Biotech Values

[DewDiligence]

SNY details Lyxumia-vs-Byetta data from GetGoal-X:

http://finance.yahoo.com/news/Positive-Results-for-prnews-511265329.html?x=0&.v=1

• Lixisenatide once daily achieved its primary endpoint of non-inferiority in A1C reduction versus exenatide twice daily (LS mean +/- SE change from baseline: -0.79 +/- 0.05 vs. -0.96 +/- 0.05).

• Discontinuations due to adverse events (mainly gastrointestinal events including nausea, diarrhea and vomiting) were 33 (10.4%) in the lixisenatide group and 41 (13.0%) in the exenatide group.

• Significantly fewer patients experienced symptomatic hypoglycemia with lixisenatide (2.5% vs. 7.9%, p<0.05), with 6-fold fewer hypoglycemic events (8 vs. 48) versus exenatide.

So far, so good; however, I don’t understand this:

• Mean body weight significantly decreased from baseline in the lixisenatide group compared to the exenatide group (94.5 to 91.7 kg with lixisenatide vs. 96.7 to 92.9 kg with exenatide).

How can that be right?

The success of GetGoal-X on the primary endpoint was reported in Feb 2011 (#msg-59446260), but this weekend was the first time the data were presented.

See the prologue of #msg-63710626 for more info on the Lyxumia phase-3 program.