Recently, Bristol-Myers Squibb Company (BMY) and partner AstraZeneca (AZN) presented encouraging data from two late-stage studies which evaluated their type II diabetes candidate dapagliflozin in conjunction with the extended-release version of metformin (XR).
Data from the two 24-week studies, which evaluated adults suffering from type II diabetes, were presented at the American Diabetes Association (ADA) Scientific Sessions.
Data from the studies revealed that there was a significant reduction in blood sugar levels in patients treated with dapagliflozin and metformin XR versus those treated with dapagliflozin or metformin XR alone and placebo. Moreover, no major events related to hypoglycemia were reported in the studies. Hypoglycemia refers to the situation of abnormally low levels of glucose in the blood.
Results also revealed that patients treated with the combination of dapagliflozin and metformin XR demonstrated improved morning blood sugar levels (fasting plasma glucose). Furthermore, these patients lost more weight compared to those treated with dapagliflozin or metformin XR alone.
We note that Bristol-Myers is seeking approval for dapagliflozin in both the US and Europe. A response from the US Food and Drug Administration (FDA) is expected by October 28, 2011. The European Medicines Agency (EMA) validated the Marketing Authorisation Application (MAA) for the candidate in January 2011.
Approval in the US as well as EU would significantly bolster the top line at Bristol-Myers, which is looking to strengthen its product portfolio by launching new drugs to make up for the loss of revenues that is expected due to the impending genericization of key drugs.
Our Recommendation
We currently have a Neutral recommendation on Bristol-Myers in the long-run. The stock carries a Zacks #3 Rank (Hold rating) in the short-run.
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