The FDA posted its approval of Bydureon to its website today. It's official. Amylin (and Alkermes) will be able to market its once-weekly injectable GLP-1 diabetes medication. It will now move into a closely watched competition with Novo's Victoza (also a GLP-1 drug).
Since the last delay at the FDA in October 2010, Amylin has broken up with its co-marketing partner Eli Lilly and will be on its own in marketing the drug. Lilly received $250 M to dissolve the partnership and will get $150 M with the FDA approval. It will also receive a 15% royalty on sales until a $1.2 billion note has been satisfied. Analysts say that Amylin sales of Bydureon could reach a peak value of $1.8 billion annually by 2018. See Xconomy, Seeking Alpha and Pharmalot.
If at first you don't succeed, try try again.
Posted by Bruce Lehr Jan 27th 2012.