-- More than 70 abstracts highlight VELCADE efficacy in broad range of
patients and across continuum of care --
CAMBRIDGE, Mass., June 19 /PRNewswire-FirstCall/ -- Millennium
Pharmaceuticals, Inc. (Nasdaq: MLNM) today announced that data for VELCADE,
the market leading therapy with unsurpassed single-agent efficacy for
patients with previously treated multiple myeloma (MM), will be featured at
the upcoming International Myeloma Workshop (IMW) in Kos, Greece, June
25-30, 2007.
(Logo: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO )
"Clinical data to be presented next week will underscore the crucial
role of VELCADE based therapies in the front-line multiple myeloma
treatment setting. These results will show that the high complete response
rates seen with VELCADE based combinations translate to some of the most
impressive survival rates to date," said Deborah Dunsire, M.D., President
and Chief Executive Officer, Millennium. "These are exciting data for the
field of multiple myeloma as we see that combining the power of VELCADE
with other active agents substantially prolonged the lives of patients."
VELCADE in Front-Line MM Patients
Previously presented data have shown that VELCADE based combinations
produce very high complete and near complete response rates. Data presented
at this conference are expected to provide further evidence that this
benefit leads to prolonged survival. Abstract highlights include:
-- Phase I / II Study of Upfront VELCADE, Lenalidomide and Dexamethasone
in Multiple Myeloma: Early Results
* Lead investigator: Paul Richardson, M.D., Dana-Farber Cancer
Institute
* Abstract #715; Poster session: Thursday 28th June, 4:30 p.m.
-- Front-line VELCADE, Melphalan and Prednisone (VMP) in Elderly Multiple
Myeloma Patients: Extended Follow-Up
* Lead investigator: Maria-Victoria Mateos, M.D., PhD., Grupo Espanol
de Multiple Myeloma
* Abstract #718; Poster session: Thursday 28th June, 4:30 p.m.
-- Combination Therapy with VELCADE, DOXIL(R) (pegylated liposomal
doxorubicin) and Dexamethasone (VDD) in Newly Diagnosed Myeloma:
Updated Results of a Phase II Clinical Trial
* Lead investigator: Andrzej Jakubowiak, M.D., PhD., University of
Michigan Comprehensive Cancer Center
* Abstract #721; Poster session: Thursday 28th June, 4:30 p.m.
-- Long-term Follow-Up of VELCADE, Doxorubicin and Dexamethasone (referred
to as VcAD or PAD) for Untreated Multiple Myeloma
* Lead investigator: Rakesh Popat, M.D., St. Bartholomew's Hospital
Abstract #725; Poster session: Thursday 28th June, 4:30 p.m.
VELCADE in Previously Treated MM Patients
Data are expected to further support VELCADE as a foundation for
combination therapy showing very high complete response rates in both
VELCADE naive and retreated patients. Abstract highlights include:
-- Weekly VELCADE, Cyclophosphamide and Prednisone in Myeloma
* Lead investigator: Donna Reece, M.D., Princess Margaret Hospital
* Abstract #639; Poster session: Thursday 28th June, 4:30 p.m.
-- Phase II Study of VELCADE, Lenalidomide and Dexamethasone in Relapsed /
Refractory Multiple Myeloma
* Lead investigator: Paul Richardson, M.D., Dana-Farber Cancer
Institute
* Abstract #660; Poster session: Thursday 28th June, 4:30 p.m.
VELCADE Addresses Multiple Myeloma-Related Complications
New data are expected to show that VELCADE is active and safe in
patients with renal impairment and bone degeneration. These data will
demonstrate VELCADE differentiation in benefiting a broad range of
patients. Abstract highlights include:
-- VELCADE Plus Dexamethasone Therapy Induces Osteoblast Activation in
Responsive Patients with Multiple Myeloma
* Lead investigator: Shuji Ozaki, M.D., The University of Tokushima
Graduate School of Health Biosciences
* Abstract #311; Poster session: Tuesday 26th June, 4:30 p.m.
-- Effect of VELCADE Monotherapy and VELCADE Based Regimens on Bone
Metabolism in Patients with Relapsed / Refractory Multiple Myeloma
* Lead investigator: Evangelos Terpos, M.D., General Airforce
Hospital
* Abstract #320; Poster session: Tuesday 26th June, 4:30 p.m.
-- Cystatin-C: An Early Marker of Renal Impairment and an Independent
Predictive Factor for Survival in Multiple Myeloma. Reduction Post
VELCADE Therapy
* Lead investigator: Evangelos Terpos, M.D., General Airforce
Hospital
* Abstract #227; Poster session: Tuesday 26th June, 4:30 p.m.
-- VELCADE in Renally Impaired Multiple Myeloma Patients
* Lead investigator: Jesus San Miguel, M.D., PhD., Hospital
Universitario de Salamanca
* Abstract #1114; Poster session: Thursday 28th June, 4:30 p.m.
VELCADE Shows Potential in Additional Diseases and in Combination with
Emerging Agents
New data will highlight VELCADE efficacy in amyloidosis, a disease of
high unmet need, and in combination with new agents such as HSP90-, AKT-
and mTOR-inhibitors. Abstract highlights include:
-- Treatment of Light Chain (AL) Amyloidosis with the Combination of
VELCADE and Dexamethasone
* Lead investigator: Efstathios Kastritis, M.D., Alexandra Hospital,
University of Athens School of Medicine
* Abstract #913; Poster session: Thursday 28th June, 4:30 p.m.
-- VELCADE and Tanespimycin in Multiple Myeloma: Pharmacology, Safety and
Activity in Relapsed / Refractory Patients
* Lead investigator: Paul Richardson, M.D., Dana-Farber Cancer
Institute
* Abstract #610; Poster session: Thursday 28th June, 4:30 p.m.
-- A Multicenter Phase I / II Trial of VELCADE and Perifosine (KRX-0401)
in Relapsed / Refractory Multiple Myeloma Patients Previously Treated
with VELCADE: Preliminary Results
* Lead investigator: Paul Richardson, M.D., Dana-Farber Cancer
Institute
* Abstract #608; Poster session: Thursday 28th June, 4:30 p.m.
-- Combination of the mTOR-Inhibitor Rapamycin and Proteasome Inhibitor
VELCADE is Synergistic In Vitro in Multiple Myeloma
* Lead investigator: Xavier Leleu, M.D., Centre Hospitalier Regional
Universitaire de Lille
* Abstract #534; Poster session: Tuesday 26th June, 4:30 p.m.
About Multiple Myeloma (MM)
Multiple myeloma is the second most common hematologic malignancy and
although the disease is predominantly a cancer of the elderly (the average
age of onset is 65 to 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 close to 20,000 new cases are diagnosed each
year. Worldwide there are approximately 74,000 new cases and more than
45,000 deaths annually.
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, 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%) in single-agent VELCADE, 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.
Editors' Note: This press release is also available under the Media
section of the Company's website at: http://www.millennium.com. All session times
listed are Eastern European Daylight Time.
SOURCE Millennium Pharmaceuticals, Inc.
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