The news that Roche will delay filing for approval of its anaemia drug CERA in patients undergoing chemotherapy for cancer, divulged alongside the firm’s annual results, sent shares of rival Amgen up 5% yesterday.
Roche said yesterday it would not file for approval of CERA in this indication until 2009, some two years later than expected, although it still plans to submit a dossier for CERA in anaemia caused by renal disease later this year.
Last month, 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.
But approval in this indication alone would compromise the ability of CERA to compete with Amgen’s Aranesp (darbepoetin alfa), which is cleared for both indications and posted 2005 sales of $3.3 billion. Analysts said the US Food and Drug Administration (FDA) has asked for more data on the oncology indication that will require additional clinical trials.
Roche’s development of CERA has caused a bitter rivalry between the two companies, and Amgen has sued Roche claiming that its new product infringes patents covering both Aranesp and its older anaemia drug, Epogen (epoetin alfa).
If approved, CERA’s once-monthy dosing would make it a strong competitor to Epogen, which is dosed three times a week, and Aranesp which is given every other week.