NEW DRUG TO TREAT CHRONIC LYMPHOCYTIC LEUKAEMIA LIKELY TO GO ON SALE BY END OF THE YEAR

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NEW DRUG TO TREAT CHRONIC LYMPHOCYTIC LEUKAEMIA LIKELY TO GO ON SALE BY END OF THE YEAR
14 October 2006 - BTG

BTG, the global technology commercialisation company, announced today that the U.S. Food & Drug Administration has granted accelerated approval of Campath (alemtuzumab) humanised monoclonal antibody for use as a treatment for patients with B-cell chronic lymphocytic leukaemia who have been treated with alkylating agents and have failed fludarabine therapy.

CLL is the most prevalent form of adult leukaemia, affecting approximately 120,000 patients in the U.S. and Europe. Together with the European Medicines Evaluation Agency's Committee on Proprietary Medicinal Products opinion last month, it is anticipated that Campath will be launched in the U.S and Europe this year, with product being available in the U.S. in early June and later in the year in Europe.

Campath is licensed by BTG to Millennium Pharmaceuticals, Inc., and was developed by M&I Partners, a 50-50 joint venture of Millennium and ILEX Oncology, Inc. Campath will be marketed and distributed in the U.S. by Berlex Laboratories, a subsidiary of Schering AG, Germany. Under the terms of the licensing arrangement, BTG will receive royalties based on product sales.

With this accelerated approval, Campath will become the first monoclonal antibody to be approved for the treatment of CLL and the first new drug indicated for the treatment of CLL in nearly ten years. "Accelerated approval" requires that M&I Partners conducts a confirmatory study of Campath versus chlorambucil, the standard frontline treatment, to further examine Campath's safety and efficacy in CLL patients. This post-approval trial is planned to begin later this year.

The news follows the announcement last month that The European Medicines Evaluation Agency's Committee on Proprietary Medicinal Products has recommended approval under exceptional circumstances.

Ian Harvey, CEO of BTG plc, said: "Campath is the third new drug to come out of BTG's strong, and growing, oncology portfolio in the last decade. This is exciting news for BTG since Campath has the potential to be a major source of revenue for the group".

http://www.btgplc.com

About: BTG
BTG is an intellectual property and technology commercialisation company that operates internationally. BTG creates value by investing in intellectual property and technology development, and in early stage ventures. We realise value through technology licensing, patent assertion and sale of equity investments. Through a multidisciplinary approach, we apply intellectual property and commercial expertise, together with specialist skills in science and technology, to create major product opportunities in the health and high tech sectors. BTG has commercialised important innovations, including Magnetic Resonance Imaging, Multilevel Cell Memory, Campath (alemtuzumab), the first monoclonal antibody treatment for chronic lymphocytic leukaemia, and recombinant Factor IX blood clotting protein. BTG operates through wholly owned subsidiaries BTG International Ltd and BTG International Inc in the UK and USA, respectively.

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