Bristol-Myers Squibb Company (BMY) and partner AstraZeneca (AZN) recently presented data from a late-stage study which evaluated their candidate dapagliflozin in adults suffering from type II diabetes over 48 weeks.
Data from the randomized, parallel-group, double-blind, placebo-controlled study revealed that treatment with the combination of dapagliflozin and glimepiride resulted in similar reduction in blood sugar levels over 48 weeks as was observed over 24 weeks. Results from the 24-week study were presented in 2010.
The study was extended by 24 weeks to evaluate the maintenance of efficacy, as well as safety and tolerability of the combination of dapagliflozin and glimepiride, over 48 weeks, in type II diabetes patients versus placebo and glimepiride.
Patients treated with the combination of dapagliflozin and glimepiride also demonstrated reductions in fasting plasma glucose levels, post-prandial glucose and total body weight over 48 weeks.
We remind investors that dapagliflozin is currently under review both in the EU as well as in the US for the treatment of type II diabetes. Originally, the US Food and Drug Administration (FDA) was scheduled to decide on the fate of dapagliflozin by October 28, 2011 (action date). However, the action date was pushed back to January 28, 2012 since the agency needed more time to review the additional data demanded by it.
We note that dapagliflozin would target a highly lucrative diabetes market on approval. The market offers significant commercial potential. Moreover, the incidence of diabetes is on the rise, thanks to the rise in the aging population and also obesity.
So far in 2011, it is estimated that approximately 365 million people aged between 20 – 79 years have been affected by diabetes across the globe. The affected population is expected to exceed 550 million by 2030. Type II diabetes accounts for bulk of the diabetes cases diagnosed.
However, dapagliflozin would face competition from big players like Merck & Co. (MRK) and Novo Nordisk (NVO). Moreover, other therapies for type II diabetes are under development. Consequently, we prefer to remain on the sidelines with a Neutral view on the stock until dapagliflozin gets approved and starts delivering. The stock carries a Zacks #3 Rank (short-term “Hold” rating) in the short- run.
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