Sanofi GLP-1 diabetes drug edges Byetta in Phase III study

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Building up its war chest of positive data for the Type 2 diabetes drug lixisenatide, Sanofi-Aventis has hit another primary goal in a late stage study: Non-inferiority to Byetta (exenatide) for glycemic control. In fact, says Zealand Pharma, which licensed the drug to Sanofi, fewer patients taking the experimental therapy suffered hypoglycemic events than the patients in the Byetta arm.

Investigators reported that in the lixisenatide arm of the trial only 2.5 percent of patients reported symptomatic hypoglycemia, compared to 7.9 percent of the people who were on exenatide. Six-fold fewer hypoglycemia events were observed in patients on lixisenatide than those treated with exenatide (8 vs. 48 events)

"GetGoal-X, the first head-to-head study comparing lixisenatide with another GLP-1, demonstrates the efficacy of lixisenatide once-daily in reducing HbA1c in people with type 2 diabetes and also shows a better hypoglycemia profile," said Pierre Chancel, Sanofi's SVP of global diabetes. The promising drug candidate is designed to spur the release of insulin when a diabetic's glucose level climbs too high. If it can make a successful case to regulators, it's being billed as a blockbuster contender to Victoza from Novo Nordisk and Byetta from Eli Lilly and Amylin. It's a booming field, with the number of diabetics in the world expectd to grow from 285 million to 435 million in the next 20 years.

Last spring Jefferies estimated peak sales of lixisenatide at $500 million with a 2012 launch "but see the drug as being a late-comer in what is looking to be a crowded GLP-1 market."

- here's the Zealand release

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