London, UK; Brentwood, TN, US; 7 November 2006 - Protherics PLC (“Protherics” or the “Company”), the international biopharmaceutical company focused on critical care and cancer, today announces that following the submission of the Biologicals License Application (“BLA”) for Voraxaze™ to the Food and Drug Administration (“FDA”) in the US on 15 September 2006, the FDA has requested additional manufacturing data. As a result, Protherics has withdrawn the BLA with the intention of resubmitting once the additional data has been generated in 2007. Voraxaze™ is an adjunctive therapy for patients experiencing, or at risk of, toxicity from methotrexate (“MTX”), a widely used anti-cancer agent.
