Hematide Turns

The goal of Affymax Inc.'s Phase III program for Hematide peginesatide was to show that the once-monthly ESA had equivalent safety and efficacy to marketed ESAs to treat anemia in patients with chronic kidney disease. But Phase III results disclosed last week showed an increased rate of cardiovascular events in non-dialysis patients. As a result, FDA's worries about ESAs in general could mean Hematide's prospects are grim unless the company can identify a way to prospectively identify patients who would be at risk of the adverse response.

Affymax also needs to figure out why some of the study data did not appear to confirm the presumed dosing benefits of the pegylated form of the ESA...