Roche has submitted a marketing application for its anaemia treatment CERA, a follow-up to its NeoRecormon product, in the European Union. The Swiss drugmaker is seeking approval to market the drug for anemia associated with chronic kidney disease.
CERA is a long-acting erythropoietin product that is considered to be one of the biggest hopes in Roche’s near-term pipeline and a worthy successor to NeoRecormon (epoetin beta).
The latter product was Roche’s second biggest product in 2005, with sales up 11% to 2.3 billion Swiss francs, but has come under pricing pressure. A newer once-weekly formulation of NeoRecormon (sold by Roche subsidiary Chugai as Epogin) has gone some way to defend the franchise, but CERA’s once-monthly dosing could make a real impact in the marketplace, according to analysts.
Roche has already filed for approval of CERA in the USA, although there rival firm Amgen has it the firm with a lawsuit seeking to block its entry into the market, claiming patent infringement. Amgen sells an EPO product called Epogen (epoetin alfa) as well as a long-acting version called Aranesp (darbepoetin alfa) that is a direct competitor to CERA and achieved sales of $893 million in the first quarter of 2006.
Analysts at Merrill Lynch said the patent litigation with Amgen made it hard to predict overall CERA's sales potential, but they have forecast ex-US sales for the product of 1.3 billion Swiss francs ($1bn) in 2010, which could be hiked further by approval in chemotherapy-induced anaemia.