- Five Oral Presentations at ASCO Annual Meeting Will Further Demonstrate
the Strength of VELCADE Combinations in Front-line Multiple Myeloma -
CAMBRIDGE, Mass., May 16 /PRNewswire/ -- Millennium Pharmaceuticals,
The Takeda Oncology Company, today announced that new data from VELCADE
clinical studies are scheduled to be featured at the 2008 American Society
of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois, May 30 -
June 3, 2008. The data will highlight the significant efficacy of multiple
VELCADE based therapies in patients with newly diagnosed multiple myeloma
(MM).
(Logo: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO )
The Company submitted a supplemental New Drug Application (sNDA) to the
U.S. Food and Drug Administration (FDA) in December 2007 for the use of
VELCADE to treat patients with newly diagnosed MM. The filing is based on
data from the landmark Phase III VISTA trial. The FDA granted the sNDA
priority review and a decision is expected by June 20, 2008. VELCADE is
currently the market leader in relapsed multiple myeloma and the only drug
approved for the treatment of relapsed mantle cell lymphoma.
"VELCADE based therapies continue to demonstrate unprecedented complete
remission rates and survival benefits for patients with newly diagnosed
multiple myeloma," said Nancy Simonian, M.D., Chief Medical Officer,
Millennium. "Data to be presented at ASCO are expected to support that deep
and durable complete remissions are an important indicator for long-term
patient outcomes. The continued strength of clinical trial data, combined
with the pending FDA approval, will further solidify VELCADE as a key
component of the standard of care for this disease."
Newly Diagnosed Multiple Myeloma
Data to be featured at ASCO include the use of VELCADE in both newly
diagnosed transplant and non-transplant MM patients. The data from a total
of five studies (four Phase II and one Phase III) will highlight how
VELCADE based therapies consistently deliver high complete remission (CR)
rates and survival benefits to patients with newly diagnosed MM. Oral
presentation highlights are scheduled to include:
-- VELCADE Dexamethasone (Vc/D) versus VcAD as Induction Treatment Prior
to Autologous Stem Cell Transplantation (ASCT) in Previously Untreated
Multiple Myeloma: Updated Data from IFM 2005/01 Trial
-- Lead investigator: Jean-Luc Harousseau, M.D., Hospital Hotel-Dieu,
Nantes, France
-- Abstract #8505: Oral presentation session: Saturday, 31 May,
9:00 a.m. CT
-- Total Therapy (TT) for Myeloma: 10 Percent Cure Rate with TT1 Suggested
by >10 Year Continuous Complete Remission (CCR): VELCADE in TT3
Overcomes Poor Risk Associated with T (4;14) and DelTP53 in TT2
-- Lead investigator: Bart Barlogie, M.D., Ph.D., Director, Myeloma
Institute for Research and Therapy, University of Arkansas for
Medical Sciences
-- Abstract #8516: Oral presentation session: Saturday, 31 May,
3:00 p.m. CT
-- Efficacy of Induction with CyBorD in Newly Diagnosed Multiple Myeloma
-- Lead investigator: Craig Reeder, M.D., Assistant Professor of
Medicine - Mayo Clinic College of Medicine
-- Abstract #8517: Oral presentation session: Saturday, 31 May,
3:15 p.m. CT
-- VELCADE, Pegylated-Lyposomal-Doxorubicin and dexamethasone (PAD) as
Induction Therapy Prior to Reduced Intensity ASCT Followed by
Lenalidomide and Prednisone (LP) as Consolidation and Lenalidomide
Alone as Maintenance
-- Lead investigator: Antonio Palumbo, M.D., Chief of the Myeloma Unit;
Department of Hematology, University of Torino
-- Abstract #8518: Oral presentation session: Saturday, 31 May,
3:30 p.m. CT
-- Safety and Efficacy of Lenalidomide, VELCADE and dexamethasone in
Patients with Newly Diagnosed Multiple Myeloma: A Phase I/II Study
-- Lead investigator: Paul Richardson, M.D., Associate Professor of
Medicine, Harvard Medical School; Clinical Director, Jerome Lipper
Multiple Myeloma Center, Dana-Farber Cancer Institute, Boston
-- Abstract #8520: Oral presentation session: Saturday, 31 May,
4:15 p.m. CT
Relapsed/Refractory Multiple Myeloma
Data will be presented from several studies of VELCADE based therapies
for the treatment of relapsed MM. These data are expected to support the
value of adding VELCADE in combination with emerging and established
agents, including patients with renal insufficiency.
