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
SOURCE Genzyme Corporation
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Related links:
http://www.genzyme.com
http://www.prnewswire.com/comp/113803.html /
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
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