Switzerland’s Roche has said that its red blood cell stimulator CERA (R744) can control anaemia in patients with chronic kidney disease who are not receiving dialysis, according to results from a year long, Phase II clinical trial.
The small-scale study, involving 51 patients, found that CERA helped maintain target red blood cell levels, whether the drug was given every three weeks, once every other week or once-weekly. Earlier studies found that the drug was also effective in patients on dialysis.
Roche has just been served with a lawsuit from US biotechnology giant Amgen, which insists that CERA infringes patents held by its established anaemia treatment Epogen (epoetin alfa) [[10/11/05b]]. If approved, CERA would be a competitor to Epogen, which is dosed three times a week, and long-acting follow-up Aranesp, given every other week. Together, these products bring in revenues upwards of $5 billion a year for Amgen.
CERA is currently in Phase III testing and Roche plans to submit the drug for approval in the first half of next year.