Lilly's John Lechleiter, somewhat under duress due to a series of late stage failures in Lilly's pipeline, has been publicly bullish on the chances of Amyvid receiving FDA approval as a diagnostic for Alzheimer's disease. Oops!
The FDA expert committee begs to differ -- at least for now. Lilly was told by the committee to establish a training program to ensure reader accuracy and consistency of interpretation with the test. Lilly apparently has been aware of the training needs and is working on it. However, while this doesn't represent a another pipeline failure per se -- it does represent a delayed approval and a delay in much-needed revenue generation from this product.
Lilly has an agreement to pay up to $800 M to Avid as the diagnostic test meets certain milestones -- including a $300 M upfront. It's tough to earn any of that $300 M back if you aren't on the market. See Fierce Biotech.
Posted by Bruce Lehr March 18th 2011.