CHICAGO--Sanofi ($SNY) has provided the first glimpse at Phase III data for new insulin glargine, which is a next-generation version of its top-selling diabetes drug Lantus. Hoping to ease regulators' concerns about the potential side effects of a new diabetes drug, the late-stage trial shows that the next-gen drug could be safer than Lantus in patients with Type 2 diabetes.
In the debut of the study data here at the annual meeting of the American Diabetes Association, Sanofi said that the experimental insulin, dubbed U300, showed equal ability to keep blood sugar levels under control as Lantus, meeting the study's main goal of noninferiority to the marketed drug.
A key secondary endpoint focused on nighttime low blood sugar, or nocturnal hypoglycemia, which can be deadly in severe cases. Sanofi showed positive data on this score, with fewer cases of low blood sugar at night for patients on U300 compared with Lantus. During months three to 6 of the study, 36.1% of patients on U300 compared with 46% on Lantus suffered from nocturnal hypoglycemia, Sanofi said.
"Whatever improvements we can do in any therapy that reduces hypoglycemia is a good thing," said Dr. Robert Cuddihy, Sanofi's vice president and medical diabetes head, in an interview with FierceBiotech. Hypoglycemia is particularly scary for patients when they are asleep, he said, because their symptoms are more difficult to notice.
The Phase III results come from Sanofi's Edition I study, which is the first of four late-stage trials that the company plans to report this year for U300. Also, top-line data from the Edition II study have confirmed the equal blood-sugar control and reduction in nocturnal hypoglycemia seen in the first study in the late-stage program. Sanofi aims to file for U.S. and European approvals of U300 in the first half of 2014.
Sanofi has a lot riding on showing that U300 is an improvement. The French drug giant's major competitors such as Novo Nordisk ($NVO) and Eli Lilly ($LLY) have been advancing their own long-lasting insulin products, including Lilly's own copycat version of Lantus, in late-stage clinical trials. Novo has also talked up the reductions in nighttime hypoglycemia for patients on its long-acting insulin called Tresiba, which is approved in Europe.
Lantus, which generated 2012 sales of €4.96 billion ($6.5 billion), is the most prescribed long-acting insulin on the market. Yet Lantus loses patent exclusivity in February 2015. And U300 gives Sanofi a chance to stay No. 1 in the market. Sanofi caught a break after the FDA denied approval of Novo's Tresiba, seeking additional clinical data that should significantly delay Novo in delivering its rival therapy onto the U.S market.
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