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New England Journal of Medicine Publishes Phase III Results of VELCADE(R) (Bortezomib) for Injection in Previously Untreated Multiple Myeloma Patients
Date:8/27/2008

- Patients in the VELCADE, melphalan and prednisone arm demonstrated a significant survival benefit as well as a 30 percent complete response -

CAMBRIDGE, Mass., Aug. 27 /PRNewswire/ -- Millennium: The Takeda Oncology Company today announced the publication of results from the 682 patient, randomized, Phase III VISTA(1) trial in this week's edition of the New England Journal of Medicine. The results showed a significant survival benefit and a 30 percent complete remission (CR) rate with VELCADE, melphalan and prednisone (VcMP) compared to 4 percent for melaphalan and prednisone (MP) alone in previously untreated multiple myeloma patients. Multiple myeloma is the second most common blood cancer.

(Logo: http://www.newscom.com/cgi-bin/prnh/20080827/NEW076LOGO )

"These data demonstrate that treatment with VELCADE plus melphalan and prednisone leads to a survival benefit and a high complete remission in previously untreated patients with multiple myeloma," said Professor Jesus San Miguel, M.D., Ph.D., Hematology Department Head, University Hospital of Salamanca and Principal Investigator of the trial. "The combination of VELCADE plus melphalan and prednisone is an important new option for these patients."

These data originally were presented at the 2007 American Society of Hematology (ASH) Annual Meeting. Based on these positive trial results, the U.S. Food and Drug Administration approved VELCADE for patients with previously untreated multiple myeloma on June 20, 2008. The Phase III VISTA trial was conducted by Millennium and its co-development partner Johnson & Johnson Pharmaceutical Research & Development, L.L.C. in 151 centers worldwide.

"We are proud to have these data published in such a highly esteemed journal," said Nancy Simonian, M.D., Chief Medical Officer, Millennium. "We're delighted that previously untreated multiple myeloma patient
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SOURCE Millennium
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