Biotech Values

[DewDiligence]

AMGN’s D-mab data reported today in the “mixed cancer” trial are additional color on the top-line results announced in August. From #msg-40166756:

The phase-3 denosumab trial in miscellaneous (non-breast, non-prostate) cancer showed statsig non-inferiority to Zometa; however, unlike the phase-3 trial in breast cancer (#msg-39343263), D-mab missed showing statsig superiority to Zometa by a whisker (p=0.06). The hazard ratio for the primary endpoint (time to first skeletal event) was 0.84 in the miscellaneous-cancer trial and 0.82 in the breast trial. (The phase-3 trial of D-mab vs Zometa in HRPC is in progress with data on the primary endpoint expected in 1Q10.)

…All told, the miscellaneous-cancer trial is a strong result for AMGN, although NVS dodged a bullet by the trial’s failure to show statsig superiority for D-mab.

Denosumab has the tentative brand name, Prolia; the PDUFA date for the lead indication in osteoporosis is 10/19/09. #msg-39386685 is a good read on the marketing task that confronts AMGN, assuming FDA approval.