April 30, 2012
Voraxaze® (glucarpidase) Launched in the US

West Conshohocken, PA, 30 April 2012

BTG International Inc., the specialist healthcare company today announces the launch of Voraxaze® (glucarpidase) in the US. 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. Voraxaze® breaks down methotrexate into 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 available to reduce toxic plasma methotrexate levels.

High dose methotrexate chemotherapy is used to treat or prevent the recurrence of certain cancers, including osteosarcoma, and certain leukemias, and lymphomas. Some patients treated with high dose methotrexate develop impaired kidney function, which leads to the accumulation of toxic levels of methotrexate in the blood resulting in clinical manifestations of 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.

Further information on the symptoms, diagnosis and treatment of methotrexate toxicity is available for US physicians in the US Healthcare Professional area of BTG’s website, accessible through the link at the bottom of this press release.

BTG also announces that the company is partnering with ASD Healthcare, part of the AmerisourceBergen Corporation, to be the sole distributor for Voraxaze® in the US.  Starting today 30 April 2012, ASD Healthcare is accepting customer orders for Voraxaze® at 1.855.7.VORAXAZE (1.855.786.7292) with on-call representatives to process orders 24-hours a day, 365 days a year.

Voraxaze® was approved earlier this year by the FDA 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.

Dosing

Voraxaze® is to be administered as a single intravenous injection of 50 Units per kg.

Safety Information
Most common adverse reactions (incidence >1%) were paresthesias, flushing, nausea and/or vomiting, hypotension and headache.

Healthcare providers should note that:

• Methotrexate concentrations within 48 hours following glucarpidase administration can only be reliably measured by a chromatographic method due to interference from metabolites [4-deoxy-4-amino-N10-methylpteroic acid (DAMPA)]. Measurement of methotrexate concentrations within 48 hours of glucarpidase administration using immunoassays can overestimate the methotrexate concentration.
• Leucovorin should not be administered within 2 hours before or after a glucarpidase dose because leucovorin is a substrate for glucarpidase.

For further information please contact:

BTG
Ashley Tapp, Communications Manager
Tel: +44 (0)20 7575 1513
Mobile: +44 (0)7790 811554