Millennium Announces Clinical Updates at Analyst Day Meeting
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CAMBRIDGE, Mass., Nov. 2 /PRNewswire-FirstCall/ -- Millennium
Pharmaceuticals, Inc. (Nasdaq: MLNM) today provided clinical development
updates at its annual Analyst Day in New York City. Millennium reported key
clinical advancements in the development of VELCADE(R) (bortezomib) for
Injection, its market-leading drug in relapsed multiple myeloma. These
updates included the use of VELCADE in front line multiple myeloma, mantle
cell and follicular lymphoma, non-small cell lung cancer, and key advances
with other molecules. The Company also provided further details regarding its
refined strategy to shift resources toward the inflammation and oncology
development pipeline as well as commercial efforts in oncology.
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"Today's oncology and inflammation advancements are the result of our
strengths in delivering high-value molecules through a rigorous proof-of-
concept process, a proactive regulatory approach, and aggressive commercial
strategies," said Deborah Dunsire, M.D., president and chief executive officer
of Millennium. "By realigning resources to focus on the most promising
opportunities and maintaining a strong fiscal discipline, Millennium continues
its drive toward non-GAAP profitability in 2006 and growth beyond."
Oncology Clinical Updates
Robert Tepper, M.D., president of research and development of Millennium,
presented details of the Company's product pipeline which includes eight
molecules in the clinic; four of which were developed by Millennium
scientists.
Non-Hodgkin's Lymphoma
The Company announced today its intention to file a supplemental New Drug
Application (sNDA) for VELCADE in mantle cell lymphoma in the second half of
2006. The Company, together with co-development partner, Johnson & Johnson
Pharmaceutical Research & Development, L.L.C. (J&JPRD), recently completed a
phase II study of VELCADE as a single-agent in mantle cell lymphoma patients.
Analysis of the data is currently underway, with final data anticipated in the
first half of 2006.
Management also announced completed enrollment of 81 patients in a phase
II study of VELCADE in relapsed follicular lymphoma, a type of Non-Hodgkin's
lymphoma. The trial compared rituximab alone and in combination with VELCADE.
Updated data will be presented at the American Society of Hematology meeting
in December of this year. Planning for a phase III study of VELCADE in
relapsed follicular lymphoma is underway with a potential start date in the
second half of 2006.
Non-Small Cell Lung Cancer
Dr. Tepper presented interim survival data in non-small cell lung cancer
from a phase II study of VELCADE as a front line treatment. The analysis,
conducted by the Southwest Oncology Group, found that VELCADE in combination
with gemcitabine and carboplatin, showed a median five-month progression-free
survival and a median 11 month overall survival. Based on these and other
results, the Company and J&JPRD are exploring clinical rationale, trial design
and funding options for possible next steps.
Second Generation Proteasome Inhibitors
Dr. Tepper unveiled details of the Company's second-generation proteasome
inhibitor platform which is a large, ongoing initiative aimed at enhancing
safety and efficacy, exploring new boronates and other new chemotypes and
developing novel chemistry upstream in the pathway. The Company plans to
advance a second-generation proteasome inhibitor development candidate by the
end of 2006.
Inflammation Clinical Update
The Company anticipates entering the oral, selective IKK inhibitor,
MLN0415, into the clinic next year. This small molecule would inhibit IKK
beta similar to VELCADE, by inhibiting NFkB. Preclinical data suggest that
this molecule has activity across a variety of diseases including rheumatoid
arthritis, multiple sclerosis, and chronic obstructive pulmonary disease. The
Company's initial phase I study is expected to begin in the second half of
2006. This molecule is part of the sanofi-aventis development and
commercialization collaboration.
The webcast of the Analyst Day event will be archived for 30 days and may
be accessed by visiting the Investors section of the Company's website,
millennium.com.
About VELCADE
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