Genzyme Corp.
(Nasdaq: GENZ) announced the withdrawal of the European application
to extend the Evoltra(R) (clofarabine) product label to include the
treatment of elderly patients with acute myeloid leukemia (AML). This
application and the data on which it was based were filed by Bioenvision,
Ltd. before the company was acquired by Genzyme last year.
In a letter to the European Medicines Agency (EMEA) on behalf of
Bioenvision, Genzyme states that the withdrawal is based on the EMEA's
Committee for Medicinal Products for Human Use (CHMP) assessment that the
data from the BIOV121 study are not sufficient to support a recommendation
for market approval at this time. Bioenvision is now a wholly-owned
subsidiary of Genzyme.
"As we expected, the filing that Bioenvision submitted to the EMEA was
not sufficient to support approval in adult AML and our subsequent
conversations with the CHMP have confirmed this assessment," stated Mark J.
Enyedy, president of Genzyme Oncology, a business unit of Genzyme Corp. "We
have engaged in a positive dialogue with the Rapporteurs regarding the
requirements for approval and will develop a new submission to include data
from one or more ongoing clinical studies of clofarabine in this patient
population for submission possibly as early as the fourth quarter of this
year."
In the United States, Genzyme has completed enrollment for a pivotal
study in previously untreated, older adult patients with AML who are
unlikely to benefit from standard intensive induction chemotherapy. Data
from this study, known as CLASSIC II, are expected to provide substantial
evidence for expanding the current product label into adult AML.
Preliminary data has been accepted for presentation at ASCO this spring and
a supplemental new drug application (sNDA) for clofarabine is expected to
be filed in the second half of this year. It is possible that data from
this study also could be considered for part of a new filing with EMEA.
Evoltra is currently indicated for the treatment of acute lymphoblastic
leukemia (ALL) in pediatric patients who have relapsed or are refractory to
at least two prior regimens. The withdrawal of the European application of
Evoltra in adult AML has no consequences for patients enrolled in current
clinical trials or compassionate use programs.
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 10,000 employees in locations
spanning the globe and 2007 revenues of $3.8 billion. In 2007, Genzyme was
chosen to receive the National Medal of Technology, the highest honor
awarded by the President of the United States for technological innovation.
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.
This press release contains forward-looking statements, including the
expected results of the data generated from clofarabine clinical trials,
the presentation and use of this data to support regulatory filings, and
the requirements and plans for regulatory filings and approvals for
clofarabine in additional indications. These risks and uncertainties
include, among others, the timing and results of clinical studies for
clofarabine; the timing of discussions with the EMEA and FDA regarding
clinical study results and approval of clofarabine in additional
indications; the timing and content of decisions by the EMEA and FDA
related to clinical trials and approval of clofarabine in additional
indications; the actual efficacy and safety of clofarabine for the
indications in which it is being tested; and the risks and uncertainties
described in reports filed by Genzyme with the U.S. Securities and Exchange
Commission, including without limitation the factors discussed under the
caption "Risk Factors" in Genzyme's Annual Report on Form 10-K for the year
ended December 31, 2007. 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 or revise the statements.
Genzyme(R) and Evoltra(R) are registered trademarks of Genzyme
Corporation or its subsidiaries. All rights reserved.
Genzyme Corp.
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