Antisoma's Oral Fludarabine For Blood Cancer Gets FDA Nod - Update

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Antisoma's Oral Fludarabine For Blood Cancer Gets FDA Nod - Update

12/19/2008 5:26 AM ET

Friday, biopharmaceutical company Antisoma Plc (ASM.L, ATSMY.PK), said it

received approval from the US Food and Drug Administration, or FDA, for its oral

fludarabine as a second-line treatment for chronic lymphocytic leukaemia.

Antisoma stated that its tablet formulation of fludarabine phosphate for

chronic lymphocytic leukemia, or CLL, was granted orphan drug status, providing

seven years of market exclusivity. Antisoma has an exclusive licence from Bayer

Schering Pharma AG to market oral fludarabine in US.

Meanwhile, Antisoma said it intends marketing the drug in US through

commercialization deal, and has been conducting talks to establish an

oncology-marketing operations. Antisoma expects to conclude the deal early in

2009.

While oral and intravenous formulations are in use in Europe and Canada,

US could avail only the intravenous formulation. In France and the UK, the oral

formulation has been widely adopted, representing some 60% to 70% of fludarabine

prescriptions.