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GUILFORD SUBMITS TO FDA AN AMENDMENT TO GLIADEL® WAFER SUPPLEMENTAL NEW DRUG APPLICATION


Posted on: 11/01/2002

FOR IMMEDIATE RELEASE

GUILFORD SUBMITS TO FDA AN AMENDMENT TO GLIADEL® WAFER SUPPLEMENTAL NEW DRUG APPLICATION

New Long-Term Data Demonstrate GLIADEL® Wafer Reduces the Risk of Dying Over 3-4 Years By 27% in Patients with High-Grade Malignant Glioma

BALTIMORE, MD, November 1, 2002 - Guilford Pharmaceuticals Inc. (NASDAQ: GLFD) announced today that it has submitted to the Food and Drug Administration (FDA) an amendment to its supplemental New Drug Application (sNDA) for GLIADEL® Wafer seeking approval for use during initial surgery for high-grade malignant glioma. GLIADEL® Wafer is currently approved for the treatment of recurrent glioblastoma multiforme (GBM), a common form of malignant brain cancer. The amendment contains new data from a recently completed analysis of long-term survival, which demonstrate that GLIADEL® Wafer reduces the risk of dying over 3-4 years by 27% (p=0.017, unstratified log-rank test).

In April 2001, Guilford submitted an sNDA for GLIADEL® Wafer seeking an expanded indication for use in initial surgery for malignant glioma. In March 2002, the FDA issued a not approvable letter to Guilford indicating concerns regarding the survival benefit associated with GLIADEL® Wafer treatment during initial surgery. In response, Guilford proposed to the FDA that the Company obtain an additional two years of follow up data on patients enrolled in the GLIADEL® Wafer Phase III clinical trial, under the assumption that the additional data might address FDA's concerns. The FDA and Guilford mutually agreed on the protocol and methods for collecting and analyzing the long-term follow up data. Guilford presented the results of the analysis to FDA on September 19, 2002. After completing an informal review of these data, the FDA advised Guilford that the submission of an amendment to the Company's sNDA containing the long-term follow up data would receive a formal FDA review and reconsideration of the requested new labeling for the product.

"We believe these new data provide evidence of a long-term survival benefit when GLIADEL® Wafer is used during the initial surgical treatment of patients with a high-grade malignant glioma. The reduction in the risk of dying when GLIADEL® Wafer is used is consistent across all trials and is generally observed to be between 25 to 30 percent, further strengthening our conclusions, " said Craig R. Smith, M.D., Chairman and Chief Executive Officer. "We're very encouraged by these new data, and look forward to continuing to work with FDA to facilitate their review."

The Phase III clinical trial was a randomized, double-blind, placebo-controlled study conducted at 38 centers in 14 countries. A total of 240 adult men and women undergoing initial surgical resection of a high-grade malignant glioma were enrolled and randomly assigned to receive implantation of either GLIADEL® Wafers or placebo wafers into the resection cavity followed by radiation therapy. Patients were enrolled in the trial from December 1997 to June 1999. The primary end-point for the trial was survival estimated by the Kaplan-Meier method and compared using the log-rank test. Follow-up for the Phase III clinical trial was completed in June of 2000, one year after enrollment of the last patient in the trial, and the results were presented at the Society for Neuro-Oncology meeting in November 2000.

Long-Term Survival Results

Complete follow-up for the long-term survival analysis was obtained on 239 patients (99.6%) out of a total of 240 patients enrolled in the Phase III clinical trial. One patient was lost to follow-up. By the end of two additional years of follow-up in August 2002, 228 patients were known to have died. Of the 11 patients known to be alive on the date of last follow up, 9 received GLIADEL® Wafer and 2 received placebo.

Overall, during the 3-4 years of follow-up, the hazard ratio for GLIADEL® Wafer treated patients relative to placebo treated patients was 0.73 (95% CI: 0.56 to 0.95), indicating a reduction in the risk of dying of 27% (p=0.017, unstratified log-rank test).

Pre-specified Cox proportional hazards models were used to estimate the treatment effect of GLIADEL® Wafer after accounting for the effects on survival of known prognostic factors (age, Karnofsky Performance Scores, and tumor type) or known sources of survival variability (country of treatment) and the results of the Cox models supported the results obtained from the log-rank test.

About GLIADEL® Wafer

GLIADEL® Wafer is the only marketed cancer treatment capable of delivering chemotherapy directly to the site of a brain cancer, minimizing drug exposure to other areas of the body. GLIADEL® Wafer is a small, white to off-white dime-sized wafer comprised of a biodegradable polymer (polifeprosan 20) incorporating 7.7 mg. of carmustine (BCNU), a chemotherapeutic agent usually administered intravenously to treat a malignant glioma. Up to eight GLIADEL® Wafers can be implanted in the cavity created when a surgeon removes a brain tumor. There, they slowly dissolve, releasing BCNU directly to the tumor site in high concentrations, while minimizing drug exposure to other areas of the body. GLIADEL® Wafer is currently indicated for use as an adjunct to surgery to prolong survival in patients with recurrent glioblastoma multiforme (GBM) for whom surgical resection is indicated.

About Primary Brain Cancer

Primary brain cancers are tumors that originate from cells normally found in the brain. The most common type of malignant primary brain cancer is a malignant glioma which is derived from the supporting cells in the brain called glial cells. The most common types of malignant glioma are glioblastoma multiforme (GBM), anaplastic astrocytoma, and oligodendroglioma. Glioblastoma multiforme is one of the most rapidly progressive and fatal forms of cancer. According to the American Brain Tumor Association, there are approximately 36,000 primary brain cancers diagnosed in the United States each year. Approximately 18,000 of these are malignant gliomas of which 8,000 are GBMs. Even with aggressive conventional treatment the typical patient with a high-grade malignant glioma lives less than one year after diagnosis. Guilford estimates that about 3,000 - 4,000 patients undergo re-operation for recurrent malignant glioma each year in the United States and approximately 8,000 -12,000 patients undergo an initial resection of a high-grade malignant glioma.

Guilford Pharmaceuticals Inc. is a fully integrated pharmaceutical company that discovers, develops and markets novel pharmaceutical products targeting the hospital and neurological markets.

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Contact: Guilford Pharmaceuticals Inc.

Stacey Jurchison 410.631.5022

Internet addresses: www.guilfordpharm.com

This press release contains forward-looking statements that involve risks and uncertainties, including those described in the section entitled "Risk Factors" contained in the Company's Annual Report on Form 10-K filed with the SEC on March 26, 2002, that could cause the Company's actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. Among other things, there can be no assurance that the FDA will concur with the Company's interpretation of the results of the GLIADEL® Wafer Phase III Clinical Trial, or that the FDA will approve a label expansion for GLIADEL® Wafer beyond its current indication.


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