Publications Feature VELCADE(R) (Bortezomib) For Injection Strength In Hematological Cancers

Millennium
Pharmaceuticals, Inc. (Nasdaq: MLNM) today announced the publication of
clinical data of VELCADE in the treatment of newly diagnosed multiple
myeloma (MM), MM accompanied by advanced renal failure, and mantle cell
lymphoma (MCL). These data underscore the substantial activity and
well-characterized safety profile of VELCADE in the treatment of
hematological cancers.

“VELCADE, as a single agent and in combination, continues to be
differentiated by consistently demonstrating high response rates, including
complete responses, in a broad range of patients including those who until
now had limited treatment options,” says Bob Tepper, M.D., President,
Research and Development, Millennium. “Several recent publications have
highlighted this VELCADE strength. We continue to advance our Phase III
clinical and regulatory programs in front-line multiple myeloma and
non-Hodgkin’s lymphoma with the goal of rapidly bringing this novel therapy
to broader patient groups.”

VELCADE Combination Shows High Complete Response Rate in Newly
Diagnosed

Multiple Myeloma Patients

In the November 2006 issue of Haematologica Journal, results of a Phase
II study showed a complete response (CR) and near complete response (nCR)
rate of 21 percent after four cycles of induction therapy with VELCADE plus
dexamethasone. Along with a previously published study by Sundar Jagannath,
M.D., of St. Vincent’s Comprehensive Cancer Center, these data are among
the highest recorded CR/nCR rates for a dexamethasone-based therapy in the
treatment of front-line multiple myeloma. In previous clinical trials,
VELCADE in combination with other commonly used therapies has shown an
overall response rate (ORR) of up to 95 percent and a CR/nCR rate of up to
43 percent in the front-line MM setting.

The open-label, multicenter study conducted by Intergroupe Francophone
du Myelome (IFM) investigated the efficacy and safety of VELCADE in
combination with dexamethasone as induction therapy prior to stem cell
transplantation in 48 evaluable patients with newly diagnosed MM eligible
for stem cell transplantation. Patients who received the combination
achieved an ORR of 67 percent. In the 42 patients who went on to stem cell
collection, all patients were able to proceed to transplant. Therapy was
well tolerated. The most common side effects were gastrointestinal
symptoms, peripheral neuropathy and fatigue.

A Phase III registration-enabling study of VELCADE in combination with
dexamethasone compared to vincristine, doxorubicin, and dexamethasone
(VAD), a conventional induction therapy, is ongoing. Preliminary data from
this trial are expected to be presented by IFM at The American Society of
Hematology 48th Annual Meeting, December 9-12, 2006. This trial is part of
a broad Phase III program being conducted by Millennium and Johnson &
Johnson Pharmaceutical Research & Development, L.L.C. evaluating VELCADE in
the front-line multiple myeloma transplant and non-transplant treatment
settings.

VELCADE Based Therapies Show Benefits in Relapsed and / or Refractory

Multiple Myeloma Patients with Advanced Renal Failure Requiring
Dialysis

In the Blood First Edition Paper, prepublished online November 30,
2006, results of a retrospective analysis evaluating VELCADE therapies in
relapsed and / or refractory MM patients with advanced renal failure
demonstrated an ORR of 75 percent with a CR/nCR rate of 30 percent.
Approximately one-third of all MM patients experience some form of renal
impairment during the course of their disease which significantly impacts
prognosis and limits treatment options. The data from this analysis are
consistent with previous reports showing the efficacy and safety of VELCADE
in patients with impaired renal function and support the use of VELCADE
therapies in patients requiring dialysis.

The retrospective analysis included 20 evaluable MM patients requiring
dialysis for advanced renal failure. Twenty-nine percent of patients
received VELCADE in combination with liposomal doxorubicin and thalidomide
while the remaining received VELCADE either alone or as combination therapy
with dexamethasone, thalidomide, doxorubicin, cyclophosphamide and / or
prednisone. Patients stayed on treatment for a median of five cycles at the
standard VELCADE dose with a mean of seven cycles which is comparable to
the duration of treatment reported in MM patients with normal renal
function. Median duration of CR was 15 months while the median duration of
PR was 4.5 months. A total of four patients had improved renal function
following VELCADE based therapy, including one patient who was spared from
dialysis after rapid response to treatment and three other patients who
became independent of dialysis.

