THE U.S. FDA ONCOLOGIC ADVISORY COMMITTEE RECOMMENDS NEW TREATMENT, CAMPATH

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THE U.S. FDA ONCOLOGIC ADVISORY COMMITTEE RECOMMENDS NEW TREATMENT, CAMPATH
28 October 2002 - BTG

BTG plc announces that the Oncologic Drug Advisory Committee to the U.S. Food & Drug Administration voted yesterday 14 to 1 to recommend accelerated approval of CAMPATH.

CAMPATH (Alemtuzumab) is an investigational humanised monoclonal antibody for patients with 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.

'Accelerated approval' requires that M&I Partners conduct further studies in order to verify and describe the compound's clinical benefit. A post-approval clinical trial, to examine the product's safety.

BTG licensed CAMPATH to LeukoSite, Inc, which in turn sub-licensed the antibody to a 50-50 joint venture with ILEX Products Inc., a subsidiary of ILEX Oncology Inc. This joint venture became M&I Partners following the 1999 acquisition of LeukoSite by Millennium Pharmaceuticals. CAMPATH will be marketed and distributed in the U.S. by Berlex Laboratories, Inc., a subsidiary of Schering AG, Germany. Under the terms of the licensing arrangement, BTG receives royalties on sales of the product.

The Advisory Committee's recommendation is not binding, but it will be taken into consideration by the FDA upon completing review of the CAMPATH Biologics. The FDA has granted CAMPATH 'fast track' and orphan drug designations. In addition, M&I Partners submitted a Marketing Authorisation Application for CAMPATH to the European Agency for the Evaluation of Medicinal Products for evaluation, which is currently under review.

The ODAC reviewed efficacy data from a pivotal Phase II clinical trial, as well as two earlier supporting studies, involving a total of 149 patients with CLL. Of the 149, 147 had received at least one regimen containing an alkylating agent, 128 patients had been previously treated with fludarabine and 126 patients received both types of chemotherapy. The pivotal study results showed 33 percent of the patients involved achieved a response to CAMPATH which exceeded the protocol specified target response rate of 20 percent.

CLL is characterised by an accumulation of leukaemic cells in the bone marrow, blood and other tissues, causing bone marrow dysfunction and enlargement of the lymph nodes, liver and spleen. Investigators believe CAMPATH works by targeting the CD52 antigen, which is prevalent on cancerous B-lymphocytes, to clear the blood and bone marrow of cancer cells.

"The panel's announcement today is a welcome step forward for patients suffering from CLL," said Ian Harvey, CEO of BTG plc. "This is good news for BTG and our shareholders. If ultimately approved and launched, royalties from CAMPATH would represent a significant stream of revenues to BTG."

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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