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Phase III Clinical Trial in Newly Diagnosed Multiple Myeloma Stopped Early Due to Highly Significant Efficacy Advantage of VELCADE(R) (Bortezomib) for Injection Based Therapy Across All Endpoints
Date:9/18/2007

- Millennium on track to file sNDA in first quarter 2008 -

CAMBRIDGE, Mass., Sept. 18 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM) today announced that the interim analysis results of the large, international Phase III VISTA(1) trial in patients with newly diagnosed multiple myeloma showed that the therapy of VELCADE, melphalan and prednisone (VMP) demonstrated a highly statistically significant improvement in all efficacy measures, including time-to-disease progression, complete remission rate, progression-free survival and overall survival, compared to melphalan and prednisone (MP) alone. Based on the recommendation of an independent data monitoring committee (IDMC), which conducted the planned interim, the control arm of the trial was stopped early to allow patients still being treated with MP to have VELCADE added to their therapy.

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"These results position VELCADE based therapy as a new standard of care for newly diagnosed multiple myeloma patients," said Paul Richardson, M.D., Associate Professor of Medicine, Harvard Medical School; Clinical Director, Jerome Lipper Multiple Myeloma Center Dana-Farber Cancer Institute Boston; and a lead investigator of the VISTA trial. "The combination of VELCADE with melphalan and prednisone surpassed all efficacy endpoints, including time-to-disease progression, complete remission rate, progression-free survival and overall survival, and did so, much earlier than expected. We are excited at the possibility this new therapy could be available to our patients sooner."

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SOURCE Millennium Pharmaceuticals, Inc.
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