Biotech Values

[DewDiligence]

Re: Bydureon debacle

…there is no pressing reason to approve Bydureon immediately. There are Byetta, Victoza already on the market. It's not going to be approved unless the question is resolved. As one FDA official said, the 3rd and 4th drug in the same class are tougher to get approved.

The commercial relevance of Bydureon just got even slimmer insofar as Bydureon failed show non-inferiority to NVO’s Victoza in AMLN’s own head-to-head study:

http://finance.yahoo.com/news/DURATION6-TopLine-Study-prnews-1873207569.html?x=0&.v=1

The mean reduction HbA1C was 1.5% for Victoza and 1.3% for Bydureon.