Pressure Mounts For Amylin As Bydureon PDUFA Approaches
This article was originally published in The Pink Sheet Daily
With declining sales of Byetta, Amylin has staked its near-term future on the performance of Bydureon, a long-acting formulation of the active ingredient in Byetta.
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Sponsor of the leading GLP-1 agonist, Victoza, sees the launch of the long-acting competitor from Amylin as having a class-wide impact, drawing more patients to GLP-1s – and it thinks that it can stave off the once-weekly contender.
With the unwinding of its once-lucrative nine-year partnership with Eli Lilly, Amylin Pharmaceuticals now carries all the risk – and all the reward – of its exenatide franchise for diabetes. With sole ownership of its exenatide franchise, Amlyin now has the freedom to seek a lucrative partnership or opt to sell the company outright to a large pharma seeking an edge in a growing diabetes market.
Extensive data on immediate and extended release exenatide can be "leveraged and applied" to speed development of a once-monthly injectable, which is ready for Phase III.