Millennium Announces VELCADE(R) (bortezomib) for Injection has Significantly Extended Survival in Phase III (APEX) Trial of Patients with Relapsed Multiple Myeloma -- Results to be presented at upcoming ASCO meeting --
Ergebnisse werden im Asco meeting vorgestellt!
CAMBRIDGE, Mass., May 17, 2004 /PRNewswire-FirstCall via COMTEX/ -- Millennium
Pharmaceuticals, Inc. (Nasdaq: MLNM) today announced that in the final survival
endpoint analysis in the phase III confirmatory APEX study comparing patients
receiving VELCADE to those receiving high-dose dexamethasone, VELCADE produced a
statistically significant survival benefit. The study was designed to include
survival as a secondary endpoint and allowed crossover for patients experiencing
disease progression on high-dose dexamethasone to receive VELCADE. Both the
interim data and the final survival analysis from the APEX study will be
presented on Sunday, June 6, 2004 at the upcoming American Society of Clinical
Oncology (ASCO) meeting in New Orleans, LA.
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"We are extremely pleased and enthusiastic about the clear survival advantage
demonstrated in this trial," said David Schenkein, M.D., vice president,
clinical oncology development, Millennium. "This is the first randomized study
of a treatment in the relapsed multiple myeloma setting to show a survival
advantage over a current standard of care. Further, these data potentially
represent a significant opportunity to make an important difference in extending
survival for patients living with multiple myeloma."
The confirmatory phase III APEX trial included patients with relapsed or
refractory multiple myeloma whose disease had progressed after receiving one to
three previous therapies. The study was halted one year early in December of
2003 after a data monitoring committee concluded the findings of a pre-
specified interim analysis showed a statistically significant improvement in
time to disease progression -- the primary endpoint of the trial -- in patients
receiving VELCADE compared to patients receiving high-dose dexamethasone.
Patients were randomized to receive either VELCADE or high- dose dexamethasone,
a recognized standard of care in this setting. The trial enrolled more than 670
patients in 95 sites in the United States, Canada and Europe. The trial design
included a primary endpoint of time to disease progression and secondary
endpoints that included measurements of clinical benefit, safety and survival.
About VELCADE(R) (bortezomib) for Injection
VELCADE, the first of a new class of medicines called proteasome inhibitors, is
the first treatment in more than a decade to be approved for patients with
multiple myeloma -- a cancer of the blood. Millennium received approval from the
U.S. Food and Drug Administration (FDA) on May 13, 2003 to market VELCADE for
the treatment of multiple myeloma patients who have received at least two prior
therapies and have demonstrated disease progression on the last therapy. The
effectiveness of VELCADE is based on response rates. There are no controlled
trials demonstrating a clinical benefit such as an improvement in survival. On
April, 27, 2004, the European Commission granted marketing authorization for
VELCADE for the treatment of patients with multiple myeloma who have received at
least two prior therapies and have demonstrated disease progression on their
last therapy.
VELCADE is being co-developed by Millennium and Johnson & Johnson Pharmaceutical
Research & Development; Millennium is responsible for commercialization of
VELCADE in the U.S.; Ortho Biotech and Janssen-Cilag will be responsible for
commercialization in Europe and the rest of the world. Janssen Pharmaceutical
K.K. will be responsible for Japan.
VELCADE has a generally predictable, manageable safety profile (with appropriate
monitoring and, if necessary, dose modification). VELCADE is contraindicated in
patients with hypersensitivity to bortezomib, boron, or mannitol.
Risks associated with VELCADE therapy include new or worsening peripheral
neuropathy, orthostatic hypotension, congestive heart failure, gastrointestinal
adverse events, thrombocytopenia, and tumor lysis syndrome. Women of
childbearing potential should avoid becoming pregnant while being treated with
VELCADE.
In 228 patients who were treated with VELCADE(R) (bortezomib) 1.3 mg/m2/dose in
phase II studies, the most commonly reported adverse events were asthenic
conditions (65 percent), nausea (64 percent), diarrhea (51 percent), decreased
appetite including anorexia (43 percent), constipation (43 percent),
thrombocytopenia (43 percent), peripheral neuropathy (37 percent), pyrexia (36
percent), vomiting (36 percent), and anemia (32 percent). Fourteen percent of
patients experienced at least one episode of Grade 4 toxicity, with the most
common toxicities being thrombocytopenia (3 percent) and neutropenia (3
percent). A total of 113 (50 percent) of the 228 patients experienced Serious
Adverse Events (SAEs) during studies. The most commonly reported SAEs included
pyrexia (7 percent), pneumonia (7 percent), diarrhea (6 percent), vomiting (5
percent), dehydration (5 percent), and nausea (4 percent).
For more information about VELCADE clinical trials, patients and physicians can
contact the Millennium Medical Product Information Department at
1-(866)-VELCADE.
About Millennium
Millennium Pharmaceuticals, Inc., a leading biopharmaceutical company based in
Cambridge, Mass., markets VELCADE(R) (bortezomib) for Injection, a novel cancer
product, co-promotes INTEGRILIN(R) (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 our growth and future operating results, discovery and development of
products, potential acquisitions, strategic alliances and intellectual property.
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 our drug discovery and clinical development
programs; failure to obtain patent protection for our discoveries; commercial
limitations imposed by patents owned or controlled by third parties; our
dependence upon strategic alliance partners to develop and commercialize
products and services based on our work; difficulties or delays in obtaining
regulatory approvals to market products and services resulting from our
development efforts; the commercial success of INTEGRILIN and VELCADE; 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 we face, see the reports we have filed with the
Securities and Exchange Commission. We disclaim any intention or obligation to
update or revise any forward-looking statements, whether as a result of new
information, future events or otherwise.
Editor's Note: This release is available under the Media section on the
Company's website at www.millennium.com.
Contacts:
Kelly Lindenboom (media) Cynthia Clayton (investor)
(617) 679-7405 (617) 551-8607
SOURCE Millennium Pharmaceuticals, Inc.
CONTACT: Kelly Lindenboom (media), +1-617-679-7405, or Cynthia Clayton
(investor), +1-617-551-8607 both of Millennium Pharmaceuticals, Inc.
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