Biodel Inc was incorporated in the State of Delaware on December 3, 2003 and commenced operations in January 2004. The Company is a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for diabetes that might be safer, more effective and more convenient for patients. The Company develops its product candidates by applying proprietary formulation technologies to existing drugs in order to improve their therapeutic profiles. Its most advanced program involves developing proprietary formulations of injectable recombinant human insulin, or RHI, designed to be more rapid-acting than the 'rapid-acting' mealtime insulin analogs currently used to treat patients with Type 1 and Type 2 diabetes. In addition to its ultra-rapid-acting insulin formulation program, the Company is developing a liquid glucagon formulation for use as a rescue treatment for diabetes patients experiencing severe hypoglycemia, or very low concentrations of blood glucose. Potential competitors also include academic institutions, government agencies and other public and private research organizations that conduct research, seek patent protection and establish collaborative arrangements for research, development, manufacturing and commercialization. The FDA and other federal, state, local and foreign regulatory agencies impose substantial requirements upon the clinical development, approval, labeling, manufacture, marketing and distribution of drug products.