A very interesting few days for Pharmion (PHRM) and Celgene (CELG) and how they are faring in their product approval efforts in Europe.

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.

Adam Rubenstein

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  • Mar 16 11:21 AM
    perhaps Thalomid becomes the accepted MM component and not Revlomid due to no real differences in efficacy,safety but Thal is less expensive.In fact Celg buys Pharmion for just this reason to control both scenarios and if Vidaza comes through a huge potential plus down the road in their growth story! Thal pricing is much lower than Rev~ $65,000/years treatment. This is the concern of the EC! Thal is the accepted IMid of first choice and Rev is canabalizing and driving up MM cost of therapy! This can only go on for so long before the market takes notice! Perhaps that is why the post merger Celg price seems stuck at 56 at least in the Short term. They will need super sales reported in Q1 to catalize new growth. With MLNM on the brink of 1st line approval of Velcade in MM I do not see that happening!
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