Genzyme Corporation to Acquire ILEX Oncology, Inc.
26 Fevereiro 2004 - 6:10PM
PR Newswire (US)
Genzyme Corporation to Acquire ILEX Oncology, Inc. Takes Important
Step to Establish Oncology Franchise CAMBRIDGE, Mass. and SAN
ANTONIO, Texas, Feb. 26 /PRNewswire-FirstCall/ -- Genzyme
Corporation and ILEX Oncology, Inc. announced today a
mergeragreement under which ILEX shareholders will receive shares
of Genzyme common stock valued at $26.00 per share, or
approximately $1 billion in equity value. Excluding amortization,
the transaction is expected to be dilutive to Genzyme's near-term
earnings and accretive in 2006. With this transaction, Genzyme
takes a significant step toward fulfilling its goal of building an
oncology business. ILEX offers a strong franchise with a growing
marketed product, a promising pipeline with two late-stage products
and a first-class clinical development organization. The pipeline
significantly augments Genzyme's long-standing program in oncology,
which includes a research and early development portfolio with
particular strengths in antibodies, small molecules and cell-based
therapeutics. The merger also capitalizes on Genzyme's substantial
expertise in biologics and targeted therapeutics, and its expanding
oncology testing business. Genzyme is one of the world's top five
biotechnology companies, with ten major marketed products and a
global regulatory, manufacturing and commercial infrastructure.
Cancer, unquestionably, represents a significant unmet medical need
that includes well-defined groups of addressable patient
populations. This market is one of great opportunity for Genzyme,
which is dedicated to making a major positive impact on the lives
of patients with serious diseases. "This transaction is a very good
strategic fit for Genzyme that provides us with a solid franchise
in the important field of oncology," stated Henri A. Termeer,
chairman and chief executive officer, Genzyme Corporation. "Through
this merger, we gain an experienced team that has brought a cancer
therapy from development to market. The combined strength of the
ILEX program and Genzyme's oncology pipeline expertise and
infrastructure will provide the foundation for a sustainable and
competitive commercial oncology business." "We believe this
transaction brings significant value to ILEX shareholders and
recognizes the high quality oncology franchise that we at ILEX have
built," said Jeffrey Buchalter, president and chief executive
officer, ILEX Oncology, Inc. "Genzyme is a top-tier biotech company
with the resources and commitment to take us to the next level as
we continue to expand our markets and, ultimately, commercialize
our own products." Genzyme plans to maintain ILEX operations in San
Antonio, acknowledging the impressive work currently underway by
the ILEX team. A Growing Marketed Product ILEX's lead product,
CAMPATH(R) (alemtuzumab for injection), is indicated in the United
States for the treatment of B-cell chronic lymphocytic leukemia
(B-CLL). CAMPATH is already having a significant impact in
oncology, less than three years after earning U.S. marketing
approval. CAMPATH is a humanized monoclonal antibody that binds to
a specific target, CD52, on cell surfaces directing the body's
immune system to destroy malignant cells. The U.S. Food and Drug
Administration approved CAMPATH for the treatment of B-CLL in
patients who have been treated with alkylating agents and who have
failed fludarabine therapy. It is the first and only monoclonal
antibody approved by the FDA for the treatment of patients with B-
CLL. ILEX and its marketing partner, Schering AG (NYSE:SHR), are
currently conducting a number of additional trials with CAMPATH to
expand its use. A Phase III comparison trial with chlorambucil, if
successful, will help establish CAMPATH as a useful therapy for
earlier-line B-CLL treatment. ILEX expects to fully enroll this
trial with nearly 300 patients this year. Similarly, ILEX has
initiated a fludarabine combination Phase III trial that will
examine the efficacy of combining CAMPATH with one of the most
commonly used agents for CLL. Two Phase I/II trials of CAMPATH have
been initiated in non-Hodgkin's lymphoma (NHL), one in combination
with Rituxan(R) and another as a single agent in relapsed or
refractory low-grade NHL. Additionally, CAMPATH is demonstrating
its potentialto treat other diseases beyond cancer. A randomized
Phase II trial against Rebif(R) in treating multiple sclerosis
should be fully enrolled in 2004 and abstracts from
investigator-sponsored studies of CAMPATH in solid organ transplant
surgery are expected to be presented at the American Transplant
Congress in May. Schering AG holds exclusive worldwide marketing
and distribution rights plus additional exclusive rights in Japan
and the Asian Pacific region to CAMPATH (MABCAMPATH(R) in Europe).
