- Three large, randomized Phase III trials of VELCADE in front-line
multiple myeloma to be featured as oral presentations at the American
Society of Hematology (ASH) Annual Meeting -
CAMBRIDGE, Mass., Nov. 26 /PRNewswire-FirstCall/ -- Millennium
Pharmaceuticals, Inc. (Nasdaq: MLNM) today announced that new data from
more than 130 abstracts of VELCADE clinical studies are scheduled to be
featured at the 49th ASH Annual Meeting in Atlanta, Georgia, December 8-11,
2007. The data will highlight the significant efficacy of VELCADE in
multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL).
(Logo: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO )
"VELCADE based therapies have unprecedented complete remission rates
and survival benefits in multiple myeloma," said Nancy Simonian, M.D.,
Chief Medical Officer, Millennium. "Data to be presented at ASH from three
large, randomized Phase III trials will support the expansion of our
market-leading therapy into the front-line multiple myeloma setting."
Front-Line Multiple Myeloma
Data to be featured at ASH will continue to build on the growing body
of evidence that supports the use of VELCADE in both newly diagnosed
transplant and non-transplant patients. The data from a total of 20 Phase
II and Phase III front-line studies will highlight the efficacy of VELCADE
based therapies with consistently high CR and survival benefits. Phase III
presentation highlights are scheduled to include:
-- A Phase III Study Comparing VELCADE, Melphalan and Prednisone (VMP)
with Melphalan Prednisone (MP) in Newly Diagnosed Multiple Myeloma
- Lead investigator: Jesus San-Miguel, M.D., Ph.D., Hospital
Universitario de Salamanca
- Abstract #76: Oral presentation session: Sunday 9 December,
4:30 p.m.
-- VELCADE Dexamethasone (VEL/D) versus VAD as Induction Treatment Prior
to Autologous Stem Cell Transplantation (ASCT) in Newly Diagnosed
Multiple Myeloma
- Lead investigator: Jean-Luc Harousseau, M.D., University Hospital
Hotel-Dieu
- Abstract: #450: Oral presentation session: Monday 10 December,
1:30 p.m.
-- VELCADE, Thalidomide and Dexamethasone (VTD) versus Thalidomide
Dexamethasone (TD) in Preparation for Autologous Stem-Cell (SC)
Transplantation (ASCT) in Newly Diagnosed Multiple Myeloma
- Lead investigator: Michele Cavo, M.D., Seragnoli Institute of
Hematology, University of Bologna
- Abstract: #73: Oral presentation session: Sunday 9 December,
4:30 p.m.
Relapsed/Refractory Multiple Myeloma
Data will be presented from 23 studies of VELCADE based therapies for
the treatment of relapsed MM. These data, including settings where VELCADE
is used for retreatment and in patients with renal impairment, support the
importance of adding VELCADE in combination with numerous emerging and
established agents.
Non-Hodgkin's Lymphoma
VELCADE is the only approved therapy in previously treated mantle cell
lymphoma (MCL), the most aggressive form of NHL. Data will be featured on
VELCADE in various subsets of NHL, including follicular and the use of
biomarkers as a predictor of patient response.
About Multiple Myeloma
Multiple myeloma is the second most common hematologic malignancy and
although the disease is predominantly a cancer of the elderly (the median
age of onset is 70 years of age), recent statistics indicate both
increasing incidence and younger age of onset. In the U.S., more than
50,000 individuals have MM and 20,000 new cases are diagnosed each year.
Worldwide there are approximately 74,000 new cases and over 45,000 deaths
annually.
About Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma
NHL is the most common hematological cancer, the fifth leading cause of
cancer death and the second fastest growing form of cancer in the U.S. The
prevalence of NHL in the U.S. is approximately 400,000 patients, including
approximately 200,000 patients with diffuse large B-cell lymphoma, 100,000
patients with follicular and marginal zone lymphoma and 10,000 with MCL.
There are approximately 54,000 new cases of NHL diagnosed in the U.S. per
year, and 19,000 deaths are attributed to the disease annually.
MCL is an aggressive, rapidly progressive subtype of NHL, and is not
curable with standard treatment. The median life expectancy for a patient
with MCL following first relapse is one to two years.
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. are
co-promoting 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 of VELCADE as a Single-Agent: 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.
SOURCE Millennium Pharmaceuticals, Inc.
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CONTACT:
Media, Jennifer Snyder, +1-617-444-1439, or
Investors, Kyle Kuvalanka, +1-617-761-4734, both of Millennium
Pharmaceuticals, Inc.
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