ABC
1Main
2Brand NameNesina, Vipidia SYR-322
3Generic Namealogliptin
4IndicationType 2 Diabetes
5EconomicsPPDI
6SafetyHave not seen skin toxicity in animals.
7TimelineNDA submitted 1/4/2008. FDA now asking for CV studies, and Takeda is delaying EU filing until 2012.
8CompetitionJanuvia (MRK). $42m. $87m. $144m. $185m. Q1-Q4 of launch.
9BMY, NVS (Galvus).
10Clinical Trials
11Phase 3 trials - 6 conducted
123 deaths in studies--2 unrelated and one possibly related.