In the United States, the product is marketed by approximately 100
oncology sales representatives of Berlex Laboratories, a U.S.
affiliate of the Schering AG Group. ILEX currently fields a
12-member force of medical scientific liaisons to support the
investigational research being done with CAMPATH and other ILEX
pipeline products. In 2003, global net sales of CAMPATH reported by
Schering AG were $71.7 million, compared to $44.1 million in 2002,
a growth rate of 63%. ILEX reported revenues in 2003 of $34.8
million, primarily driven by the contribution of CAMPATH. At the
end of 2003, ILEX had $198 million in cash and marketable
securities. Strategic Pipeline ILEX's lead pipeline candidate is
clofarabine, a next-generation purine nucleoside analogue that
inhibits both DNA and RNA synthesis. ILEX is currently
investigating clofarabine for use in pediatric and adult acute
leukemias, as well as advanced solid tumors. ILEX has initiated a
rolling New Drug Application (NDA) with the FDA for treatment of
relapsed or refractory acute leukemias in children following
receipt of a fast track designation, and Genzyme expects approval
of clofarabine in 2005. ILEX recently reported positive interim
results from Phase II studies for clofarabine in pediatricand adult
acute leukemia. Phase I studies evaluating clofarabine in advanced
solid tumors are currently underway in both intravenous and oral
formulations. ILEX holds the rights from Bioenvision, Inc.
(AMEX:BIV) to develop and market clofarabine for cancer
applications in the United States and Canada. Bioenvision is
responsible for developing clofarabine in the rest of the world.
ILEX's Phase II pipeline candidate is ILX-651, a synthetic analog
of the natural substance dolastatin that has a uniquemechanism of
action targeting tubulin. ILEX is currently enrolling Phase II
trials in melanoma and non- small cell lung cancer after seeing
promising activity in Phase I solid tumor trials. ILEX has
exclusive worldwide rights to ILX-651 in cancer. ILEX's product
portfolio will serve as a solid complement to Genzyme Oncology's
research and development pipeline that is pursuing direct anti-
tumor approaches, anti-angiogenesis and immunotherapy. Genzyme
Oncology expects to report data from its PhaseI/II trial of a
patient-specific vaccine for kidney cancer at the June meeting of
the American Society of Clinical Oncology. It is also making
substantial progress in its collaboration with the pharmaceutical
division of Kirin Brewery of Japan around its proprietary portfolio
of tumor endothelial markers (TEMs). Genzyme Oncology has generated
fully human antibodies to a number of the TEMs that demonstrate
significant activity in in vitro models of angiogenesis and in in
vivo models with tumor- bearing mice. Kirin has agreed to fund
additional research and the collaboration expects to identify a
development candidate this year. Genzyme Oncology has also
accelerated its activity in approaches to cancer with a Phase I-II
trial of a small moleculethat offers promise in liver cancer. A
preclinical program with tumor-targeted compounds is underway and
preclinical work with inhibitors of PRL-3, a gene believed to be
implicated in metastatic colon cancer, is also expected to begin in
2004. Transaction Terms Genzyme's business combination with ILEX
will take the form of a stock- for-stock merger and is expected to
be completed by the middle of the year. Under the terms of the
agreement, ILEX shareholders will receive shares of Genzyme General
common stock for each ILEX share owned based on an exchange ratio.
This exchange ratio will equal $26.00 divided by the average
(rounded to the nearest cent) of the per share closing prices of
Genzyme common stock as reported by Nasdaq during the 20 trading
days ending on the fifth trading day prior to the closing of the
transaction, provided that if this average is greater than $59.88,
then the exchange ratio will be 0.4342, and if this average is less
than $46.58, then the exchange ratio will be 0.5582. Cash will be
paid for fractional shares. The tax-free transaction has a total
value of approximately $1 billion, based on ILEX's 39.0 million
shares outstanding today and Genzyme's offer price of $26 per
share. The transaction has been approved by the boards of directors
of both companies, and is subject to clearance under the
Hart-Scott-Rodino Antitrust Improvements Act and approval of ILEX's
stockholders. In association with the transaction, Genzyme
anticipates it may incur charges associated with purchase
accounting which will be detailed following its closing. About
Genzyme Genzyme Corporation is a global biotechnology company
dedicated to making a major positive impact on the lives of people
with serious diseases. The company's broad product portfolio is
focused on rare genetic disorders, renal disease, osteoarthritis
and immune-mediated diseases, and includes an industry-leading
array of diagnostic products and services. Genzyme's commitment to
innovation continues today with research into novel approaches to
cancer, heart disease, and other areas of unmet medical need. More
than 5,300 Genzyme employees in offices around the globe serve
patients in over 80 countries. About ILEX ILEX Oncology, Inc. is an
oncology drug development company. ILEX maintains a core competency
in oncology drug development, with locations in San Antonio, Texas
and Guildford, England. ILEX also conducts research in angiogenesis
inhibition, cell signaling, medical chemistry and nuclear receptor
biology at its laboratories in Boston, Massachusetts and Geneva,
Switzerland. This press release is not a substitute for the
prospectus/proxy statement Genzyme and ILEX intend to file with the
U.S. Securities and Exchange Commission. Investors are urged to
read that document when it becomes available, because it will
contain important information about Genzyme, ILEX, the proposed
business combination and related matters, including detailed risk
factors. The prospectus/proxy statement and other documents filed
by Genzyme and ILEX with the SEC will be available free of charge
at the SEC's website (http://www.sec.gov/) and from Genzyme or
ILEX. Requests for copies of Genzyme's SEC filings can be directed
to Genzyme Corporation, 500 Kendall Street, Cambridge,
Massachusetts 02142, Attention: Investor Relations. Requests for
copies of ILEX's SEC filings can be directed to Ilex Oncology,
Inc., 4545 Horizon Hill Blvd., San Antonio, Texas 78229, Attention:
Investor Relations. ILEX, its directors, andcertain of its
executive officers and employees may be deemed to be participants
in the solicitation of proxies from ILEX's stockholders in favor of
the transaction. Information about the directors and executive
officers of ILEX and their ownership ofILEX stock is set forth in
the proxy statement for ILEX's 2003 annual meeting of stockholders
and other filings with the SEC. Certain directors, executive
officers and employees of ILEX may have direct or indirect interest
in the transaction due to securities holdings, vesting of options
and rights to severance payments. In addition, ILEX's current
directors and officers, after the merger, will be entitled to
indemnification by Genzyme and benefit from insurance coverage for
certain liabilities that may arise from their service as directors
and officers of ILEX prior to the merger. Additional information
regarding the participants in the solicitation of ILEX's
stockholders will be included in the prospectus/proxy statement.
