BTG plc: Tolerx Initiates Dosing of Otelixizumab in a Phase III Clinical Trial in Type 1 Diabetes

BTG plc: Tolerx Initiates Dosing of Otelixizumab in a Phase III Clinical Trial in Type 1 Diabetes

BTG plc: Tolerx Initiates Dosing of Otelixizumab in a Phase III Clinical Trial in Type 1 Diabetes

Tolerx to pay milestone of $7.5 million to BTG

London, UK, 6 August 2008: BTG plc (LSE: BGC), the life sciences company, notes today’s announcement by Tolerx, Inc. that it has initiated a pivotal phase III clinical trial of otelixizumab (TRX4) in patients with new onset type 1 diabetes. Initiation of the DEFEND (Durable Response Therapy Evaluation For Early or New Onset Type 1 Diabetes) triggers a milestone payment by Tolerx to BTG of $7.5m.

The DEFEND trial, which is being conducted at multiple centres in North America and Europe, will enrol approximately 240 people aged 18-35 who have been newly diagnosed with type 1 diabetes. It will evaluate whether a single course of TRX4, administered no later than 90- days after the diagnosis of autoimmune type 1 diabetes, can inhibit the destruction of pancreatic beta cells and thereby reduce the amount of administered insulin required to control blood glucose levels. The primary endpoint will be a measurement of C-peptide, which is a surrogate measure of beta cell function.

Louise Makin, BTG’s chief executive officer, commented: "We are delighted that Tolerx has commenced this pivotal phase III trial of TRX4, which could be a significant new treatment option for people with new onset type 1 diabetes. TRX4 is the third of our licensed programmes to enter phase III trials recently, alongside Campath® for MS and abiraterone acetate for prostate cancer, underlining the value of our licensed pipeline."

BTG granted Tolerx worldwide rights to develop and commercialise TRX4 in September 2001. In October 2007, Tolerx entered into an agreement with GlaxoSmithKline to develop and commercialise TRX4 in a range of autoimmune and immune-mediated inflammatory diseases. Under the terms of that collaboration, Tolerx may earn development and sales milestone payments of up to $525m and BTG is entitled to receive 50% of the development and sales milestones paid to Tolerx.

For further information contact:

BTG
Andy Burrows, Director of Investor Relations
+44 (0)20 7575 1741
+44 (0)7990 530605 (mobile)

Christine Soden, Chief Financial Officer
+44 (0)20 7575 1591

Finacial Dynamics
Ben Atwell
+44 (0)20 7831 3113

About BTG
BTG in-licenses, develops and commercialises pharmaceuticals and has a broad pipeline of development programmes targeting neurological and other disorders including varicose veins. The company also has a substantial and growing revenue stream of milestone payments and royalties from out-licensed products. BTG operates from offices in London, Philadelphia and Osaka.

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