ONGLYZA® (saxagliptin) approved for use in Europe as combination therapy with insulin in adults with 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 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 71st American Diabetes Association Scientific Sessions in June 2011 and the data from the 28-week extension period were presented at the 47th 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.

About ONGLYZA® (saxagliptin)

As of September 2011, ONGLYZA has been submitted for regulatory review in more than 90 countries and is approved in 68 countries, including the United States, Canada, Mexico, 30 European countries, India, Brazil and China.

In Europe, ONGLYZA is indicated in adult patients aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control:

• in combination with metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control;
• in combination with a sulphonylurea, when sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate;
• in combination with a thiazolidinedione, when the thiazolidinedione alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of a thiazolidinedione is considered appropriate; or,
• in combination with insulin (with or without metformin), when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.

Please see the Summary of Product Characteristics for the full prescribing information.

About Type 2 Diabetes

By the end of 2011, diabetes is estimated to affect nearly 53 million people aged 20-79 in Europe, and this figure is projected to rise to more than 64 million by 2030. Type 2 diabetes accounts for approximately 90 to 95% of all cases of diagnosed diabetes in adults. Type 2 diabetes is a chronic, progressive disease characterised by insulin resistance and/or dysfunction of beta cells in the pancreas, which decreases insulin sensitivity and secretion, leading to elevated blood glucose levels. Over time, this sustained hyperglycaemia contributes to worsening insulin resistance and further beta cell dysfunction. Significant unmet needs exist as nearly half of treated patients remain uncontrolled on their current glucose-lowering regimen.

Bristol-Myers Squibb and AstraZeneca Collaboration

Bristol-Myers Squibb and AstraZeneca entered into a collaboration in January 2007 to enable the companies to research, develop and commercialise select investigational drugs for type 2 diabetes. The Bristol-Myers Squibb/AstraZeneca Diabetes collaboration is dedicated to global patient care, improving patient outcomes and creating a new vision for the treatment of type 2 diabetes.