MGI Pharma and SuperGen have won approval in the USA for Dacogen, a new drug for the treatment of patients with myelodysplastic syndromes, a group of bone marrow diseases that can progress to acute leukaemia, and say they plan to launch the product in the second quarter.
Results from a Phase III clinical trial demonstrated an overall response rate of 21% in Dacogen-treated patients considered evaluable for response, defined as those patients with pathologically confirmed MDS at baseline who received at least two cycles of treatment, with no responses seen among patients receiving just supportive care.
MGI Pharma chief executive, Lonnie Moulder, said he expected the drug to achieve sales of around $250 million at peak.
Development of the drug in Europe depends on MGI Pharma and SuperGen securing a local marketing partner, which should prove easier now that the drug has won approval in the USA.
Dacogen will compete in the USA with Pharmion’s Vidaza (azacitidine), which was approved in 2004 and achieved sales of $125 million last year. Meanwhile, other drugs approved or in development for MDS include Celgene's Revlimid (lenalidomide) and Cell Therapeutics' Trisenox (arsenic trioxide).