The European Medicines Agency issued a positive opinion to recommend approval of Pharmion’s Thalidomide for use in combination with melphalan and prednisone as first line treatment for patients with untreated multiple myeloma, aged 65 years or older or ineligible for high dose chemotherapy. Such an opinion often yields a final marketing approval via the European Commission, typically to occur within the window of a quarter. So let’s hope for smooth sailing over the next 12-weeks or so on Thalidomide.
On a less positive note for Celgene, a European advisory committee recommended against approving its drug Revlimid as a treatment for anemia patients (the drug is already approved to treat multiple myeloma). The European Medicines Agency's Committee for Medicinal Products for Human Use recommended against expanding Revlimid's approval to include treating transfusion-dependent anemia patients with blood disorders known as myelodysplastic syndrome.
Recall that the share price of CELG will effect the final terms in the Pharmion acquisition.