We were recently granted approval in the U.S. (view press release) and the EU (view press release) for Nexavar in a second indication, liver cancer.  The approvals were based on positive data from the international, Phase 3, placebo-controlled Sorafenib HCC Assessment Randomized Protocol (SHARP) trial, which demonstrated that Nexavar extended overall survival in patients with hepatocellular cancer (HCC), or primary liver cancer, versus those taking placebo by 44% (HHR=0.69; p=0.0006). Presented at the ASCO annual meeting in June 2007, these data showed that median overall survival for Nexavar-treated patients was 10.7 months compared to 7.9 months in those taking placebo (view press release).

Bayer and Onyx halted the SHARP trial in February 2007 when an independent data monitoring committee determined in a pre-scheduled analysis that the overall survival endpoint had been met. There were no significant differences in serious adverse event rates between the Nexavar- and placebo-treated groups, with the most commonly observed serious adverse events in patients receiving Nexavar being diarrhea and hand-foot-skin reaction (view press release).