Millennium Announces VELCADE(R) (Bortezomib) for Injection First-Quarter 2008 U.S....

Millennium Announces VELCADE(R) (Bortezomib) for Injection First-Quarter 2008
U.S. Net Sales
- 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 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 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 www.millennium.com.
Editors' Note: This press release is also available under the Media
section of the Company's website at: www.millennium.com.
Contacts:
Kyle Kuvalanka (investors) Karen Gobler (Media)
(617) 761-4734 (617) 444-1392

SOURCE Millennium Pharmaceuticals, Inc.

Investors, Kyle Kuvalanka, +1-617-761-4734; Media, Karen Gobler,
+1-617-444-1392, both for Millennium Pharmaceuticals, Inc.