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treatment for relapsed multiple myeloma and mantle cell lymphoma.
Sales increased steadily throughout the year as a result of the
increasing impact of the Company's enhanced sales and marketing
programs, which improved share-of-voice for the product in the market.
-- The Company submitted a supplemental New Drug Application (sNDA) to
the U.S. Food and Drug Administration (FDA) in December 2007 for
VELCADE expansion into newly diagnosed multiple myeloma. The filing,
based on data from the Phase III VISTA trial, conducted with its
co-development partner, Johnson & Johnson Pharmaceutical Research &
Development, L.L.C. (J&JPRD), was granted priority review by the FDA.
The FDA decision date for the sNDA is scheduled for June 20, 2008.
J&JPRD submitted a corresponding marketing application to the European
Medicines Evaluation Agency (EMEA).
-- Data from three large, well-controlled Phase III clinical trials of
VELCADE based combinations in newly diagnosed multiple myeloma were
featured at the 2007 Annual Meeting of the American Society of
Hematology (ASH). These trials are part of a comprehensive development
program designed to establish VELCADE as a critical component of the
standard of care regimens in the multiple myeloma transplant and
non-transplant settings. Data from the three Phase III trials are as
follows:
-- VISTA -- The combination therapy of VELCADE, melphalan and
prednisone (VcMP) showed statistically significant improvement
across all efficacy endpoints when compared to melphalan and
prednisone (MP) alone in 682 patients ineligible for stem cell
transplantation (SCT). Patients treated with VcMP had a 35 percent
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| SOURCE Millennium Pharmaceuticals, Inc. Copyright©2008 PR Newswire. All rights reserved |