Sanofi-Aventis (SNY) recently presented encouraging top-line data on its type II diabetes candidate, lixisenatide (AVE0010), from its GetGoal phase III clinical program. Results showed that treatment with lixisenatide resulted in a significant reduction in HbA1c levels compared to placebo. A higher number of patients achieved less than 7% HbA1c levels and improved glycemic control while being treated with lixisenatide.
Lixisenatide was found to be generally well-tolerated, with nausea being the most common adverse event. Full results from the study will be presented at the annual meeting of the European Association for the Study of Diabetes (EASD) in September 2010.
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 4500 patients.
Sanofi intends to commence a phase III trial that will evaluate the efficacy of a combination treatment of lixisenatide with Lantus later this year. The successful development of lixisenatide would be a major boost for Sanofi’s diabetes care portfolio.
The company has been looking to strengthen its position in the field of diabetes, and recently in-licensed an early stage diabetes candidate from biopharma company, CureDM Group Holdings.
Sanofi’s diabetes portfolio consists of products like Lantus, Apidra and Amaryl. Combined sales from these products exceeded €3.6 billion in 2009. Sanofi has several compounds in development for the treatment of diabetes.
The diabetes market represents significant commercial potential. According to the company, more than 230 million people are afflicted with the disease across the world. The prevalence of diabetes should continue increasing due to factors like sedentary lifestyles, excessive weight and obesity, unhealthy diets and aging populations.
We currently have an Underperform recommendation on Sanofi. Our biggest concern for Sanofi is the high exposure to generic risk on many of its leading franchises. While new product launches should make significant revenue contributions in the early part of the decade, they will not be enough to compensate for increased generic erosion.
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