Will Resubmit With New Data from Ongoing Studies
CAMBRIDGE, Mass., March 19 /PRNewswire-FirstCall/ -- Genzyme Corp. (Nasdaq: GENZ) today 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.
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.
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