formulations to marketed insulins. BIOD-531, a concentrated ultra-rapid-acting insulin formulation, combines RHI, with the company’s proprietary combination of excipients to increase the rate of absorption following subcutaneous injection when compared to other commercially available insulin formulations, including rapid-acting mealtime insulin analogs, such as Humalog, marketed by Eli Lilly and Company, NovoLog, marketed by Novo Nordisk, and Apidra, marketed by Sanofi. BIOD-531 contains 400 units of RHI per milliliter (instead of the standard 100 units per milliliter), and is formulated with EDTA, citrate and magnesium sulfate. In addition to BIOD-531, the company has developed pre-clinical ultra-rapid-acting insulin formulations using its proprietary excipients in combination with either insulin lispro, the active pharmaceutical ingredient in Humalog, or insulin aspart, the active pharmaceutical ingredient in NovoLog. Strategy The company’s strategy is to selectively enter into collaboration agreements with leading pharmaceutical or biotechnology companies for the commercialization of its product candidates. Intellectual Property and Proprietary Technology In 2007 the United States Patent and Trademark Office issued U.S. Patent No. 7,279,457 encompassing the company’s ultra-rapid-acting insulin formulations. If all maintenance fees are paid, the patent would expire no earlier than January 2026. In addition, a related European Patent, EP 1 740 154, was granted in June 2009 and expires in March 2025 in the designated countries if all annuity fees are paid. Two additional European applications on this technology, EP2 319 500 and EP2 106 790, have been issued and, in 2014, were defended in a third party opposition before the Opposition Division of the European Patent Office. History Biodel Inc. was founded in 2003. The company was incorporated in the state of Delaware in 2003.
biodel inc (BIOD:NASDAQ CM)
100 Saw Mill Road
Danbury, CT 06810
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