- Millennium on track to file sNDA in first quarter 2008 -
CAMBRIDGE, Mass., Sept. 18 /PRNewswire-FirstCall/ -- Millennium
Pharmaceuticals, Inc. (Nasdaq: MLNM) today announced that the interim
analysis results of the large, international Phase III VISTA(1) trial in
patients with newly diagnosed multiple myeloma showed that the therapy of
VELCADE, melphalan and prednisone (VMP) demonstrated a highly statistically
significant improvement in all efficacy measures, including time-to-disease
progression, complete remission rate, progression-free survival and overall
survival, compared to melphalan and prednisone (MP) alone. Based on the
recommendation of an independent data monitoring committee (IDMC), which
conducted the planned interim, the control arm of the trial was stopped
early to allow patients still being treated with MP to have VELCADE added
to their therapy.
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"These results position VELCADE based therapy as a new standard of care
for newly diagnosed multiple myeloma patients," said Paul Richardson, M.D.,
Associate Professor of Medicine, Harvard Medical School; Clinical Director,
Jerome Lipper Multiple Myeloma Center Dana-Farber Cancer Institute Boston;
and a lead investigator of the VISTA trial. "The combination of VELCADE
with melphalan and prednisone surpassed all efficacy endpoints, including
time-to-disease progression, complete remission rate, progression-free
survival and overall survival, and did so, much earlier than expected. We
are excited at the possibility this new therapy could be available to our
patients sooner."
In the first quarter of 2008, the Company plans to file a supplemental
new drug application (sNDA) in the U.S. for use of VELCADE in patients with
newly diagnosed multiple myeloma, based on the data from this trial, which
was conducted under the special protocol assessment (SPA) process with the
Food and Drug Administration (FDA). The Company also expects that these
data will be presented at the December 2007 meeting of the American Society
of Hematology (ASH) in Atlanta, Georgia.
"An approval in front-line multiple myeloma would double the number of
patients eligible to receive the benefit of VELCADE," said Nancy Simonian,
M.D., Chief Medical Officer, Millennium. "We are confident that VELCADE
based therapies will become standard of care, since physicians typically
use the most active agents in the front-line setting to improve long-term
outcomes for patients."
The Phase III VISTA trial is being conducted by the Company and its
co-development partner Johnson & Johnson Pharmaceutical Research &
Development, L.L.C. (JJPRD). The trial randomized 682 patients with newly
diagnosed multiple myeloma, ineligible for stem cell transplantation, to
receive either VMP or MP, a recognized standard of care in this treatment
setting. Patients were enrolled at 151 clinical trial sites in 22
countries. The primary endpoint of the trial is time-to-disease progression
with secondary endpoints, including overall survival, progression-free
survival, complete remission rate and safety. Side effects of the VELCADE
based therapy were manageable and included those seen in previous VELCADE
clinical trials. Professor Jesus San Miguel, M.D., Hematology Department
Head, University Hospital of Salamanca, Spain, is the principal
investigator.
Conference Call Announcement
In conjunction with this news release, Millennium will host a webcast
today, Tuesday, September 18, 2007 at 8:00 A.M. ET. This webcast can be
accessed by visiting the Investors section of the Company's website,
http://www.millennium.com . Following the webcast, an archived version of
the call will be available at the same address for 30 days.
About Multiple Myeloma
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 20,000 new cases are diagnosed each year.
Worldwide there are approximately 74,000 new cases and over 45,000 deaths
annually.
About VELCADE
VELCADE is being co-developed by Millennium Pharmaceuticals, Inc. and
JJPRD. 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.
(1) VELCADE as Initial Standard Therapy in multiple myeloma: Assessment
with melphalan and prednisone
Contacts:
Jennifer Snyder (media) Kyle Kuvalanka (investors)
(617) 444-1439 (617) 761-4734
NOTE TO EDITORS: This press release is also available under the Media
section of the Company's website at: http://www.millennium.com
SOURCE Millennium Pharmaceuticals, Inc.
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Related links:
http://www.millennium.com
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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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