Millennium Agrees to Acquire AnorMED, Adding Phase III Oncology Product with Planned Near Term Launch Date
September 26 2006 - 10:46AM
PR Newswire (US)
Phase III MOZOBIL complements Millennium's market-leading VELCADE
and enhances patient eligibility for potentially life-saving stem
cell transplants CAMBRIDGE, Mass., Sept. 26 /PRNewswire-FirstCall/
-- Millennium Pharmaceuticals, Inc. (NASDAQ:MLNM) today announced
it has entered into an agreement to acquire AnorMED, Inc. (Nasdaq:
ANOR; TSX: AOM), a Canadian-based biopharmaceutical company with a
late-stage Phase III hematology-oncology product, MOZOBIL. Under
the terms of the agreement approved by the boards of directors of
both companies and the largest shareholder of AnorMED, Millennium
will commence within ten days a cash tender offer to acquire the
shares of AnorMED stock at a price of U.S. $12.00 per outstanding
share, for a total purchase price of approximately $515 million.
This represents approximately a 21 percent premium over the closing
price of AnorMED's shares on September 25, 2006. (Logo:
http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO ) MOZOBIL,
currently in late-stage Phase III clinical development, is
anticipated to be launched in the U.S. in 2008 subject to
successful completion of clinical trials and regulatory approval.
MOZOBIL, a small molecule CXCR4 chemokine antagonist, works by
releasing stem cells from the bone marrow into circulation,
improving the ability to collect the stem cells for transplant.
Stem-cell transplants offer a potential cure for patients with
certain hematological malignancies. Currently, a majority of the
50,000 to 60,000 transplant-eligible patients worldwide are unable
to optimize the benefit of transplant due to sub-optimal stem-cell
collection. Assuming the acquisition is completed and MOZOBIL is
approved, the product would be sold by Millennium's oncology sales
force, which currently details VELCADE(R) (bortezomib) for
Injection, the market leader in relapsed multiple myeloma. "MOZOBIL
is an excellent strategic fit with Millennium's focus in
hematology-oncology, where our product VELCADE leads the market in
treating patients with relapsed multiple myeloma," said Deborah
Dunsire, M.D., President and Chief Executive Officer, Millennium.
"This proposed acquisition is aligned with our goal to bring in
products that accelerate revenue growth, leverage our oncology
sales infrastructure and benefit from our development, regulatory
and commercial expertise. We are extremely excited to carry forward
the innovative work of the AnorMED team and to improve outcomes for
transplant-eligible patients by bringing MOZOBIL to market." Strong
Clinical Progress for MOZOBIL In the September 2005 issue of Blood,
Neal Flomenberg, M.D., et al., reported that in a Phase II clinical
trial, 60 percent of patients who received MOZOBIL in combination
with the current standard of care for stem-cell mobilization,
granulocyte-colony stimulating factor (G-CSF), collected the
optimal target number of cells for transplant in two apheresis
days, compared to only 16 percent of patients who received G-CSF
alone. The cell yield in patients on MOZOBIL in combination with
G-CSF was on average 290 percent higher compared to the cell yield
in patients on G-CSF alone. The two ongoing randomized,
double-blinded Phase III trials, designed under the special
protocol assessment process with the Food and Drug Administration
(FDA), are exploring MOZOBIL with G-CSF compared to placebo with
G-CSF in multiple myeloma and non-Hodgkin's lymphoma (NHL)
patients. Patient enrollment was completed in the Phase III
multiple myeloma trial in July 2006 and, as of September 15, 2006,
92 percent of patients in the Phase III NHL trial had been enrolled
with total enrollment expected to be completed by the end of 2006.
Data from these registration-enabling trials are expected in 2007.
Based on preclinical data, MOZOBIL may also render patients with
certain hematological diseases more responsive to chemotherapy,
including patients with acute myelogenous leukemia (AML) and
chronic lymphocytic leukemia (CLL). Post-Acquisition Integration If
this transaction is completed, Millennium believes AnorMED would
strengthen Millennium's foundation in building a leading
biopharmaceutical company in oncology and inflammation. The assets
of the combined companies would consist of: * VELCADE - A
first-in-class, market-leading product which provides an unmatched
survival advantage to relapsed multiple myeloma patients.
Millennium was recently granted priority review with a PDUFA date
of December 9, 2006 by the FDA for its supplementary new drug
application covering VELCADE for relapsed mantle cell lymphoma.
Phase III trials are ongoing in newly diagnosed multiple myeloma
patients and relapsed follicular and marginal zone lymphoma
patients. Over 300 trials are ongoing or planned to explore the
potential of VELCADE in other cancers. * MOZOBIL - A
first-in-class, late-stage Phase III molecule for stem-cell
transplant in multiple myeloma and NHL with a planned U.S. launch
in 2008. MOZOBIL has additional potential in chemosensitization for
hematological diseases including AML and CLL. * Novel development
pipeline - A pipeline of nine oncology and inflammation molecules
in clinical development and late-stage preclinical development, in
addition to VELCADE and MOZOBIL. * Innovative discovery
organization - An oncology-focused discovery organization with
expertise in protein homeostasis, signal transduction and
cell-surface targets. In the past three years, six Millennium
discovered molecules have progressed to the development pipeline. *
Collaborations - Millennium is engaged in several strategic
alliances which provide significant revenues to Millennium through
royalties on product sales, milestone payments and reimbursements.
