Genzyme Corporation to Acquire Bioenvision, Inc.
29 Mai 2007 - 4:09PM
PR Newswire (US)
To Gain Exclusive, Worldwide Rights to Clofarabine CAMBRIDGE, Mass.
and NEW YORK, May 29 /PRNewswire-FirstCall/ -- Genzyme Corporation
(NASDAQ:GENZ) and Bioenvision, Inc. (NASDAQ:BIVN) announced today
that they have reached an agreement under which Genzyme will
acquire Bioenvision in an all cash transaction valued at $5.60 per
outstanding common share, or approximately $345 million,
representing a premium of approximately 50 percent over the last
twenty trading day average. The transaction is expected to be
approximately six cents dilutive in 2007, slightly dilutive to
break-even in 2008, and accretive in 2009. With this transaction,
which has unanimous Bioenvision Board support, Genzyme takes
another significant step in enhancing its existing oncology
business by gaining the exclusive, worldwide rights to clofarabine.
Bioenvision and Genzyme co-developed clofarabine in Europe where
Bioenvision currently markets the product for the treatment of
acute lymphoblastic leukemia (ALL) in relapsed and refractory
pediatric patients. Clofarabine is also being developed by Genzyme
and Bioenvision for significantly larger indications, including use
as a first-line therapy for the treatment of adult acute myeloid
leukemia (AML). Clofarabine is branded as Clolar(R) in the U.S. and
Canada, where it is marketed by Genzyme for relapsed and refractory
pediatric ALL patients. Clofarabine has been granted orphan drug
status for ALL and AML in both the United States and European
Union. "Building an international commercial presence for our
oncology business has been a focus for the corporation and we are
very pleased to reach agreement with Bioenvision on this
transaction," stated Henri A. Termeer, chairman and chief executive
officer of Genzyme Corp. "We are deeply committed to furthering the
clinical development of clofarabine and making it available on a
global basis so that patients around the world with these very
difficult forms of cancer will have access to the therapy."
"Strategically, financially and operationally, this acquisition
makes great sense for our business," stated Mark J. Enyedy, senior
vice president and general manager of Genzyme Oncology, a business
unit of Genzyme Corporation. "We have developed a comprehensive
understanding of clofarabine and its clinical potential, and are
fully engaged in expanding its use into adult populations, most
notably and nearest-term in AML. Full ownership will accelerate the
development and commercialization of this important therapy."
Christopher B. Wood, M.D., chairman and chief executive officer of
Bioenvision, said, "We believe this transaction brings significant
value to Bioenvision shareholders. Genzyme has the global clinical,
regulatory and commercial infrastructure to advance clofarabine, as
well as very significant experience with the product from its U.S.
approval, launch, and continued development and commercialization.
We are confident that they will build upon the solid foundation our
organization has established in Europe to further expand access to
clofarabine for patients with serious unmet medical need." In
addition to clofarabine, Bioenvision also markets Modrenal(R)
(trilostane), approved in the United Kingdom for the treatment of
post- menopausal breast cancer following relapse from initial
hormone therapy, and has a pipeline in development to address unmet
needs in autoimmune disease and infectious disease. Clofarabine
Development Genzyme and Bioenvision each have robust clinical
development programs aimed at expanding clofarabine into adult
indications. The National Cancer Research Institute (NCRI), an
independent, UK-based cooperative group, is currently enrolling
patients in AML-16, a phase 2/3 study in older patients with AML or
high-risk myelodysplastic syndromes (MDS), in collaboration with
Bioenvision. The trial has two components: one focusing on patients
who are candidates for intensive chemotherapy, and another
non-intensive component focusing on patients who are not considered
fit for intensive chemotherapy. Each component will evaluate the
efficacy of clofarabine. Genzyme expects that the results from
AML-16 will enhance the data from its own pivotal trials of
clofarabine that are currently ongoing in adult AML populations.
