Protherics submits Biologics License Application for Voraxaze

By Elaine Rigoli

Tampa, Fla., Sept. 18 - Protherics plc has submitted a Biologics License Application to the Food and Drug Administration for Voraxaze, an adjunctive therapy for patients experiencing or at risk of toxicity from methotrexate, a widely used anticancer agent.

Patients are considered at risk of methotrexate toxicity if they have impaired renal function, which can lead to a delay in elimination, or have evidence of delayed elimination based on methotrexate levels.

The London biopharmaceutical company said clinical trials in the United States and Europe have shown that Voraxaze rapidly and predictably reduces methotrexate concentration in the blood of patients in whom its elimination has been delayed. This reduces the risk of serious toxicities and death, which can result from prolonged exposure to methotrexate following high dose methotrexate therapy.

Protherics said it expects to gain marketing approval in the second half of 2007.

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