Biodel Inc., a development stage company, 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. Its glucagon formulations and presentations are designed to be stable at room temperature and are intended for use by caregivers with little to no medical training as a rescue treatment for diabetes patients experiencing severe hypoglycemia. 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 refers to these as ultra-rapid-acting insulin formulations. The company’s primary product candidate is a glucagon emergency management (GEM), device 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. (Unilife). In 2014, the company submitted an Investigational New Drug application (IND), to the U.S. Food and Drug Administration (FDA), for its GEM product candidate. It has initiated 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, in the fourth calendar quarter of 2014. In addition to its GEM product candidate, the company is developing ultra-rapid-acting proprietary insulin formulations that are designed to be more rapid-acting than the formulations available to Type 1 and Type 2 diabetes patients. BIOD-123, which was evaluated in a Phase 2 clinical trial, combines recombinant human insulin (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, NovoLog, marketed by Novo Nordisk, and Apidra, marketed by Sanofi. Similarly, the company developed BIOD-531, a concentrated ultra-rapid-acting insulin formulation. BIOD-531 contains 400 units of RHI per milliliter (instead of the standard 100 units per milliliter), and, like BIOD-123, is formulated with ethylenediaminetetraacetic acid, citrate and magnesium sulfate. In addition to its RHI-based ultra-rapid-acting insulin formulations, the company is using its proprietary excipients to develop 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. Development of a Glucagon Rescue Product The company’s proprietary ultra-rapid-acting insulin formulations are designed to be absorbed into the blood faster than the rapid-acting insulin analogs. One of the main features of its formulation technology is that it allows the RHI or insulin analog to disassociate, or separate, from the six molecule, or hexameric, form to the single molecule, or monomeric, form and inhibits re-association to the hexameric form. Clinical Trials of Linjeta The company has conducted Phase 1, Phase 2 and Phase 3 clinical trials comparing the performance of itsultra-rapid-acting insulin formulations to marketed insulins. Intellectual Property In 2007, the United States Patent and Trademark Office issued U.S. Patent No. 7,279,457 encompassing its ultra-rapid-acting insulin formulations. The patent would expire no earlier than January 2026. In addition, a related European Patent, EP 1 740 154, was granted in 2009 and expires in March 2025 in the designated countries. Two additional European applications on this technology, EP2 319 500 and EP2 106 790, have been allowed. Related applications have been granted in Australia, Canada and Japan. Additional applications with claims directed to formulations containing insulin, insulin derivatives or analogs are pending in the U.S. and foreign patent offices. The company has an agreement with Aegis Therapeutics, LLC to acquire an exclusive, sublicensable, worldwide license to the protein stabilization technology that the company is using in the development of its liquid glucagon formulations. The company has a customization and commercial supply agreement with Unilife, a wholly owned subsidiary of Unilife Corporation, to acquire an exclusive, sublicensable, worldwide license to a proprietary device platform of dual-chamber devices for use with glucagon. 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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