Gliadel®: Press Release

FDA Approves New Indication for GLIADEL® Wafer

BALTIMORE, MD, Feb. 26, 2003 -
Guilford Pharmaceuticals, Inc. (Nasdaq: GLFD) announced today that the company's marketed product, GLIADEL Wafer (polife- prosan 20 with carmustine implant), has received approval from the United States Food and Drug Administration (FDA) for use in newly diagnosed patients with high-grade, malignant glioma as an adjunct to surgery and radiation.

"I believe these findings will prompt many physicians to incorporate this therapy at the time of initial surgery"

"This action by FDA brings new hope to seriously ill patients with brain cancer," commented Henry Friedman, M.D., the James B. Powell, Jr. Professor of Neuro-

Oncology, and Co-Director of The Brain Tumor Center at Duke University. “ The clinical results with GLIADEL Wafer at the

“The benefits of GLIADEL® Wafer will now be available to a broader number of patients.”

time of initial surgery are clinically meaningful and statistically significant. I believe these findings will prompt many physicians to incorporate this therapy at the time of initial surgery. Along with radiotherapy and systemic chemotherapy, GLIADEL Wafer's use at the time of initial surgery forms the basis of a four pronged attack on malignant brain cancer."

"Guilford is proud of its commitment to develop new, innovative therapies, such as GLIADEL Wafer, that have a significant impact on the lives of patients," commented Craig R. Smith, M.D., Chairman and Chief Executive Officer. With an expanded label indication that provides for administration of GLIADEL Wafer at the time of initial surgery, followed by radiation, the benefits of GLIADEL Wafer will now be available to a broader number of patients."

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