Ariad Pharmaceuticals Inc fka ARIA

[Moanrch]

BMO Today:
Our View:
1) Durability of ICLUSIG response in the salvage setting, in particular for patients with T315i mutation and few treatment options, is impressive but serious thrombotic and vaso-occlusive events remain a concern.
2) While ARIA has modeled a 40% reduction in thombosis/vaso-occlusive event risk for every 15mg reduction in dose, we would note that ARIA data interpretation has diverged widely from FDA.
3) With focus on prospects for re-introduction of ICLUSIG distribution, ARIA has indicated regular dialogue with FDA but we continue to expect an ODAC panel review before ICLUSIG comes back, and see real risk that additional clinical trial(s) will be required.