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Millennium Reports Outstanding Third-Quarter Results Driven by VELCADE(R) (Bortezomib) for Injection Sales
Date:11/1/2007

physicians prescribing VELCADE," said Christophe Bianchi, M.D., Executive Vice President, Commercial, Millennium. "The future of VELCADE is even more exciting as we look to expand into front-line multiple myeloma with several combinations that have the potential to deliver the strongest long- term survival for patients."

-- Phase III VISTA Trial in Front-Line Multiple Myeloma (MM) -- The

Company announced that the results of the large, randomized, Phase III

VISTA trial in patients with newly diagnosed MM showed that the therapy

of VELCADE, melphalan and prednisone demonstrated a highly

statistically significant improvement, compared with melphalan and

prednisone alone, across all efficacy endpoints, including time to

progression, complete remission rate, progression free survival and

overall survival. Side effects were manageable and included those seen

in previous VELCADE trials. Based on these positive data, the control

arm of the trial was stopped early to allow patients still being

treated with melphalan and prednisone to have VELCADE added to their

therapy. The Company now expects to file a supplementary new drug

application (sNDA) for use of VELCADE in patients with newly diagnosed

MM in December 2007.

-- Compendia Listing in Front-Line MM -- In October 2007, the national

compendia organization DrugPoints Systems included VELCADE as a

recommended therapy for use in newly diagnosed multiple myeloma

patients.

-- Label Expansion in MM -- In October 2007, the U.S. Food and Drug

Administration (FDA) granted approval for VELCADE use, without dose

adjustments, in patients with impaired kidney function, including those

requiring dialysis. Impaired kidney function is a common complication

related to MM, affecting approximately 30 percent of patients at

diagnos
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SOURCE Millennium Pharmaceuticals, Inc.
Copyright©2007 PR Newswire.
All rights reserved

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