- Two Scientific Pioneers Invest in Evolving Field of Protein Homeostasis -
CAMBRIDGE, Mass., Jan. 31 /PRNewswire-FirstCall/ -- Millennium
Pharmaceuticals, Inc. (Nasdaq: MLNM) and Harvard Medical School's Office of
Technology Development today announced an innovative collaboration
agreement to pursue a research program in the area of protein homeostasis,
an emerging and expanding field of cancer biology. Under the terms of the
agreement, Harvard has granted Millennium a license to certain invention
from the laboratory of Professor J. Wade Harper and the two institutions
will jointly advance the program in this novel area of research over
several years under a sponsored research agreement. Financial terms were
not disclosed.
(Logo: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO )
"Harvard Medical School's research initiatives in protein homeostasis,
together with the demonstrated leadership of Millennium in this area,
promises to advance our understanding of this important field and its role
in regulating cancer cells," said Wade Harper, Ph.D., Bert and Natalie
Vallee Professor of Molecular Pathology, Harvard Medical School. "We expect
this collaboration to accelerate the important work the lab has
accomplished to date."
Research has shown various pathways that regulate cellular protein
homeostasis are linked to the pathologic properties of a broad range of
cancers. The initial research-based agreement is focused on advancing
knowledge in this evolving field over the course of three years.
"Wade Harper's ground-breaking scientific progress in the field of
protein homeostasis makes this agreement a natural fit for our Discovery
organization," said Joe Bolen, Ph.D., Chief Scientific Officer, Millennium.
"Our mutual interest in advancing this promising area of research will
provide the opportunity to apply our combined knowledge and expertise and
may ultimately lead to a new generation of therapies for patients."
The collaboration further underscores the significant expertise in, and
commitment to the field of protein homeostasis at Millennium. VELCADE(R)
(bortezomib) for Injection, the market leader for multiple myeloma and
mantle cell lymphoma patients, who have received at least one prior
therapy, is the first and only marketed proteasome inhibitor. In addition,
the Company recently advanced two novel molecules into development that
regulate protein homeostasis. MLN4924 is an inhibitor of the Millennium
discovered Nedd 8 activating enzyme. MLN4924 acts by inhibiting Cullin
based ligases, enzymes involved in the regulation of cancer cell growth and
survival. This molecule is expected to enter Phase I clinical trials in
early 2008. MLN2238, a second generation proteasome inhibitor, recently was
advanced to the development pipeline. MLN2238 has demonstrated impressive
properties in preclinical studies that distinguish it from current
proteasome inhibitors. This molecule is being developed for both oral and
IV routes of administration thereby expanding the potential clinical
utility of proteasome inhibitors.
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 research,
development and commercialization activities of Millennium 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 Millennium Web site is
http://www.millennium.com.
About Harvard University's Office of Technology Development
The Harvard Office of Technology Development (OTD) is responsible for
all activities pertaining to the evaluation, patenting and licensing of new
inventions and discoveries made at Harvard University and Harvard Medical
School. OTD also serves to further the development of Harvard technologies
through the establishment of sponsored research collaborations with
industry. OTD's mission is to promote the public good by fostering
innovation and translating new inventions made at Harvard into useful
products available and beneficial to society.
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. currently
co-promote 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
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 2 and 3 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. This integrated analysis does not include the phase 3, VELCADE plus
DOXIL study.
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).
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.
Contacts:
Jennifer Snyder (media) Kyle Kuvalanka (investors)
(617) 444-1439 (617) 761-4734
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
http://www.prnewswire.com/comp/114562.html/
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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