Company-sponsored trial in patients with either brochioloalveolar carcinoma
(BAC) or adenocarcinoma with BAC features reinforces commitment to strategic
CAMBRIDGE, Mass., April 25, 2005 /PRNewswire-FirstCall/ -- Millennium
Pharmaceuticals, Inc. (Nasdaq: MLNM) today announced, in collaboration with
Johnson & Johnson Pharmaceutical Research & Development, LLC, the initiation
of PEAK (Prospective Evaluation of bortezomib in Adenocarcinoma with
bronchioalveolar features as a Keystone of therapy). This is a multicenter
phase II clinical trial of VELCADE in patients with either advanced BAC or
adenocarcinoma with BAC features that have progressed on or after receiving
one to two lines of chemotherapy, one of which must have been an epidermal
growth factor receptor tyrosine kinase inhibitor (EGRF TKI). The open-label
study will assess efficacy in terms of tumor response rate measured by
Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.
"Millennium, and our partner Johnson and Johnson, are committed to
investigating VELCADE as a therapy for lung cancer and this trial is an
integral component of our global development plan," said David Schenkein,
M.D., senior vice president, clinical research, Millennium. "In reviewing
previous VELCADE experiences, we saw several dramatic single-agent responses
in patients with BAC and we are eager to explore the potential of VELCADE so
that we may be able to offer new options for patients in need."
VELCADE is approved in the U.S. for the treatment of patients who have
received at least one prior therapy. Millennium and Johnson & Johnson continue
to investigate VELCADE globally in phase I, II and III clinical trials in both
hematologic and solid tumors, including frontline MM, non-Hodgkin's lymphoma
and lung, prostate and ovarian cancers.
Patients with BAC or adenocarcinoma with BAC features comprise a 30,000-
patient group representing approximately 20% of the overall non-small cell
lung population. These patients tend to have a unique histology and have
typically responded poorly to cytotoxic drugs used for non-small cell lung
cancer. Data suggest that the incidence of BAC is increasing, notably in
younger non-smoking women. Despite reports of prolonged survival, BAC remains
incurable with the vast majority of patients dying of respiratory failure or
pneumonia within five years of diagnosis.
About VELCADE® (bortezomib) for Injection
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.
Risks associated with VELCADE therapy include new or worsening peripheral
neuropathy, hypotension, cardiac disorders, gastrointestinal adverse events,
thrombocytopenia 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 1.3 mg/m2 dose in the phase
III APEX study, the most commonly reported adverse events were asthenic
conditions (61%), diarrhea (57%), nausea (57%), constipation (42%), peripheral
neuropathy (36%), vomiting (35%), pyrexia (35%), thrombocytopenia (35%),
psychiatric disorders (35%) and anorexia and appetite decreased (34%).
Fourteen percent of patients reported at least one episode of grade 4
toxicity; the most common grade 4 toxicities were thrombocytopenia (4%),
neutropenia (2%) and hypercalcemia (2%). A total of 144 patients on VELCADE
(44%) reported serious adverse events (SAEs) during the study. The most
commonly reported SAEs were pyrexia (6%), diarrhea (5%), dyspnea and pneumonia
(4%) and vomiting (3%).
VELCADE is being co-developed by Millennium and Johnson & Johnson
Pharmaceutical Research & Development, L.L.C. Millennium is responsible for
commercialization of VELCADE in the U.S.; Ortho Biotech and Janssen-Cilag are
responsible for commercialization in Europe and the rest of the world. Janssen
Pharmaceutical K.K. is responsible for Japan. VELCADE is approved in more than
40 countries worldwide including the U.S., European Union members, and a
number of countries within Latin America and South-East Asia such as
Argentina, China, Korea, Singapore and Thailand.
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).
Millennium Pharmaceuticals, Inc., a leading biopharmaceutical company
based in Cambridge, Mass., markets VELCADE, a novel cancer product, co-
promotes INTEGRILIN® (eptifibatide) Injection, a market-leading
cardiovascular product, and has a robust clinical development pipeline of
product candidates. The Company's research, development and commercialization
activities are focused in three therapeutic areas: oncology, cardiovascular,
and inflammation. By applying its knowledge of the human genome, its
understanding of disease mechanisms, and its industrialized drug discovery
platform, Millennium is seeking to develop breakthrough products.
This press release contains "forward-looking statements," including
statements about the Company's discovery 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® (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
Editors' Note: This press release is also available under the Media
section of the Company's website at: http://www.millennium.com.
Both of Millennium Pharmaceuticals