Terms of PFE partnership in NSCLC. $455M of potential milestones, of which about 2/3 are clinical/regulatory and about 1/3 are sales-based. Royalty is double-digit.
Design of phase-3 trials being run by PFE. Each trial tests “676” +/- a standard chemo doublet. Primary endpoint is survival.
NSCLC: These phase-2 results were used to design the ongoing phase-3 trials. 111 patients; primary endpoint of RR doubled from 19% in control arm to 38% in treatment arm (p=0.048); secondary endpoint of overall-survival: HR=0.73 (p=0.17); secondary endpoint of survival at 1 year: HR=0.65 (p=0.10). Kaplan- Meier curve shown below.
This is the lead trial of Actilon for HCV, now enrolling. 90 treatment-refractory patients (60 on Actilon); patients whose viral load drops by >=1.5 logs at 12 weeks will be allowed to continue treatment for additional 36 weeks. 12-week data will be released in 2H06.
Clinical milestones for 2006. The SNY-partnered program in asthma/allergy has been on FDA clinical hold since June, 2005.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”