Alliances include an ex-U.S. commercialization and global
development agreement with Johnson & Johnson Pharmaceutical
Research & Development, L.L.C. (J&JPRD) for VELCADE, a
development and commercialization agreement with sanofi-aventis for
anti-inflammatory small molecules and a royalty-based agreement
with Schering-Plough Corporation for the marketed-product
INTEGRILIN(R) (eptifibatide) Injection. * Post-acquisition
integration plans are underway and will be announced at the closing
of the transaction. The focus of the integration is to accelerate
filing and launch of MOZOBIL. The transaction is expected to be
modestly accretive to Millennium in 2008 and significantly
accretive in 2009 and beyond assuming successful commercial launch
of MOZOBIL in 2008. Transaction Summary Millennium's acquisition of
AnorMED would take the form of an all cash tender offer to acquire
all of AnorMED's outstanding shares at the price of U.S. $12.00 per
share for a total amount of approximately U.S. $515 million.
Millennium's tender offer will commence within 10 days and is
expected to be open for at least 35 days. The boards of directors
of both companies have approved the transaction. Several investment
partnerships managed by Baker Brothers Advisors, L.L.C. and its
affiliates have also entered into an agreement to tender their
shares under the bid. Previously, AnorMED rejected an unsolicited
offer by Genzyme Corporation, announced September 1, 2006, at U.S.
$8.55 per share. In the event that the transaction between
Millennium and AnorMED does not close successfully, Millennium
would under certain circumstances be entitled to a termination fee
of $19.5 million. J.P. Morgan Securities Inc. acted as Millennium's
financial advisor and provided a fairness opinion to Millennium's
board of directors. Morgan Stanley also provided advisory services
to Millennium on this transaction. Conference Call Announcement In
conjunction with this news release, Millennium will host a live
webcast of a conference call today, September 26, 2006 at 11:30
A.M. ET. This webcast can be accessed by visiting the Investors
section of the Company's website, http://www.millennium.com/.
Following the webcast and following the posting of the transcript
from the conference call on the Millennium website, an archived
version of the call will be available at the same address for 30
days. Important Additional Information Will Be Filed with the
United States Securities and Exchange Commission This press release
is neither an offer to purchase nor a solicitation of an offer to
sell shares of AnorMED. At the time the tender offer is commenced,
Millennium will file with the United States Securities and Exchange
Commission (SEC) and the Canadian securities regulatory
authorities, and mail to AnorMED's shareholders a Take- Over Bid
Circular/Tender Offer Statement, and AnorMED will file with the SEC
and mail to its stockholders a Directors' Circular/Tender Offer
Solicitation/Recommendation Statement in connection with the
proposed transaction. These will contain important information
about Millennium, AnorMED, the transaction and other related
matters. Investors and security holders are urged to read each of
these documents carefully when they are available. Investors and
security holders will be able to obtain free copies of the
Take-Over Bid Circular/ Tender Offer Statement, the Directors'
Circular/Tender Offer Solicitation/Recommendation Statement and
other documents filed with the SEC by Millennium and AnorMED
through the website maintained by the SEC at http://www.sec.gov/
and by the Canadian securities regulatory authorities at
http://www.sedar.com/. In addition, investors and security holders
will be able to obtain free copies of these documents from
Millennium or AnorMED by contacting: Joel Goldberg, Corporate
Secretary at Millennium; William J. Adams, Corporate Secretary at
AnorMED; or the dealer manager named in such document. Cautionary
Note Regarding Forward-Looking Statements Statements in this press
release regarding the proposed transaction between Millennium and
AnorMED, the expected timetable for completing the transaction, the
anticipated launch of MOZOBIL, future financial and operating
results, benefits and synergies of the transaction, future
opportunities for the combined company, the development and
commercialization of VELCADE and MOZOBIL and any other statements
about Millennium or AnorMED managements' future expectations,
beliefs, goals, plans or prospects constitute forward- looking
statements. Any statements that are not statements of historical
fact (including statements containing the words "believes,"
"plans," "anticipates," "expects," estimates and similar
expressions) should also be considered to be forward-looking
statements. There are a number of important factors that could
cause actual results or events to differ materially from those
indicated by such forward-looking statements, including: the
ability to consummate the transaction; the ability of Millennium to
successfully integrate AnorMED's operations and employees; the
ability to realize anticipated synergies and cost savings; adverse
results in drug discovery and clinical development and regulatory
processes, particularly with respect to VELCADE and MOZOBIL; and
the other factors described in (1) Millennium's Quarterly Report on
Form 10-Q for the quarter ended June 30, 2006, which has been filed
with the SEC and (2) AnorMED's Annual Information Form filed June
29, 2006 on the System for Electronic Document Analysis and
Retrieval maintained by the Canadian Regulatory Authorities and
AnorMED's Form 40-F filed with the SEC on June 30, 2006. Millennium
disclaim any intention or obligation to update any forward- looking
statements as a result of developments occurring after the date of
this press release. About VELCADE 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).
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. VELCADE is approved in more than 75
countries worldwide. VELCADE also is approved in the European Union
as a treatment at first relapse. 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. 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/.
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) Lisa Adler (media) (617)
761-4734 (617) 444-3285
http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO
http://photoarchive.ap.org/ DATASOURCE: Millennium Pharmaceuticals,
Inc. CONTACT: Kyle Kuvalanka, +1-617-761-4734, or Lisa Adler,
+1-617-444-3285, both of Millennium Pharmaceuticals Web site:
http://www.millennium.com/ Company News On-Call:
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