Genzyme is advancing a phase 3 study (CLASSIC I) in adult AML
patients aged 55 and older and previously treated with at least
one, but not more than two, prior induction regimens. It is a
randomized, double-blind, controlled study that will compare the
combination of Clolar and cytarabine (Ara-C) to cytarabine alone. A
phase 2 pivotal clinical trial (CLASSIC II) evaluating the safety
and effectiveness of clofarabine in previously untreated, older
adult patients with AML who are unlikely to benefit from standard
induction therapy is expected to be fully enrolled later this year.
Each of these studies is expected to yield substantial evidence
supporting the expansion of the current clofarabine product label,
which is expected to occur in 2008. A separate phase 3 study of
clofarabine sponsored by the Eastern Cooperative Oncology Group is
expected to begin enrolling patients later this year. This study
will focus on previously untreated AML patients over the age of 60
who are considered suitable for standard induction chemotherapy.
Clolar is indicated in the U.S. for the treatment of pediatric
patients aged 1 to 21 years old with relapsed or refractory ALL
after at least two prior regimens. This use is based on the
induction of complete responses. Randomized trials demonstrating
increased survival or other clinical benefit have not been
conducted. Genzyme also is actively exploring additional
therapeutic indications for Clolar, including in MDS and bone
marrow transplant. Transaction Terms Genzyme's acquisition of
Bioenvision will take the form of an all cash tender offer, which
is expected to be completed in July. The transaction has been
approved by both boards of directors. Executive officers, directors
and shareholders of Bioenvision, representing approximately 20
percent of shares, have entered into agreements in support of the
transaction. The transaction is subject to customary closing
conditions. In association with the acquisition, Genzyme
anticipates that it will incur certain one time charges, which will
be detailed at the close of the transaction. About Genzyme One of
the world's leading biotechnology companies, Genzyme is dedicated
to making a major positive impact on the lives of people with
serious diseases. Since 1981, the company has grown from a small
start-up to a diversified enterprise with more than 9,000 employees
in locations spanning the globe and 2006 revenues of $3.2 billion.
Genzyme has been selected by FORTUNE as one of the "100 Best
Companies to Work for" in the United States. With many established
products and services helping patients in nearly 90 countries,
Genzyme is a leader in the effort to develop and apply the most
advanced technologies in the life sciences. The company's products
and services are focused on rare inherited disorders, kidney
disease, orthopaedics, cancer, transplant, and diagnostic testing.
Genzyme's commitment to innovation continues today with a
substantial development program focused on these fields, as well as
immune disease, infectious disease, and other areas of unmet
medical need. About Bioenvision, Inc. Bioenvision's primary focus
is the acquisition, development, and marketing of compounds and
technologies for the treatment of cancer. Bioenvision has a
pipeline of products for the treatment of cancer, including:
Evoltra(R) (clofarabine), Modrenal(R) (for which Bioenvision has
obtained regulatory approval for marketing in the United Kingdom
for the treatment of post- menopausal breast cancer following
relapse to initial hormone therapy), and other products.
