LY2189265 is going to cost a lot more to develop than Bydureon because it has to follow FDA new Guidance for Industry Diabetes Mellitus — Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes while Bydureon didn't.
If they don't care, they shouldn't spend the money. If they think it will clean Bydureon's clock, then shouldn't buy AMLN. Not impressed with LLY's decision making.
SNY’s Lixisenatide Succeeds in Phase-3 As Adjunct to Lantus
[As a GLP-1 drug with qD dosing, Lixisenatide would seem to offer little differentiation as a monotherapy in this already crowded arena. That’s presumably why SNY is testing Lixisenatide as an adjunct to Lantus.]
French drug maker Sanofi-Aventis SA on Thursday reported promising results for a final-stage study on its experimental lixisenatide drug to treat Type 2 diabetes.
Results of the Phase-III clinical trial showed once-daily doses of lixisenatide significantly improved control of blood sugar levels in Asian patients and also presented no safety concerns, Sanofi said in a statement.
The study, called GETGOAL-L Asia, was a 24-week, double-blind, placebo-controlled, parallel-group, multicenter trial that assessed the safety and efficacy of lixisenatide as an add-on therapy in 311 Asian patients with Type 2 diabetes who couldn't control their condition with basal insulin.
Lixisenatide is a so-called GLP-1 drug which could eventually join similar drugs from rivals such as Eli Lilly and Amylin's Byetta and Novo Nordisk's Liraglutide.
Sanofi wants to expand its line of diabetes offerings, which includes blockbuster insulin Lantus, Apidra and Amaryl, and has set up a diabetes division to become more competitive in the fight against the disease, which is exploding world-wide as more people become overweight.‹
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