Guilford Pharmaceuticals Withdraws European Regulatory Submission for Expanded Use of GLIADEL(R) Wafer
Tuesday November 19, 4:30 pm ET
BALTIMORE, Nov. 19 /PRNewswire-FirstCall/ -- Guilford Pharmaceuticals Inc. (Nasdaq: GLFD - News) announced today that it has elected to withdraw its regulatory application in Europe, filed in January 2002, seeking an expanded indication for its innovative cancer therapy, GLIADEL® Wafer, for use during initial surgery for malignant glioma. Currently, GLIADEL® Wafer is approved in 24 countries, including the United States, for use during recurrent surgery for glioblastoma multiforme (GBM), a rapidly fatal form of malignant brain cancer, and in Canada for use in both primary and recurrent surgery for GBM.
"The decision to withdraw is based on Guilford's preference to focus on obtaining an expanded label for GLIADEL® Wafer in the United States. Our current plan is to resubmit all data, including the long-term follow up data to the European regulatory authority at a later date," explained Craig R. Smith, M.D., Chairman and Chief Executive Officer of Guilford.
Earlier this year, Guilford announced results from a recently completed analysis of long-term survival when GLIADEL® Wafer is used during initial surgery for malignant glioma. The data demonstrate that GLIADEL® Wafer reduces the risk of dying over 3-4 years by 27% (p=0.017, unstratified log- rank test). In October 2002, Guilford provided these data to the Food and Drug Administration (FDA) as an amendment to its supplemental New Drug Application filed in April 2001.
About GLIADEL® Wafer
GLIADEL® Wafer is a small, white dime-sized wafer made of a biodegradable polymer that contains the cancer chemotherapeutic drug, carmustine or BCNU. Up to eight GLIADEL® Wafers can be implanted in the cavity created when a brain tumor is surgically removed. There, the wafers slowly dissolve over a period of 2 to 3 weeks, delivering chemotherapy directly to the tumor site in high concentrations, while minimizing drug exposure to other areas of the body.
Guilford Pharmaceuticals Inc. is a fully integrated pharmaceutical company that discovers, develops and markets novel pharmaceutical products targeting the hospital and neurological markets.
For more information about GLIADEL® Wafer, visit www.gliadel.com. For more information about Guilford Pharmaceuticals, visit www.guilfordpharm.com
Contact: Guilford Pharmaceuticals Inc.
Stacey Jurchison 410.631.5022
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