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Main | | |
| Brand Name | Byetta |
| Generic Name | exenatide |
| Economics | Profit-share with Amylin. Ex-US royalties to Amylin. |
| Competition | Insulin (+ does not require glucose monitoring and provides weight loss) |
| Manufacturing | Manufacturing straightford, product is just an amino acid sequence and not a biologic. Efficacy achieved with microgram dosing |
| Administration | current pen device to deliver either 5mg or 10mg twice a day for 30 months --figure out how painful/large this pen device is. |
| Clinical Trials | |
| | recently announced lt-data continued positive data at 82 weeks |
| | positive data on restoration of First-Phase insulin response (unclear whether this can get added to the label) |
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| | Phase III LAR formulation n=300 |
| | LLY maintains this trial is enough to garner approval--LLY comments to Cowen 2008 |