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.

VIAject®

VIAject® is a proprietary more-rapid-acting injectable regular human insulin under development for meal-time use by people with Type 1 or Type 2 diabetes to improve glycemic control.

It is a proprietary form of regular human insulin which was developed to enable more effective blood-glucose control than currently marketed insulin products. Biodel has submitted a New Drug Application to the FDA for approval to market VIAject® as a treatment for Type 1 and Type 2 diabetes, based upon results from pharmacokinetic, pharmacodynamic and standardized meal studies, two pivotal 6-month Phase 3 clinical trials of VIAject® in patients with Type 1 and Type 2 diabetes, as well as interim results from the long-term, 18-month safety extension trials for patients who completed the pivotal Phase 3 clinical trials.

These studies were submitted in our New Drug Application to document the safety and efficacy of VIAject® and show that patients receiving VIAject® had faster reductions in blood-glucose activity, reduced risks of hyperglycemia and hypoglycemia and less weight gain than patients who received recombinant human insulin. Based upon these findings, we believe that VIAject® may offer important clinical benefits to people with diabetes.

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.

VIAject®

VIAject® is a proprietary more-rapid-acting injectable regular human insulin under development for meal-time use by people with Type 1 or Type 2 diabetes to improve glycemic control.

Phase 1 Pharmacokinetic Profile

Phase 2 Meal Study in Type 1 Patients
Hypoglycemia Prevention: Glucose Infused 180-480 min

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.

VIAject®

VIAject® is a proprietary more-rapid-acting injectable regular human insulin under development for meal-time use by people with Type 1 or Type 2 diabetes to improve glycemic control.

Phase 1 Pharmacokinetic Profile

Phase 2 Meal Study in Type 1 Patients Hypoglycemia Prevention: Glucose Infused 180-480 min

Phase 2 Meal Study in Type 1 Patients
Hypoglycemia Prevention: Glucose Infused 180-480 min