BTG plc: Voraxaze® (glucarpidase) receives US regulatory approval

London, UK, 18 January 2012: BTG plc (LSE: BGC), the specialist healthcare company, today announces that it has received regulatory approval from the US Food and Drug Administration (FDA) for its Biologics License Application (BLA) for Voraxaze® (glucarpidase). The approval of Voraxaze® was granted under priority review, a designation that is given to therapies that offer major advances in treatment or provide a treatment where there is no adequate alternative therapy.

Voraxaze® is indicated for the treatment of toxic plasma methotrexate concentrations (>1 micromole per liter) in patients with delayed methotrexate clearance due to impaired renal function. It works by breaking down methotrexate into its inactive metabolites which are then eliminated from the body by routes other than the kidney (primarily the liver). Voraxaze® is the first and only drug able to reduce toxic plasma methotrexate levels.

High dose methotrexate chemotherapy is used to treat or prevent the recurrence of certain types of cancer, such as osteosarcoma, leukemia, and lymphoma. Some patients treated with methotrexate develop impaired kidney function, which leads to the accumulation of toxic levels of methotrexate in the blood and puts patients at risk of additional toxicity.

The most common related adverse events in clinical trials were paresthesia (a sensation of tingling or burning on the skin), flushing, nausea, vomiting, hypotension and headache.

Louise Makin, Chief Executive Officer of BTG, commented: "Voraxaze® is the first product BTG has taken through to approval in the US and we look forward to its launch over coming months. It will be sold by our existing specialty pharmaceuticals sales force, with the addition of a few extra personnel, alongside our established emergency room medicines, CroFab® and DigiFab®."

Guenter R. Janhofer, Chief Medical Officer and Head of Development at BTG, added: "Today's FDA approval of Voraxaze® has the potential to help patients in the rare event that they experience delayed methotrexate elimination due to impaired renal function. In the clinical trials which led to approval, patients achieved rapid and sustained reductions in plasma methotrexate concentrations."

Clinical Trials

The FDA approval is based upon data from 290 patients who were treated in 2 single-arm, open-label, multicentre trials.The median age was 17 years (1 month to 85 years), 64% were male, 32% had osteogenic sarcoma or sarcoma and 63% had leukemia or lymphoma.

The FDA approval was based on the pharmacodynamic endpoint of a rapid and sustained clinically important reduction (RSCIR) in plasma methotrexate concentration, defined as an attainment of plasma methotrexate concentration

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