AMLN Amylin Pharmaceuticals, Inc. (MM)

Sanofi-Aventis (SNY) recently presented positive phase III data on its type II diabetes candidate, Lyxumia (lixisenatide) from the GetGoal-L study. Results from the randomized (double-blind), placebo-controlled study showed that treatment with Lyxumia, when added to basal insulin, resulted in a significant reduction in HbA1c levels compared to placebo.

The reduction in HbA1c levels was achieved without a major increase in the risk of hypoglycemia. Moreover, patients in the Lyxumia arm reported a significant reduction in body weight.

Lyxumia 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 4,300 patients. Sanofi has already reported positive data from the GetGoal-X, GetGoal-Mono, GetGoal-L Asia and GetGoal-S studies and expects to report additional results over the course of the year.

The successful development of Lyxumia would be a major boost for Sanofi’s diabetes care portfolio. While the EU filing for Lyxumia is scheduled to take place in 2011, the US filing is scheduled for 2012. Currently available diabetes treatments include Novo Nordisk’s (NVO) Victoza, Amylin Pharma/Eli Lilly’s (AMLN/LLY) Byetta and Merck’s (MRK) Januvia/Janumet among others.

Sanofi has been looking to strengthen its position in the field of diabetes, which represents significant commercial potential. Sanofi’s diabetes portfolio consists of products like Lantus, Apidra and Amaryl. Combined sales from these products exceeded €4.3 billion in 2010.

Sanofi in-licensed Lyxumia from Zealand Pharma A/S. In addition to the GetGoal studies, Lyxumia is in a phase I study which is evaluating Lyxumia in combination with Lantus.

Neutral on Sanofi

We currently have a Neutral recommendation on Sanofi. The company recently completed its acquisition of biotech company Genzyme Corporation. This acquisition will boost Sanofi’s revenues as well as its pipeline.

 
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