Both Amylin and Alkermes anxiously await the FDA word that their once weekly diabetes drug, Bydureon, is approved for sale. The drug was developed by Amylin and Eli Lilly and uses Alkermes stabilizing, slow-release technology to keep it active in the bloodstream longer. The FDA is currently assessing the REMS plan that it requested back in March. The agency is targeting the big announcement by October 22nd.
Both Amylin and Alkermes could use the milestone payments and/or royalties triggered by the approval and sale of the drug. Analysts have projected that it could achieve peak annual sales of greater than $2 B per year by 2017. More than 25 million Americans suffer from diabetes and the incidence continues to climb - especially among the obese.
It may be an even more opportune time to introduce Bydureon now as Roche's similar concept taspoglutide product was delayed in filing for approval based on adverse clinical results. This could lead to more of a head start in the market. See Xconomy.