CAMBRIDGE, Mass., Dec. 12 /PRNewswire-FirstCall/ -- Millennium
Pharmaceuticals, Inc. (Nasdaq: MLNM) today announced that VELCADE(R)
(bortezomib) for Injection, the only single agent to demonstrate a survival
benefit in patients with relapsed multiple myeloma (MM), has been added to
the updated National Comprehensive Cancer Network (NCCN) treatment protocol
for newly diagnosed MM patients. These practice guidelines are a benchmark
for clinical policy in the oncology community. The guidelines are updated
continually in a process with explicit review of the evidence by
multidisciplinary panels of expert physicians from NCCN member
institutions. NCCN has posted the updated information to their website at
http://www.nccn.org.
(Logo: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO )
"A major addition to the guidance is the inclusion of bortezomib as
front-line therapy for multiple myeloma, an addition based on data from 12
Phase II clinical trials in more than 600 patients," said Kenneth C.
Anderson, M.D., Kraft Family Professor of Medicine, Harvard Medical School,
Dana-Farber Cancer Institute and NCCN Multiple Myeloma Cancer Guidelines
Panel Chair.
"The inclusion of VELCADE in the NCCN guidelines is critical to helping
improve the outcomes of newly diagnosed patients," said Nancy Simonian,
M.D., Senior Vice President and Chief Medical Officer, Millennium. "The
complete response rates we've seen in emerging data thus far with VELCADE
in the front-line multiple myeloma setting and our three, large,
registration-enabling Phase III studies currently ongoing in this treatment
setting, add to the growing data supporting VELCADE as the backbone of
therapy in all lines of therapy."
VELCADE is approved by the Food and Drug Administration for the
treatment of MM patients who have received at least one prior therapy. It
is the market leader in the U.S. with over 50,000 patients treated
worldwide and the only single agent with an unmatched median survival of
29.8 months in patients who have received one to three prior therapies. The
Company, together with co-development partner Johnson & Johnson
Pharmaceutical Research & Development, L.L.C., currently has three, large
international Phase III trials underway evaluating VELCADE based
combinations in newly diagnosed patients. Collectively, these studies are
anticipated to enroll approximately 2,000 patients.
The NCCN guidelines are distributed free of charge to clinical
professionals in the United States and internationally. User-friendly
patient versions of NCCN guidelines are available to patients and their
families. For more information, call the NCCN at (215) 690-0300 or visit
http://www.nccn.org.
About Multiple Myeloma
MM 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 over 15,000 new cases are diagnosed each year.
Worldwide there are approximately 74,000 new cases and over 45,000 deaths
annually.(1)
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.
Editors' Note: This press release is also available under the Media
section of the Company's website at: http://www.millennium.com.
1. American Cancer Society, Overview: Multiple Myeloma, 2005,
http://www.cancer.org
Contacts:
Jennifer Snyder (media) Kyle Kuvalanka (investors)
(617) 448-0281 (857) 498-0818
SOURCE Millennium Pharmaceuticals, Inc.
 back to top
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:
Jennifer Snyder, +1-617-448-0281, or Kyle
Kuvalanka, +1-857-498- 0818, both of Millennium Pharmaceuticals
|
