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...(quarter of 2008 the Company plans to fil...),Health

Date:9/18/2007

quarter of 2008, the Company plans to file a supplemental new drug application (sNDA) in the U.S. for use of VELCADE in patients with newly diagnosed multiple myeloma, based on the data from this trial, which was conducted under the special protocol assessment (SPA) process with the Food and Drug Administration (FDA). The Company also expects that these data will be presented at the December 2007 meeting of the American Society of Hematology (ASH) in Atlanta, Georgia.

"An approval in front-line multiple myeloma would double the number of patients eligible to receive the benefit of VELCADE," said Nancy Simonian, M.D., Chief Medical Officer, Millennium. "We are confident that VELCADE based therapies will become standard of care, since physicians typically use the most active agents in the front-line setting to improve long-term outcomes for patients."

The Phase III VISTA trial is being conducted by the Company and its co-development partner Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (JJPRD). The trial randomized 682 patients with newly diagnosed multiple myeloma, ineligible for stem cell transplantation, to receive either VMP or MP, a recognized standard of care in this treatment setting. Patients were enrolled at 151 clinical trial sites in 22 countries. The primary endpoint of the trial is time-to-disease progression with secondary endpoints, including overall survival, progression-free survival, complete remission rate and safety. Side effects of the VELCADE based therapy were manageable and included those seen in previous VELCADE clinical trials. Professor Jesus San Miguel, M.D., Hematology Department Head, University Hospital of Salamanca, Spain, is the principal investigator.

Conference Call Announcement

In conjunction with this news release, Millennium will host a webcast today, Tuesday, September 18, 2007 at 8:00 A.M. ET. This webcast can be accessed by visiting the Investors section of the Company's website, '/>"/>

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

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