Bioenvision is also developing anti-infective technologies,
including the OLIGON(R) technology; an advanced biomaterial that
has been incorporated into various FDA approved medical devices and
Suvus(R), an antimicrobial agent currently in clinical development
for refractory chronic hepatitis C infection. For more information
on Bioenvision please visit our Web site at
http://www.bioenvision.com/. Important Information About the Tender
Offer This announcement is not a recommendation, an offer to
purchase or a solicitation of an offer to sell shares of
Bioenvision stock. Genzyme has not commenced the tender offer for
shares of Bioenvision stock described in this announcement. Upon
commencement of the tender offer, Genzyme will file with the
Securities and Exchange Commission a tender offer statement on
Schedule TO and related exhibits, including the offer to purchase,
letter of transmittal, and other related documents. Following
commencement of the tender offer, Bioenvision will file with the
Securities and Exchange Commission a solicitation/recommendation
statement on Schedule 14D-9. Shareholders should read the offer to
purchase and solicitation/recommendation statement and the tender
offer statement on Schedule TO and related exhibits when such
documents are filed and become available, as they will contain
important information about the tender offer. Shareholders can
obtain these documents when they are filed and become available
free of charge from the Securities and Exchange Commission's
website at http://www.sec.gov/, or from Genzyme by directing a
request to Genzyme, 500 Kendall Street, Cambridge, MA 02142,
Attention: Sally Curley, Investor Relations, (617) 768-6140, or
from Bioenvision, Inc., 345 Park Avenue, 41st Floor, New York, New
York 10154, Attention: James Scibetta, Chief Financial Officer,
(212) 750-6700. In connection with the proposed transactions
contemplated by the definitive agreement between Genzyme and
Bioenvision, Bioenvision and its directors, executive officers and
other employees may be deemed to be participants in any
solicitation of Bioenvision stockholders in connection with such
proposed transactions. Information about Bioenvisions's directors
and executive officers is available in Bioenvision's proxy
statement for its 2006 annual meeting of stockholders, as filed
with the SEC on October 20, 2006. Conference Call Information There
will be a joint conference call today at 10:00 a.m. ET to discuss
the proposed tender offer. If you would like to participate, please
call (773) 799-3828 and use the passcode "Genzyme." A replay of
this call will be available from 9 a.m. ET on May 30, 2007, until
midnight ET on June 5, 2007, by calling (402) 220-3138. This call
will also be webcast live at the investor section of
http://www.genzyme.com/. Safe Harbor Statement This press release
contains forward-looking statements, including the statements
regarding: structure and timing of the tender offer; the potential
benefits of the anticipated transaction; the extent to which the
acquisition ultimately advances Genzyme's oncology businesses;
expectations regarding the timing of, and announcement of data
from, clinical trials for clofarabine; estimates of the potential
markets and indications for clofarabine; and the expected impact of
the anticipated transaction on Genzyme's earnings and expected
dilutive/accretive effect. 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 possibility that certain closing conditions will not be met;
the ability to successfully integrate Bioenvision's operations and
programs with Genzyme's and the time and resources required to do
so; the ability to attract and retain qualified employees; the
actual design, results and timing of clinical studies for
clofarabine; enrollment rates for clinical trials; the extent to
which the safety and efficacy of clofarabine is demonstrated; the
actual timing and content of submissions to and decisions made by
regulatory authorities concerning the approval of clofarabine; the
ability to manufacture sufficient quantities of clofarabine for
development and commercialization activities and to do so in a
timely and cost-efficient manner; the availability and extent of
reimbursement from third party payers for clofarabine in
territories outside of the United States; the scope, validity and
enforceability of patents directed to, and the effect of any third
party proprietary rights on, clofarabine; the accuracy of Genzyme's
information concerning the markets for clofarabine, including
growth projections; and the risks and uncertainties described in
Genzyme's SEC reports filed under the Securities Exchange Act of
1934, including the factors discussed under the caption "Risk
Factors" in Genzyme's Quarterly Report on Form 10-Q for the period
ended March 31, 2007. We caution investors not to place undue
reliance on the forward-looking statements contained in this
document. These statements speak only as of the date of this
document and we undertake no obligation to update or revise the
statements. Genzyme(R) and Clolar(R) are registered trademarks of
Genzyme Corporation. Evoltra(R), Modrenal(R), OLIGON(R) and
Suvus(R) are registered trademarks of Bioenvision, Inc. All rights
reserved. 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 1-678-999-4572 outside the United States. CONTACTS: For
Genzyme For Bioenvision Sally J. Curley (investors) James S.
Scibetta (investors) (617) 768-6140 (212) 750-6700 Maria E. Cantor
(media) Andrea L. Johnston (media) (617) 768-6690 (910) 616-5858
DATASOURCE: Genzyme Corporation CONTACT: For Genzyme - Sally J.
Curley (investors), +1-617-768-6140; or Maria E. Cantor (media),
+1-617-768-6690; For Bioenvision - James S. Scibetta (investors),
+1-212-750-6700; or Andrea L. Johnston (media), +1-910-616-5858 Web
site: http://www.genzyme.com/ Company News On-Call:
http://www.prnewswire.com/comp/113803.html
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