European Commission approves ONGLYZA as combination therapy with insulin for type 2 diabetes

Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today announced that the European Commission has approved ONGLYZA^® (saxagliptin) for use as a combination therapy with insulin (with or without metformin) to improve blood sugar (glycaemic) control in adult patients with type 2 diabetes.

“The European approval of ONGLYZA as combination therapy with insulin helps to advance treatment of type 2 diabetes, by offering physicians another option to help patients manage this chronic and progressive disease”

The approval was based on Phase 3b 24-week data submitted to the European Medicines Agency which showed that ONGLYZA 5 mg added to insulin (with or without metformin) significantly reduced blood sugar levels (glycosylated hemoglobin levels, or HbA1c) in adult patients with type 2 diabetes, compared to treatment with placebo added to insulin (with or without metformin). In the 28-week extension period of the study, ONGLYZA 5 mg added to insulin (with or without metformin) maintained reductions of HbA1c from 24 to 52 weeks compared to placebo. The proportion of patients who experienced at least one adverse side effect was similar between the two treatment groups.

The data from the 24-week trial were presented at the 71^st American Diabetes Association Scientific Sessions in June 2011 and the data from the 28-week extension period were presented at the 47^th European Association for the Study of Diabetes Annual Meeting in September 2011.

"Since many patients with type 2 diabetes eventually require insulin, it is important that anti-diabetic treatments can be used with insulin to help patients who are inadequately controlled on their current regimen to reach their treatment goals," said Brian Daniels, M.D., senior vice president, Global Development and Medical Affairs, Bristol-Myers Squibb.

"The European approval of ONGLYZA as combination therapy with insulin helps to advance treatment of type 2 diabetes, by offering physicians another option to help patients manage this chronic and progressive disease," said Howard Hutchinson, M.D., chief medical officer, AstraZeneca.

ONGLYZA is indicated in adult patients with type 2 diabetes mellitus to improve glycaemic control in combination with metformin, sulphonylurea, thiazolidinedione or insulin, when each treatment alone, with diet and exercise, does not provide adequate glycaemic control. Sulphonylureas and insulin are known to cause hypoglycaemia. Therefore, a lower dose of sulphonylurea or insulin may be required to reduce the risk of hypoglycaemia when used in combination with ONGLYZA.

ONGLYZA should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. ONGLYZA is not a substitute for insulin in insulin-requiring patients.