This press release contains forward-looking statements, including
statements about: the potential business combination between
Genzyme and ILEX; the impact of the anticipated transaction on
Genzyme's operations and the potential benefits of the anticipated
transaction; plans for expanding the indications of, and uses for,
ILEX's products and product candidates; and expectations regarding
the commencement and completion of, and announcement of data from,
clinical trials conducted by or on behalf of both companies. These
statements are subject to risks and uncertainties that could cause
actual results to differ materially from those projected in these
forward-looking statements. These risks and uncertainties include,
among others: the willingness of ILEX shareholders to vote their
shares in favor of the potential business combination; the receipt
of regulatory and third party consents to the extent required for
the transaction; the ability to successfully integrate ILEX's
operations and programs with Genzyme's and the time and resources
required to do so; the actual design, results and timing of
preclinical and clinical studies for both companies' products and
product candidates; enrollment rates for both companies' clinical
trials; the actual timing and content ofsubmissions to and
decisions made by regulatory authorities regarding each company's
products and product candidates, including the receipt of marketing
approval in the United States for Clofarabine; the ability to
manufacture sufficient quantities of products for development and
commercialization activities and to do so in a timely and
cost-efficient manner; the ability to attract and retain qualified
sales forces; the availability and extent of reimbursement from
third party payers for ILEX's products and product candidates; the
scope, validity and enforceability of patents directed to, and the
effect of any third party proprietary rights on, ILEX's products
and product candidates; the accuracy of Genzyme's and ILEX's
information concerning the markets for their respective products
and product candidates, including growth projections; and the risks
and uncertainties described in reports filed by Genzyme and ILEX
with the Securities and Exchange Commission under the Securities
Exchange Act of 1934, as amended, including without limitation the
information contained under the heading "Factors Affecting Future
Operating Results" in Genzyme's Quarterly Report on Form 10Q for
the quarter ended September 30, 2003 and in ILEX's Form 10-K for
the yearended December 31, 2002. We caution investors not to place
undue reliance on the forward-looking statements contained in this
press release. These statements speak only as of the date of this
press release, and we undertake no obligation to update orrevise
the statements, risks or reasons. All forward looking statements
are expressly qualified in their entirety by this cautionary
statement. Genzyme(R) is a registered trademark of Genzyme
Corporation. CAMPATH(R) and MABCAMPATH(R) are registered trademarks
of ILEX Oncology, Inc. or its subsidiaries. Rituxan(R) is a
registered trademark of Biogen Idec, Inc. Rebif(R) is a registered
trademark of Ares Trading S.A. Conference Call Information There
will be a joint conference call today at 5:30 p.m. ET to discuss
the proposed merger between Genzyme Corporation and ILEX Oncology,
Inc. If you would like to participate, please call 719-457-2658. A
replay of this call will be available from 8:30 p.m. ET on
Thursday, February 26 to midnight ET on March 4 by calling
719-457-0820. Please refer to reservation number 740574. This call
will also be webcast live at the investor section of
http://www.genzyme.com/. Morgan Stanley acted as financial advisor
and Ropes & Gray LLP acted as legal counsel to Genzyme. UBS
Securities LLC and Fulbright & Jaworski, L.L.P. acted as
financial and legal advisors, respectively, for ILEX. Genzyme's
press releases and other company information are available at
http://www.genzyme.com/ and by calling Genzyme's investor
information line at 1-800- 905-4369 within the United States or
1-703-797-1866 outside the United States. CONTACTS: For ILEX For
Genzyme Craig Tooman (all inquiries) Sally Curley (investors) (210)
949-8209 (617) 768-6140 Maria Foley (media) (617) 768-6690
DATASOURCE: Genzyme Corporation CONTACT: Craig Tooman (all
inquiries) for ILEX, +1-210-949-8209; or Sally Curley (investors),
+1-617-768-6140, or Maria Foley (media), +1-617-768-6690, both of
Genzyme Web site: http://www.genzyme.com/ Company News On-Call:
http://www.prnewswire.com/comp/104284.html
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