ABC
1Main
2Brand NameByetta
3Generic Nameexenatide
4EconomicsProfit-share with Amylin. Ex-US royalties to Amylin.
5CompetitionInsulin (+ does not require glucose monitoring and provides weight loss)
6ManufacturingManufacturing straightford, product is just an amino acid sequence and not a biologic. Efficacy achieved with microgram dosing
7Administrationcurrent pen device to deliver either 5mg or 10mg twice a day for 30 months --figure out how painful/large this pen device is.
8Clinical Trials
9recently announced lt-data continued positive data at 82 weeks
10positive data on restoration of First-Phase insulin response (unclear whether this can get added to the label)
11
12
13
14Phase III LAR formulation n=300
15LLY maintains this trial is enough to garner approval--LLY comments to Cowen 2008