Pipeline

Diabetes is a disease characterized by abnormally high levels of blood glucose and inadequate levels of insulin. Glucose is a simple sugar used by all the cells of the body to produce energy and support life.

Humans need a minimum level of glucose in their blood at all times to function and stay alive. Insulin is a peptide hormone naturally secreted by the pancreas to regulate the body's management of glucose.

When a healthy individual begins a meal, the pancreas releases a natural spike of insulin, called the first-phase insulin release, which is critical to the body's overall control of glucose.

Many patients with diabetes lack the first-phase insulin release and must treat themselves with daily meal-time insulin injections to avoid the negative effects of hyperglycemia and hypoglycemia.

BIOD-Stable Glucagon

Biodel is developing a pH 7 (neutral), clear-liquid, stabilized form of glucagon as a pre-mixed “rescue” drug that can be delivered in an auto-injector device to treat insulin overdoses. Glucagon is a highly unstable compound that helps regulate blood glucose levels by signaling the liver to convert glycogen into glucose.

It is currently sold as an acidic dry powder which must be reconstituted into a liquid by a care-giver for injection into the patient. Biodel plans to seek FDA approval of this compound under section 505(b)2 of the Federal Food, Drug and Cosmetic Act which governs the review of an NDA for a modified form of a previously approved product.

We are also working with physicians at leading U.S. medical centers to develop a more stable form of glucagon for use in bi-hormonal pumps to enable more aggressive treatment of diabetes with insulin. Bi-hormonal pumps are being developed to replace current insulin pumps and continuous glucose monitoring devices and allow for more effective continuous regulation of blood glucose. We are currently conducting preclinical studies to evaluate this exciting new approach to diabetes management.

In March 2012, we announced that we had received feedback from the FDA regarding regulatory requirements for the development of a liquid formulation of glucagon for use as a rescue treatment for diabetes patients experiencing hypoglycemia. Subject to successful completion of clinical trials, we intend to submit an NDA for this product candidate in the fourth calendar quarter of 2013 or the first calendar quarter of 2014.