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 proprietary formulation technologies to existing drugs in order to improve their therapeutic profiles. Its 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’ formulations. Its glucagon formulations and presentations are designed to be stable at room temperature and are intended for use by caregivers with no medical training as a rescue treatment for diabetes patients experiencing severe hypoglycemia, or very low concentrations of blood glucose. The company’s ultra-rapid-acting insulin formulation, BIOD-123, combines recombinant human insulin (RHI), with its proprietary combination of excipients to increase the rate of absorption following the injection. The company also uses its proprietary excipients to develop ultra-rapid-acting insulin analog-based formulations using either insulin lispro, the active pharmaceutical ingredient in Humalog, or insulin aspart, the active pharmaceutical ingredient in NovoLog. Development of Ultra-Rapid-Acting Insulin Formulations 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 its Linjeta formulation of RHI to either Humulin R, which is a branded formulation of RHI, or Humalog. Regulations United States Government Regulation: The company intends to seek the U.S. Food and Drug Administration (FDA) approval for its product candidates in a new drug application (NDA), and not under an application submitted for approval as a biologic under the Public Health Service Act. Strategy The company’s strategy is to selectively enter into collaboration agreements with pharmaceutical or biotechnology companies for the commercialization of its product candidates. 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 June 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 entered into an agreement with Aegis Therapeutics, LLC, or Aegis, 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 entered into a customization and commercial supply agreement with Unilife Medical Solutions, Inc., 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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