Biodel Inc. (BIOD) was a specialty pharmaceutical company focused on the development and commercialization of innovative treatments for diabetes. The company was based in Danbury, Connecticut, and was founded in 2003.
Biodel's lead product candidate was called VIAject, an ultra-rapid-acting insulin formulation designed to improve glycemic control in patients with diabetes. VIAject was intended to provide more rapid and effective control of blood sugar levels than existing insulin products. Biodel had completed Phase 3 clinical trials for VIAject and had submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in 2010.
In addition to VIAject, Biodel also had other insulin formulations in development, including an ultra-rapid-acting glucagon and a concentrated rapid-acting insulin.
However, in 2014, Biodel announced that the FDA had issued a complete response letter (CRL) for the NDA for VIAject. The CRL cited concerns with the manufacturing process and requested additional data related to stability and drug product specifications. Biodel decided not to pursue further development of VIAject and discontinued the program.
Following the discontinuation of VIAject, Biodel shifted its focus to developing concentrated versions of existing insulin products, such as Humalog and NovoLog. However, the company struggled financially and was ultimately acquired by Albireo Pharma in 2016.
Overall, while Biodel had promising potential with VIAject, its inability to obtain FDA approval led to its downfall, and the company was unable to recover.
|
