- 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.
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"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 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: www.millennium.com.
SOURCE Millennium Pharmaceuticals, Inc.
CONTACT: Media, Jennifer Snyder, +1-617-444-1439, or Investors, Kyle
Kuvalanka, +1-617-761-4734, both of Millennium Pharmaceuticals, Inc./
