Swiss drugmaker Roche moved a step closer to getting its anaemia drug Mircera onto the US market yesterday, after reportedly agreeing to terms laid out by the judge presiding over its patent infringement tussle with Amgen.

Mircera (methoxy polyethylene glycol-epoetin beta) was approved by US regulators back in November last year, but the company has been unable to launch it there because of its ongoing court battle with Amgen, which claims that the drug infringes on its intellectual property surrounding its own erythropoiesis-stimulating agents Epogen (epoetin alfa) and Aranesp (darbepoetin alfa).

In October, a jury in a US district court in Boston agreed that Roche's Mircera indeed infringes on 11 of Amgen erythropoietin patent claims, but US district judge William Young said at the end of February he will consider allowing it onto the market if Roche pays a higher royalty rate on US sales of the product (22.5%) and agrees not to price it higher than Amgen’s drugs.

More convenient rival?
Roche has reportedly now accepted these terms and, if they get the judge’s final stamp of approval, Amgen could soon have to deal with a serious new contender for market share, particularly as Mircera therapy is administered with fewer injections than other ESAs and so could prove to be more convenient option for healthcare professionals and patients.

Indeed, study data suggests that converting dialysis patients from more frequently administered ESAs to once-monthly Mircera could halve the annual time spent on anaemia management in a dialysis centre.

Amgen has certainly been through the mill with its anaemia franchise of late, after a warning that patients treated with ESAs have a higher risk of serious and life-threatening side effects and a greater number of deaths led the US Centers for Medicare and Medicaid Services to limit payments for patients undergoing kidney dialysis, denting sales of the drugs.