- Exelixis will miss trial enrollment timelines, especially since on top of Zytiga, Amgen's(AMGN) Xgeva and Dendreon's(DNDN) Provenge (all approved and competing for prostate cancer patients), Algeta's Alpharadin and MDV3100 will be approved soon and also have compassionate-use programs in place.
- The trials are mis-modeled; the assumptions for survival in the control arm of study 307 are too low. This will make timing of events (deaths) slower and hamper cabo's ability to beat the control arm (survival benefit) by 30%.
- Study 307 is being conducted at an unproven lower dose of cabo than previously tested, which is likely to reduce the drug's efficacy and make it difficult to win on survival benefit (especially if the control-arm patients live longer than expected.)
- The pain trial, study 306, is of no value on its own for a cancer drug. FDA recognizes three endpoints for prostate cancer drugs -- survival, quality of life and pain reduction -- but if you don't get a survival claim, forget about premium pricing.
Biotech Stock Mailbag: Exelixis, Protalix, Arena
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