Recently, Bristol-Myers Squibb Company’s (BMY) pipeline received a boost when its type II diabetes candidate, dapagliflozin, fared well in a late-stage multicenter, international, randomized, parallel-group, double-blind, placebo-controlled study (n=597). Dapagliflozin, a once-daily pill, is being co-developed with AstraZeneca Plc (AZN) for treating patients suffering from type II diabetes which is characterized by the dysfunction of beta cells in the pancreas. This results in reduced insulin secretion thereby leading to elevated glucose levels.
Results from the 24 week study, presented at the European Association for the Study of Diabetes (EASD) revealed that a combination of dapagliflozin and glimepiride was more effective in reducing blood sugar levels compared to glimepiride and a placebo. Moreover, the weight reduction was higher in patients treated with the combination of dapagliflozin and glimepiride. Patients receiving dapagliflozin also displayed greater oral glucose tolerance and lower fasting plasma glucose levels after 24 weeks.
The patients enrolled for the study, who were more than or equal to 18 years of age, were equally randomized to one of the four treatment arms – 2.5 mg dapagliflozin plus glimepiride, 5 mg dapagliflozin plus glimepiride, 10 mg dapagliflozin plus glimepiride or placebo plus glimepiride.
It was observed that the rates of adverse events were similar for the treatment groups. However, patients treated with dapagliflozin, which belongs to a family of drugs known as sodium-glucose cotransporter-2 (SGLT2) inhibitors, were more likely to be affected by genital tract infections. SGLT2 inhibitors aid the excretion of glucose and associated calories in urine, thereby lowering the levels of glucose in the blood. Another SGLT2 inhibitor under development is Johnson & Johnson’s (JNJ) canagliflozin.
Lucrative type II diabetes market
We believe that dapagliflozin represents significant commercial potential given the highly lucrative market it will be targeting on approval. The type II diabetes market is highly lucrative with a huge unmet need. According to GlobalData, the type II diabetes market was worth $21.9 billion in 2009 across the globe. This represented a compound annual growth rate of 11.2% between 2001 and 2009.
The prevalence of diabetes in the US and major European countries is on the rise. However, the market is highly competitive and has players like Merck’s (MRK)
Januvia, Amylin’s (AMLN) Byettaand Sanofi’s (SNY) Lantus. The market is getting further crowded with new entrants like Novo Nordisk’s (NVO) Victoza. Moreover, there are a large number of candidates targeting this market in various stages of development.
Currently we have a long-term Neutral stance on Bristol-Myers, which is supported by our Zacks# 3 Rank (short-term ‘Hold’ recommendation) on the stock.
AMYLIN PHARMA (AMLN): Free Stock Analysis Report
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MERCK & CO INC (MRK): Free Stock Analysis Report
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