Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today announced that their marketing authorization application for ONGLYZA™ (saxagliptin) received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for the treatment of type 2 diabetes in adults as add-on therapy with metformin, a thiazolidinedione or a sulphonylurea.

The positive opinion was reached after the CHMP reviewed data from a comprehensive clinical development program that included six core Phase III trials assessing the safety and efficacy of saxagliptin as a once-daily therapy. These involved 4,148 patients with type 2 diabetes, including 3,021 patients treated with saxagliptin.

Saxagliptin belongs to the class of dipeptidyl peptidase-4 (DPP-4) inhibitors. These are designed to enhance the body's ability to decrease blood sugar (glucose) when it is elevated by acting on the natural hormones, incretins, thereby increasing insulin production, and by reducing the liver's production of glucose.

This application to the CHMP is for use as a once-daily 5mg dose in adult patients with type 2 diabetes mellitus to improve glycemic control:

• in combination with metformin, when metformin alone, with diet and exercise, does not provide adequate glycemic control;
• in combination with a sulphonylurea, when the sulphonylurea alone, with diet and exercise, does not provide adequate glycemic control in patients for whom use of metformin is considered inappropriate; or
• in combination with a thiazolidinedione, when the thiazolidinedione alone, with diet and exercise, does not provide adequate glycemic control in patients for whom use of a thiazolidinedione is considered appropriate.

The CHMP's positive opinion on ONGLYZA will now be reviewed by the European Commission which has the authority to approve medicines for the European Union. Bristol-Myers Squibb and AstraZeneca expect the European Commission to issue its decision on a Marketing Authorization for this type 2 diabetes investigational drug in the European Union in the coming months.

About DPP-4 Inhibitors

DPP-4 inhibitors are a class of compounds that work by affecting the action of natural hormones in the body called incretins. Incretins decrease elevated blood sugar levels (glucose) by increasing the body's utilization of sugar, mainly through increasing insulin production in the pancreas and decreasing glucagon secretion.

About Type 2 Diabetes

Diabetes (diabetes mellitus) is a chronic disease in which the body does not produce or properly use insulin. Insulin is a hormone that is needed to convert sugar, starches (carbohydrates) and other nutrients into energy needed for daily life. The cause of diabetes continues to be investigated, and both genetic and environmental factors such as obesity and lack of exercise appear to play a role. Diabetes is associated with long-term complications that affect almost every part of the body.