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late 2008/early 2009.
-- Protein homeostasis oncology program
-- MLN4924 (novel Nedd8-activating enzyme inhibitor) -- An
investigational new drug (IND) application for MLN4924 was
accepted by the FDA in January 2008 for this small molecule
inhibitor of the novel Millennium discovered target. The Company
expects this molecule will enter Phase I clinical trials in the
first half of 2008. MLN4924 acts by inhibiting Cullin-based
ligases, which are enzymes involved in the regulation of cancer
cell growth and survival. Pre-clinical data showed MLN4924
significantly inhibited tumor growth in xenograft models of
colorectal cancer and several lymphomas.
-- MLN2238 (novel proteasome inhibitor) -- The Company advanced
MLN2238, a wholly-owned second generation proteasome inhibitor, to
the development pipeline. In pre-clinical models, MLN2238 showed
superior efficacy compared to VELCADE with potential in a broader
set of hematological and solid tumors. This molecule is expected
to move forward in both oral and IV routes of administration.
Phase I trials are expected to start in early 2009.
-- The Company and Harvard Medical School announced a collaborative
agreement to conduct research in the area of protein homeostasis,
an emerging field of cancer biology.
2008 Financial Guidance
On January 4, 2008, the Company announced its financial guidance for
2008, as follows:
-- VELCADE U.S. net sales are expected to increase 20 to 30 percent to
$320 million to $345 million;
-- Royalties are expected to be in the range of $175 million to
$185 million;
-- Non-GAAP R&D and non-GAAP SG&A expenses are expected to total
approxima
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