Shares in US drugmakers MGI Pharma and SuperGen were on the slide yesterday after the companies announced that Dacogen (decitabine), their drug for the blood disorders known as myelodysplastic syndromes, could be delayed in Europe.
In a statement, they said the European Medicines Agency might ask for more data before approving the drug. MGI and SuperGen are currently looking for a marketing partner to take Dacogen forward in Europe, and said they may wait for this partner to be upon board before finalising their European strategy for the drug. They expect to update on the drug’s progress in Europe by the end of the year.
Meanwhile, the companies also received an ‘approvable’ letter for Dacogen from the US Food and Drug Administration (FDA) last month, and are still drawing up their response to the issues it raised.
MGI's shares closed down 6% to $18.91 dollars on the announcement yesterday, while SuperGen initially dropped but finished the day flat at $5.98. MGI acquire the worldwide rights to Dacogen from SuperGen last year in a deal valued at up to $85 million [[02/09/04h]].
Dacogen is just one of a crop of new drugs approved or in development for MDS. The others include Celgene’s Revlimid (lenalidomide), Cell Therapeutics' Trisenox (arsenic trioxide) and Pharmion's Vidaza (azacitidine) [[14/10/05b]].