Eyeguard A (in active setting) data is expected at YE. Eyeguard B (in behcets) data is expected mid-14. Eyeguard C (maintenance setting) data is expected Q1 14.
Servier is reponsible for the first $50M in trial costs after which expenses are split 50/50. Based on discussions with the FDA, the company feels an NDA can be filed with results from any two of the three Ph3 trials. XOMA maintains rights in the US and Japan and fully intends to commercialize Gevokizumab in US. The 150,000 US pts are treated by approximately 170 specialists which lends itself to a very targeted salesforce. While the company did not discuss its pricing/commercialization plans, they intend to price Gevokizumab as a "biologic" (which I assume to mean $$$) and feel that uveitis could be a very large market for Gevokizumab .
The CEO touched on Servier's 21 patient follow-on trial that preceded the Eyeguard B Ph3 trial. While the data has not been published, the results from this trial precipitated Servier's decision to move quickly to Ph3.
So, is Eyeguard B, the trial set to read out last, the lowest hanging fruit of the different Phase 3 trials? If so, unless we are extremely confident of Eyeguard A, which is first to read out, I might be inclined to sit out and wait to play the Eyeguard B results. You know I hate playing Phase 3 results! LOL
Based on discussions with the FDA, the company feels an NDA can be filed with results from any two of the three Ph3 trials.
One more follow-up if I may. Are you saying XOMA has to hit on 2 of the 3 Phase 3 trials for approval? So, positive results in Eyeguard B won't be sufficient for approval if the two prior trials fail beforehand?