- Strong U.S. sales growth to $83.5 million, up 13 percent over
fourth-quarter 2007 and 42 percent over first-quarter 2007 -
CAMBRIDGE, Mass., April 10 /PRNewswire-FirstCall/ -- Millennium
Pharmaceuticals, Inc. (Nasdaq: MLNM) today announced first-quarter 2008
U.S. net sales of $83.5 million for its flagship product VELCADE, the
global market leader for the treatment of patients with relapsed multiple
myeloma. These results represent a 13 percent increase over fourth-quarter
2007 and a 42 percent increase over the first-quarter 2007, significantly
exceeding the U.S. Wall Street analyst consensus estimate.
(Logo: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO )
"VELCADE sales continue to strengthen, driven primarily by greater use
in patients with relapsed multiple myeloma," said Deborah Dunsire, M.D.,
President and Chief Executive Officer, Millennium. "We expect to see
further sales acceleration should the FDA approve VELCADE for, and after we
begin to promote for use in patients with, newly diagnosed multiple
myeloma. The FDA decision date is June 20, 2008. We believe an approval
could potentially double the number of patients with multiple myeloma
eligible to benefit from VELCADE."
About VELCADE
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. and
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. are co-promoting VELCADE in the U.S. VELCADE is approved
in over 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
also 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 greater than or equal to 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).
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. Millennium'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. Millennium's website is http://www.millennium.com.
Millennium has announced that it has entered into an Agreement and Plan of
Merger, dated as of April 10, 2008, with Takeda America Holdings, Inc., a
New York corporation ("Takeda"), and Mahogany Acquisition Corp., a Delaware
corporation and a wholly-owned subsidiary of Takeda ("Merger Sub"),
pursuant to which Merger Sub will make a cash tender offer (the "Offer") to
purchase all of the issued and outstanding shares of Millennium common
stock, and Millennium will become a wholly-owned subsidiary of Takeda.
Use of Forward-Looking Statements
This material contains "forward-looking statements" that involve
significant risks and uncertainties. All statements other than statements
of historical fact are statements that could be deemed forward-looking
statements, including: statements regarding the Company's growth, future
operating results, discovery, development of products and strategic
alliances; statements regarding the potential number of patients eligible
to benefit from VELCADE; statements regarding the merger agreement between
Millennium and Takeda; any statements of expectation or belief; and any
statements of assumptions underlying any of the foregoing. Employees,
investors and security holders are cautioned not to place undue reliance on
these forward-looking statements. Actual results could differ materially
from those currently anticipated due to a number of risks and
uncertainties. Risks and uncertainties that could cause Millennium's
results to differ from expectations include: 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; Millennium'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 Millennium's products; government and third-party
reimbursement rates; the commercial success of VELCADE and INTEGRILIN(R)
(eptifibatide) Injection; achieving revenue consistent with internal
forecasts; the requirement for substantial funding to conduct research and
development and to expand commercialization activities; uncertainties as to
the timing of the transactions contemplated by the merger agreement;
uncertainties as to how many of the Millennium's stockholders will tender
their stock in the Offer; the risk that competing offers will be made; the
possibility that various closing conditions for the transactions
contemplated by the merger agreement may not be satisfied or waived,
including that a governmental entity may prohibit, delay or refuse to grant
approval for the consummation of the transactions; the effects of
disruption from the transactions making it more difficult to maintain
relationships with employees, licensees, other business partners or
governmental entities; other business effects, including the effects of
industry, economic or political conditions outside of Millennium's or
Takeda's control; transaction costs; actual or contingent liabilities; and
other risks and uncertainties discussed in documents filed with the U.S.
Securities and Exchange Commission by Millennium, as well as the tender
offer documents to be filed by Merger Sub and Takeda and the
Solicitation/Recommendation Statement to be filed by Millennium. Neither
Millennium, Takeda nor Merger Sub undertakes any obligation to update any
forward-looking statements as a result of new information, future
developments or otherwise.
Additional Information and Where to Find It
The tender offer for the outstanding common stock of Millennium
referred to in this material has not yet commenced. This material is
neither an offer to purchase nor a solicitation of an offer to sell any
securities. The solicitation and the offer to buy shares of Millennium's
common stock will be made pursuant to an offer to purchase and related
materials that Takeda intends to file with the U.S. Securities and Exchange
Commission. At the time the tender offer is commenced, Takeda will file a
Tender Offer Statement on Schedule TO with the U.S. Securities and Exchange
Commission, and thereafter Millennium will file a
Solicitation/Recommendation Statement on Schedule 14D-9 with respect to the
tender offer. THE TENDER OFFER STATEMENT (INCLUDING AN OFFER TO PURCHASE, A
RELATED LETTER OF TRANSMITTAL AND OTHER OFFER DOCUMENTS) AND THE
SOLICITATION/RECOMMENDATION STATEMENT WILL CONTAIN IMPORTANT INFORMATION
THAT SHOULD BE READ CAREFULLY AND CONSIDERED BEFORE ANY DECISION IS MADE
WITH RESPECT TO THE TENDER OFFER. These materials will be sent free of
charge to all stockholders of Millennium. In addition, all of these
materials (and all other materials filed by Millennium with the U.S.
Securities and Exchange Commission) will be available at no charge from the
U.S. Securities and Exchange Commission through its website at http://www.sec.gov.
Investors and security holders may also obtain free copies of the documents
filed with the U.S. Securities and Exchange Commission by Millennium at
http://www.millennium.com.
Editors' Note: This press release is also available under the Media
section of the Company's website at: http://www.millennium.com.
Contacts:
Kyle Kuvalanka (investors) Karen Gobler (Media)
(617) 761-4734 (617) 444-1392
SOURCE Millennium Pharmaceuticals, Inc.
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Related links:
http://www.millennium.com
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PRN Photo Desk, photodesk@prnewswire.com
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CONTACT:
Investors, Kyle Kuvalanka, +1-617-761-4734;
Media, Karen Gobler, +1-617-444-1392, both for Millennium
Pharmaceuticals, Inc.
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