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Antisoma receives FDA approval for oral fludarabine, plans commercialisation deal to bring drug to US patients

23 Dec 2008 - Antisoma plc announced that the United States Food and Drug Administration (FDA) has approved its tablet formulation of fludarabine phosphate ('oral fludarabine') as a second-line treatment for chronic lymphocytic leukaemia (CLL).
 
Oral fludarabine provides an alternative means to administer fludarabine that avoids the need for patients to have an intravenous infusion. Antisoma plans to make the drug available to US patients through a commercialisation deal. Talks are ongoing with a number of companies that have established oncology marketing operations in the US. Antisoma expects to conclude a deal early in 2009.
 
Glyn Edwards, Antisoma's CEO, said: "We are delighted that the FDA has cleared oral fludarabine for marketing in the US, giving Antisoma its first product approval. This puts us in a very good position to conclude a commercialisation deal for the drug. We anticipate a deal that allows us to realise the full value of oral fludarabine while placing the drug with a partner who can make it available as soon as possible as a new treatment option for US patients with CLL."