December 07, 2011
BTG plc: Voraxaze® (glucarpidase) licensed to Ohara Pharmaceuticals in Japan

London, UK, 07 December 2011

BTG plc (LSE: BGC), the specialist healthcare company, today announces that it has licensed the Japanese rights to glucarpidase to Ohara Pharmaceutical Co., Ltd. (Ohara) of Japan.

Under the terms of the license agreement BTG will also supply glucarpidase to Ohara. Ohara will be responsible for the development programme and registration in Japan. Ohara plans to work in partnership with leading oncologists who will execute clinical trials in a development programme for glucarpidase. This is a clinical trial project funded by a Health and Labour Sciences Research Grant from the Ministry of Health, Labour and Welfare (MHLW). An IND application for glucarpidase in Japan was submitted to the Pharmaceuticals and Medical Devices Agency (PMDA) on December 5th. Should glucarpidase be successfully developed and approved, Ohara Pharmaceuticals will have the rights to market and sell glucarpidase in Japan.

Dr Richard Mason, BTG’s Head of Business Development commented “Ohara Pharmaceuticals are an ideal partner for glucarpidase as they are developing an orphan drug business in Japan and have access to specialist knowledge for oncology products.”

Glucarpidase is an experimental treatment for the rapid and sustained reduction of toxic methotrexate (MTX) levels due to impaired renal function. High dose MTX chemotherapy is used to treat or prevent the recurrence of certain types of cancer in both adults and children, such as leukaemia, lymphoma and osteosarcoma. Patients may be considered at risk of MTX toxicity if they have developed impaired renal function, which can lead to a delay in elimination of MTX from the body.

Glucarpidase is not yet approved in any country. Glucarpidase is currently available in the US under an expanded access IND and cost recovery programme and in selected countries outside the US on a named patient basis. The FDA accepted a Biologics License Application (BLA) for glucarpidase in September 2011 and a Priority Review was granted. The FDA’s goal for completing the BLA review is 17 January 2012.

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