Onglyza in Post-Marketing Study

Recently, Bristol-Myers Squibb (BMY) announced that it has commenced a phase IV (post marketing) study for its type II diabetes drug Onglyza (saxagliptin). Bristol-Myers entered into collaboration with AstraZeneca plc (AZN) in Jan 2007 to research, develop and commercialize select candidates for type II diabetes. 

The post marketing study was partly designed to fulfill the requirement of the U.S. Food and Drug Administration (FDA) in addition to finding out the potential benefit of the drug beyond glucose reduction.
 
The multicenter, randomized, double-blind, placebo-controlled study intends to evaluate the efficacy of the diabetes drug in treating patients who possess the risk of developing cardiovascular diseases. The placebo-controlled study will follow approximately 12,000 patients suffering from type II diabetes (treated with Onglyza) over a five-year period. 

The post marketing study, known as Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR-TIMI 53), aims to find out whether adding Onglyza to a patient’s current standard of care will reduce the risk of cardiovascular death, heart attack or stroke compared to placebo.
 
As a reminder, Onglyza, a dipeptidyl peptidase-4 (DPP IV) inhibitor, contributed approximately $4 million in sales in the most recent quarter (ended Dec 31, 2009). The drug has been submitted to regulatory authorities in more than 50 countries, and is approved in 38 countries and launched in the United States (the FDA approved Onglyza in July 2009), Canada , Mexico , Germany , UK and Denmark . 

Onglyza is used as an adjunct to diet and exercise to improve glycemic control in adults suffering from type II diabetes mellitus. However, the drug should not be used for treating patients with type I diabetes mellitus or diabetic ketoacidosis. Furthermore, the drug has not been studied in combination with insulin. 

Currently, we are Neutral on Bristol-Myers Squibb. The recommendation implies that the stock is expected to perform in line with the overall U.S. equity market over the next six to twelve months. Therefore, we advise investors to retain the stock over this time period.

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