Sanofi's combination diabetes drug hits goal in late-stage trial

[July 29, 2015]  PARIS (Reuters) - Sanofi said on Wednesday a first late-stage Phase III study of its LixiLan diabetes drug had met its main target, while another would be completed at the end of the third quarter.

LixiLan consists of a single-injection combination of Lyxumia, a drug developed with Danish drugmaker Zealand Pharma, and Sanofi's Lantus. It targets patients suffering from type 2 diabetes.

The first study tested the efficacy and safety of LixiLan versus treatment with either Lantus or Lyxumia alone. The new drug proved better at reducing average blood glucose levels than either Lantus or Lyxumia.

A second study is investigating LixiLan patients whose type 2 diabetes is not adequately controlled on Lantus alone.

"Full results will be communicated in an appropriate scientific forum," the French drugmaker said in a statement.

"Following an analysis of results from both Phase III studies ... Sanofi will determine the next steps in the regulatory process," Sanofi said. "Currently, regulatory submissions are planned for Q4 2015 in the United States and Q1 2016 in the European Union."

LixiLan sales are expected to reach around $1 billion in 2020, according to consensus forecasts compiled by Thomson Reuters Cortellis. The drug is likely to compete with NovoNordisk's Xultophy.

Nearly 400 million people worldwide have diabetes, with type 2 accounting for more than 90 percent of cases. Without proper treatment or lifestyle changes, those numbers are expected to grow substantially in the coming years.

(Reporting by Matthias Blamont; Editing by James Regan)

[© 2015 Thomson Reuters. All rights reserved.]

Copyright 2015 Reuters. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.