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Millennium begins phase III trial for Velcade myeloma combination therapy

Millennium Pharmaceuticals has revealed it will expand the use of its Velcade blood cancer treatment

US-headquartered Millennium Pharmaceuticals has revealed it will expand the use of Velcade (bortezomib), its multiple myeloma or blood cancer treatment.

The injectable drug, which is being co-developed by Millennium and J&J Pharmaceutical Research & Development, is currently approved for the treatment of patients with multiple myeloma who have received at least one prior therapy. Velcade is also indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.

The phase III UPFRONT trial will determine the most effective Velcade-based combination therapy with approved agents for the treatment of newly diagnosed multiple myeloma patients, ineligible for stem cell transplantation.

The trial's primary end point is progression-free survival and secondary endpoints including duration of response, overall survival and overall safety / tolerability. The three treatment arms are Velcade and Dexamethasone (VD); Velcade, Thalidomide and Dexamethasone (VTD); and Velcade, Melphalan and Prednisone (VMP). About 500 patients are expected to be enrolled in the trial and will remain on treatment for up to one year.

In FY06, US sales of Velcade were approximately USD 220.5m, which represented approximately 45 per cent of Millennium's total revenue for 2006. This compares with FY05 sales of approximately USD 192.1m, which represented approximately 34 per cent of total revenue for that time period.

18th July 2007

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