CAMBRIDGE, Mass.,
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
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.
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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
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SOURCE Genzyme Corp.