Roche has completed its pivotal trials programme for CERA, its candidate treatment for anaemia that is tipped as a potential successor for its NeoRecormon and Epogin products.
The Swiss drugmaker presented data from four Phase III clinical trials of the red blood cell stimulator which showed that the drug, given once every four weeks, was effective in preventing anaemia in patients with renal failure who were on dialysis.
Roche said it is now on track to file for approval of CERA, tipped as a blockbuster by analysts, during 2006.
CERA is a long-acting product that would offer improved dosing compared to NeoRecormon and Epogin, which reported first-half sales of around $850 million dollars. But Roche’s anaemia franchise is facing patent challenges from generic competitors, and the company wants to move quickly towards a CERA launch to offset the risk of copycats taking its market share.
But CERA is something of an unknown quantity in terms of its sales potential, as the product is the subject of a patent infringement lawsuit in the USA between Roche and Amgen, which sells a rival product called Epogen (epoetin alfa).
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.