Treatment was well tolerated. Common adverse events were similar to
those seen in previous Phase II and III studies of patients with relapsed
and / or refractory MM.

VELCADE Shows High Level of Response in Treatment of Newly Diagnosed
and Previously Treated Mantle Cell Lymphoma Patients.

In the September 13, 2006 issue of Annals of Oncology, results of a
Phase II study of single-agent VELCADE showed an ORR of 46 percent in
patients with mantle cell lymphoma. Median response duration was 10 months.
The ORR for newly diagnosed patients was 46 percent, similar to that
observed in previously treated patients.

The response rate in previously treated patients support the results of
several published trials of VELCADE in relapsed mantle cell lymphoma,
including the multi-center, international PINNACLE study, the largest to
date in relapsed MCL. These trials showed that VELCADE as a single agent
had substantial activity with an ORR in the range of 30 to 40 percent and a
CR rate up to 21 percent. VELCADE is currently under Priority Review with
the U.S. Food and Drug Administration for relapsed mantle cell lymphoma. A
decision is expected by December 9, 2006. The significant response rate in
newly diagnosed patients is the first published data of VELCADE in this
setting and demonstrates the potential of VELCADE across all lines of
therapy in mantle cell lymphoma. Trials of VELCADE in combination are being
conducted by cooperative groups in newly diagnosed mantle cell lymphoma.

The study mentioned in this publication, conducted by the National
Cancer Institute of Canada Clinical Trials Group, enrolled 29 patients,
including 13 who had not received prior chemotherapy. Side effects included
neurological toxicity and myalgia.

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.(1)

About Non-Hodgkin’s Lymphoma and Mantle Cell Lymphoma

Non-Hodgkin’s lymphoma (NHL) is the most common hematological cancer,
the fifth leading cause of cancer death and the second fastest growing form
of cancer in the U.S.(2) The prevalence of NHL is approximately 400,000
patients, 77,000 patients with follicular lymphoma and 10,000 with mantle
cell lymphoma. There are approximately 54,000 new cases of NHL diagnosed
per year, and 19,000 deaths are attributed to the disease annually.(3,4)

Mantle cell lymphoma is an aggressive, rapidly progressive subtype of
NHL, and is not curable with standard treatment. Because there is no
generally accepted treatment approach and options often are limited, there
is a need for new therapies. The average life expectancy for a patient with
relapsed mantle cell lymphoma is one year.

About VELCADE

VELCADE is the market leader in relapsed multiple myeloma with over
44,000 patients treated worldwide, including clinical trials. VELCADE is
being co- developed by Millennium Pharmaceuticals, Inc. and Johnson &
Johnson Pharmaceutical Research & Development, L.L.C. (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. will
co-promote VELCADE in the U.S. VELCADE is approved in more than 75
countries worldwide. VELCADE also is approved in the European Union as a
treatment at first relapse.

VELCADE is indicated for the treatment of multiple myeloma patients 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.

In 331 patients who were treated with VELCADE in a Phase III study, the
most commonly reported adverse events were asthenic conditions (61
percent), diarrhea (57 percent), nausea (57 percent), constipation (42
percent), peripheral neuropathy (36 percent), vomiting (35 percent),
pyrexia (35 percent), thrombocytopenia (35 percent), psychiatric disorders
(35 percent), anorexia and appetite decreased (34 percent), parasthesia (27
percent), dysesthesia (27 percent), anemia and headache (26 percent), and
cough (21 percent). Fourteen percent of patients reported at least one
episode of grade 4 toxicity; the most common grade 4 toxicities were
thrombocytopenia (4 percent), neutropenia (2 percent), and hypercalcemia (2
percent). A total of 144 patients on VELCADE (44 percent) reported serious
adverse events (SAEs) during the study. The most commonly reported SAEs
were pyrexia (6 percent), diarrhea (5 percent), dyspnea and pneumonia (4
percent), and vomiting (3 percent).

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
millennium.

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. American Cancer Society, Overview: Multiple Myeloma, 2005,
cancer.

2. American Cancer Society, Inc., Surveillance Research, 2005.

3. SEER, SARGA, and Decision Resources (for growth rate) data.

4. Federico et al., BLOOD 95(3): 783-789; 2000.

Millennium Pharmaceuticals, Inc.
millennium

View drug information on Velcade.

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