CAMBRIDGE, Mass., Dec. 14 /PRNewswire-FirstCall/ -- Millennium
Pharmaceuticals, Inc. (Nasdaq: MLNM) today announced that R&D President Bob
Tepper, M.D., is leaving the Company in the first quarter of 2007.
(Logo: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO)
Dr. Tepper was one of the founding executives of Millennium in 1994 and
has steered the Company through its expansion from a drug discovery company
to a fully-integrated biopharmaceutical company with nine novel molecules
in the clinic and a market-leading product, VELCADE(R) (bortezomib) for
Injection, for relapsed multiple myeloma and mantle cell lymphoma.
"Bob was one of a small group of people who had a vision for forming a
new company that could make a difference in the way medicine is discovered
to change the lives of patients," said Millennium President and Chief
Executive Officer Deborah Dunsire, M.D. "Today that vision is a reality and
Millennium is indeed improving the lives of patients with multiple myeloma
and mantle cell lymphoma, with a strong and diverse pipeline behind
VELCADE. I would like to thank Bob for his vision and relentless commitment
to scientific excellence."
The Company is actively recruiting a successor.
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 also is approved in the European
Union after first relapse.
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 (MCL) 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.
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 (ARDS) 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 MM and MCL studies, the most commonly
reported adverse events were asthenic conditions (64%), nausea (55%),
diarrhea (52%), constipation (41%), peripheral neuropathy (39%),
thrombocytopenia (36%), appetite decreased, 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 (SAEs). The most
commonly reported SAEs 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. The Company'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. The Company'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:
Lisa Adler (media) Kyle Kuvalanka (investors)
(617) 444-3285 (617) 761-4734
SOURCE Millennium Pharmaceuticals, Inc.
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Related links:
http://www.millennium.com/
Photo Notes:
NewsCom: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, photodesk@prnewswire.com
http://www.prnewswire.com/comp/114562.html/
CONTACT:
Media, Lisa Adler, +1-617-444-3285, or
Investors, Kyle Kuvalanka, +1-617-761-4734, both of Millennium
Pharmaceuticals, Inc.
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