- Findings Published in Blood Highlight Millennium Leadership in
Personalized Medicine and Could Strengthen the Role of VELCADE as
Foundation of Therapy in Broad Range of Multiple Myeloma Patients -
CAMBRIDGE, Mass., April 17 /PRNewswire-FirstCall/ -- Findings published
in the April 15th issue of Blood show that a team of researchers led by
Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM) has discovered biomarkers
which may lead to identifying multiple myeloma patients likely to respond
to VELCADE. VELCADE is the U.S. market leading therapy for previously
treated multiple myeloma patients with an unsurpassed median survival of
29.8 months as a single agent.
These findings add to the body of evidence that supports the role of
VELCADE in the treatment of a broad range of multiple myeloma patients and
highlight the applicability of genomics research. This research, in
combination with similar ongoing studies, may ultimately lead to improved
outcomes for patients.
The identification of these biomarkers was the result of a
collaborative effort by researchers from Millennium and leading multiple
myeloma academic centers. These centers included Dana-Farber Cancer
Institute, Boston; Myeloma Institute of Research and Therapy at the
University of Arkansas for Medical Services, Little Rock; Mayo Clinic,
Scottsdale; and Department of Hematology, Erasmus Medical Center,
Rotterdam.
The combined team performed genomics analyses on tumor samples from
multiple myeloma patients in VELCADE clinical trials. These trials included
the APEX Phase III study, which demonstrated the superiority of VELCADE
over standard-of-care dexamethasone in previously treated multiple myeloma
patients and is one of the first and largest prospective randomized trials
to include genomics analyses.
Findings from the analyses showed that patients with an increased
expression of genes in the NFk-B and adhesion molecule pathways may be more
sensitive to VELCADE therapy. Additionally, these findings showed that the
biomarkers did not predict sensitivity to dexamethasone therapy, indicating
that the biomarkers may be specific to VELCADE.
"Millennium is recognized as a leader in personalized medicine, and
this publication is a testament to the strength of our clinical
innovation," said Nancy Simonian, M.D., Chief Medical Officer, Millennium.
"The genomic findings add further knowledge about VELCADE efficacy in
treating a broad range of multiple myeloma patients."
Millennium and its co-development partner, Johnson & Johnson
Pharmaceutical Research and Development, L.L.C. (J&JPRD) is continuing
genomics research on VELCADE in additional trials. Studies include a Phase
III trial conducted by the Dutch and German co-operative groups, HOVON and
GMMG, which is evaluating a VELCADE based combination in patients with
newly diagnosed multiple myeloma. In addition, genomics research is ongoing
in a Phase III trial evaluating a VELCADE based combination therapy in
indolent non-Hodgkin's lymphoma.
"While the published results represent an important step forward in our
genomics research, the next critical step is to conduct similar analyses
with VELCADE in combination with other anti-cancer agents," said George
Mulligan PhD, Associate Director, Translational Medicine, Millennium. "We
are committed to improving outcomes for multiple myeloma patients and this
work should bring us closer to determining optimal treatment strategies."
About VELCADE
VELCADE is being co-developed by Millennium and J&JPRD. 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, 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%), 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
nine 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 research 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.
Contacts:
Kyle Kuvalanka (investors) Jennifer Snyder (media)
(617) 761-4734 (617) 444-1439
(Logo: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO )
SOURCE Millennium Pharmaceuticals, Inc.
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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
CONTACT:
Investors: Kyle Kuvalanka, +1-617-761-4734,
or Media: Jennifer Snyder, +1-617-444-1439, both of Millennium
Pharmaceuticals, Inc.
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