CHICAGO, June 3 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals,
Inc. (Nasdaq: MLNM) today presented results of research on a new oncology
molecule, MLN4924, a first-in-class, small molecule inhibitor of the Nedd 8
Activating Enzyme (NAE). NAE is a novel Millennium-discovered target in the
protein homeostasis pathway. NAE acts upstream of the proteasome, the
target of VELCADE(R) (bortezomib) for Injection, the Company's
market-leading therapy for patients with previously treated multiple
myeloma and mantle cell lymphoma. The data on NAE were presented at the
43rd Annual Meeting of the American Society of Clinical Oncology (ASCO) in
Chicago.
(LOGO: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO )
"Millennium is a leader in protein homeostasis research, and our
discoveries of NAE and MLN4924 demonstrate our strength and innovation in
this unique area," said Joe Bolen, Ph.D., Chief Scientific Officer,
Millennium. "Building on the clinical and commercial success of VELCADE, we
believe that MLN4924 has the potential to deliver enhanced efficacy with an
improved safety profile in a broad range of solid and hematological tumors.
The preclinical work conducted to date has shown that MLN4924 has
substantial and durable anti-tumor activity."
Data presented by Mark Rolfe, Ph.D., Vice President, Millennium
Oncology Discovery, showed:
-- NAE is a novel target in the protein homeostasis pathway that
specifically controls a subset of proteins which regulates survival of
cancer cells
-- NAE has been validated as an oncology target in hematological and solid
tumors
- Molecular pathology studies have shown elevated NAE expression in
primary human tumors including colon, lung and ovarian as well as
colon metastasis to the liver
- Conversely, NAE expression is low in normal human tissues
-- MLN4924 has shown substantial activity in a broad range of preclinical
solid and hematological tumor models
The Company is currently conducting investigational new drug (IND)
enabling work for MLN4924 and expects to enter human clinical trials with
the molecule in advanced cancer patients in 2008.
About VELCADE
VELCADE is being co-developed by Millennium Pharmaceuticals, Inc. and
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Millennium
is responsible for commercialization of VELCADE in the U.S., Janssen-Cilag
is responsible for commercialization in Europe and the rest of the world.
Janssen Pharmaceutical K.K. is responsible for commercialization in Japan.
For a limited period of time, Millennium and Ortho Biotech Inc. will
co-promote VELCADE in the U.S. VELCADE is approved in more than 80
countries worldwide.
In the U.S., VELCADE is indicated for the treatment of patients with
multiple myeloma who have received at least one prior therapy. VELCADE is
indicated for the treatment of patients with mantle cell lymphoma who have
received at least one prior therapy. VELCADE is contraindicated in patients
with hypersensitivity to bortezomib, boron, or mannitol. VELCADE should be
administered under the supervision of a physician experienced in the use of
antineoplastic therapy. In the European Union and many other countries
worldwide, VELCADE is approved for patients with multiple myeloma after
first relapse.
Risks associated with VELCADE therapy include new or worsening
peripheral neuropathy, hypotension observed throughout therapy, cardiac and
pulmonary disorders, gastrointestinal adverse events, thrombocytopenia,
neutropenia and tumor lysis syndrome. Women of childbearing potential
should avoid becoming pregnant while being treated with VELCADE. Cases of
severe sensory and motor peripheral neuropathy have been reported. The
long-term outcome of peripheral neuropathy has not been studied in mantle
cell lymphoma. Acute development or exacerbation of congestive heart
failure, and/or new onset of decreased left ventricular ejection fraction
has been reported, including reports in patients with few or no risk
factors for decreased left ventricular ejection fraction. There have been
rare reports of acute diffuse infiltrative pulmonary disease of unknown
etiology such as pneumonitis, interstitial pneumonia, lung infiltration and
Acute Respiratory Distress Syndrome in patients receiving VELCADE. Some of
these events have been fatal. A higher proportion of these events have been
reported in Japan. There have been rare reports of RPLS in patients
receiving VELCADE. RPLS is a rare, reversible, neurological disorder which
can present with seizure, hypertension, headache, lethargy, confusion,
blindness, and other visual and neurological disturbances. VELCADE is
associated with thrombocytopenia and neutropenia. There have been reports
of gastrointestinal and intracerebral hemorrhage in association with
VELCADE. Transfusions may be considered. Complete blood counts (CBC) should
be frequently monitored during treatment with VELCADE. Rare cases of acute
liver failure have been reported in patients receiving multiple concomitant
medications and with serious underlying medical conditions.
Safety Data: In 1163 patients in multiple myeloma and mantle cell
lymphoma studies, the most commonly reported adverse events were asthenic
conditions (64%), nausea (55%), diarrhea (52%), constipation (41%),
peripheral neuropathy (39%), thrombocytopenia (36%), appetite decrease,
including reports of anorexia (36%), pyrexia (34%), vomiting (33%) and
anemia (29%). Twenty percent of patients reported at least one episode of
grade 4 toxicity; the most common grade 4 toxicities were thrombocytopenia
(5%) and neutropenia (3%). Fifty percent of patients reported serious
adverse events. The most commonly reported serious adverse events were
pneumonia (7%), pyrexia (6%), diarrhea (5%), vomiting (4%), and nausea,
dehydration, dyspnea and thrombocytopenia (each 3%).
For more information about VELCADE clinical trials, patients and
physicians can contact the Millennium Medical Product Information
Department at 1-866-VELCADE (1-866-835-2233).
About Millennium
Millennium Pharmaceuticals, Inc., a leading biopharmaceutical company
based in Cambridge, Mass., markets VELCADE, a novel cancer product, and has
a robust clinical development pipeline of product candidates. Millennium's
research, development and commercialization activities are focused in two
therapeutic areas: oncology and inflammation. By applying its knowledge of
the human genome, understanding of disease mechanisms and industrialized
drug discovery platform, Millennium is developing an exciting pipeline of
innovative product candidates. Millennium's website is http://www.millennium.com.
This press release contains "forward-looking statements," including
statements about the Company's growth and development of products. Various
important risks may cause the Company's actual results to differ materially
from the results indicated by these forward-looking statements, including:
adverse results in its drug discovery and clinical development programs;
failure to obtain patent protection for its discoveries; commercial
limitations imposed by patents owned or controlled by third parties; the
Company's dependence upon strategic alliance partners to develop and
commercialize products and services based on its work; difficulties or
delays in obtaining regulatory approvals to market products and services
resulting from its development efforts; product withdrawals; competitive
factors; difficulties or delays in manufacturing the Company's products;
government and third-party reimbursement rates; the commercial success of
VELCADE and INTEGRILIN(R) (eptifibatide) Injection; achieving revenue
consistent with internal forecasts; and the requirement for substantial
funding to conduct research and development and to expand commercialization
activities. For a further list and description of the risks and
uncertainties the Company faces, see the reports it has filed with the
Securities and Exchange Commission. The Company disclaims any intention or
obligation to update or revise any forward- looking statements, whether as
a result of new information, future events or otherwise.
Contacts:
Jennifer Snyder (media) Kyle Kuvalanka (investors)
(617) 448-0281 (857) 498-0818
SOURCE Millennium Pharmaceuticals, Inc.
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Related links:
http://www.millennium.com/
Photo Notes:http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, photodesk@prnewswire.com
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CONTACT:
Media, Jennifer Snyder, +1-617-448-0281, or
Investors, Kyle Kuvalanka, +1-857-498-0818, for Millennium
Pharmaceuticals, Inc.
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