Pending Anormed purchase:
Millennium Agrees to Acquire AnorMED, Adding Phase III Oncology Product with Planned Near Term Launch Date
Tuesday September 26, 9:46 am ET
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 - News) today announced it has entered into an agreement to acquire AnorMED, Inc. (Nasdaq: ANOR - News; TSX: AOM - News), 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.
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® (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® (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, 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.
