Sanofi-Aventis (SNY) recently presented positive top-line results on its type II diabetes candidate, lixisenatide (AVE 0010). Results from a phase III study (GetGoal-X) showed that lixisenatide once-daily met its primary efficacy endpoint and demonstrated fewer number of hypoglycemic events compared to Eli Lilly/Amylin’s (LLY/AMLN) Byetta (exenatide twice-daily).
The open-label, active-controlled, two-arm parallel-group, multi-center study was conducted with 639 patients who were randomized to receive either lixisenatide or Byetta. Results showed that a lesser number of patients in the lixisenatide arm reported symptomatic hypoglycemia compared to Byetta (2.5% versus 7.9%). The number of hypoglycemic events was significantly lower in the lixisenatide arm (8 versus 48). Full results will be presented at a medical meeting.
Lixisenatide is a once-daily glucagon-like peptide-1 (GLP-1) agonist, which was found to be effective in lowering blood sugar in a phase IIb study. The candidate was advanced into the GetGoal clinical program in May 2008. This program consists of 9 studies that are being conducted with more than 4,500 patients. Results from the next GetGoal study will be released in the second quarter of 2011.
While the EU filing for lixisenatide is scheduled to take place in the second half of 2011, the US filing is scheduled for the second half of 2012. The successful development of lixisenatide would be a major boost for Sanofi’s diabetes care portfolio.
Sanofi, which has several compounds in development for the treatment of diabetes, has been looking to strengthen its position in the field of diabetes. The diabetes market represents significant commercial potential. Sanofi’s diabetes portfolio consists of products like Lantus, Apidra and Amaryl. Combined sales from these products exceeded €3.6 billion in 2009.
AMYLIN PHARMA (AMLN): Free Stock Analysis Report
LILLY ELI & CO (LLY): Free Stock Analysis Report
SANOFI-AVENTIS (SNY): Free Stock Analysis Report
Zacks Investment Research