Non-Hodgkin's Lymphoma (NHL)
Beyond multiple myeloma, the Company continues to pursue and support
trials in NHL, which is expected to be the next potential growth
opportunity for VELCADE. Currently, VELCADE is the only approved therapy
for patients with previously treated mantle cell lymphoma (MCL), the most
aggressive form of NHL. ASCO-related data will be featured for VELCADE in
combination with established agents in patients with relapsed MCL, indolent
NHL and Waldenstrom's Macroglobulinemia, including:
-- Primary therapy of Waldenstrom's Macroglobulinemia with bortezomib,
dexamethasone and rituximab: results of WMCTG clinical trial 05-180
-- Lead investigator: Steven Treon, M.D., Ph.D., Assistant Professor in
Medicine, Harvard Medical School
-- Abstract #8519: Oral presentation session: Saturday, 31 May,
3:45 p.m. CT
In addition to these highlighted trials, the Company is expected to
fully accrue patients by the first half of this year for a large,
registration-enabling Phase III trial in follicular lymphoma. The trial is
designed under a special protocol assessment (SPA) with the FDA of VELCADE
and rituximab versus rituximab alone in patients with relapsed follicular
lymphoma. Final data are expected in 2010. These trials support the
Company's comprehensive development program in NHL.
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), 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 (NHL) and Mantle Cell Lymphoma (MCL)
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, The Takeda
Oncology Company, and Johnson & Johnson Pharmaceutical Research &
Development, L.L.C. Millennium is responsible for commercialization of
VELCADE in the U.S. and 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 85 countries worldwide. More than 85,000 patients
have been treated with VELCADE globally.
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
also 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 Reversible Posterior
Leukoencephalopathy Syndrome (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.
Integrated Safety Data: Safety data from Phase II and III studies of
single-agent VELCADE 1.3 mg/m2/dose twice weekly for 2 weeks followed by a
10-day rest period in 1163 patients with multiple myeloma (N=1008) and
mantle cell lymphoma (N=155) were integrated and tabulated. In these
studies, the safety profile of VELCADE was similar in patients with
multiple myeloma and mantle cell lymphoma. In the integrated analysis, the
most commonly reported adverse events were asthenic conditions (including
fatigue, malaise, and weakness) (64%), nausea (55%), diarrhea (52%),
constipation (41%), peripheral neuropathy NEC (including peripheral sensory
neuropathy and peripheral neuropathy aggravated) (39%), thrombocytopenia
and appetite decreased (including anorexia) (each 36%), pyrexia (34%),
vomiting (33%), and anemia (29%). Twenty percent (20%) of patients
experienced at least 1 episode of >/= Grade 4 toxicity, most commonly
thrombocytopenia (5%) and neutropenia (3%). A total of 50% of patients
experienced serious adverse events (SAEs) during the studies. The most
commonly reported SAEs included pneumonia (7%), pyrexia (6%), diarrhea
(5%), vomiting (4%), and nausea, dehydration, dyspnea and thrombocytopenia
(each 3%). Adverse events thought by the investigator to be drug-related
and leading to discontinuation occurred in 22% of patients. The reasons for
discontinuation included peripheral neuropathy (8%), asthenic conditions
(3%) and thrombocytopenia and diarrhea (each 2%). In total, 2% of the
patients died and the cause of death was considered by the investigator to
be possibly related to study drug: including reports of cardiac arrest,
congestive heart failure, respiratory failure, renal failure, pneumonia and
sepsis.
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, The Takeda Oncology Company, and 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 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.
Additional information about Millennium is available through its website,
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.
Editors' Note: This press release is also available under the Media
section of the Company's website at: http://www.millennium.com
Media Contacts:
Jennifer Snyder Karen Gobler
(617) 444-1439 (617) 444-1392
SOURCE Millennium Pharmaceuticals, Inc.
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http://www.millennium.com
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CONTACT:
Jennifer Snyder, +1-617-444-1439, or Karen
Gobler, +1-617-444-1392, both of Millennium Pharmaceuticals, Inc.
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