Gliadel Wafer

Guilford Pharmaceuticals Inc., (NASDAQ: GLFD) announced today that it has filed a submission in Europe seeking an expanded indication for its innovative cancer therapy, GLIADEL(R) Wafer, for use during initial surgery for malignant glioma. Currently, GLIADEL(R) 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.

GLIADEL(R) Wafer is a biodegradable wafer, implanted at the time of surgery, that delivers chemotherapy directly to the tumor site, minimizing drug exposure to other areas of the body. GLIADEL(R) Wafer complements other standard therapies for brain cancer, such as surgery, radiation and traditional intravenous chemotherapy.

"Our European submission is an important commercial milestone for the Company," commented Craig R. Smith, M.D., President and Chief Executive Officer of Guilford. "In Europe, the surgical treatment of malignant glioma is often restricted to initial surgery; with recurrent surgeries occurring much less frequently than in the United States. Obtaining marketing authorization for GLIADEL(R) Wafer for use during initial surgery in Europe creates a much broader market opportunity for the product than presently exists, and second, provides improved treatment options for patients with this devastating disease."

The European regulatory submission is based on favorable results from a randomized, double-blind, placebo-controlled Phase III clinical trial, which demonstrated a 30 percent improvement in survival rates in patients who received GLIADEL(R) Wafer therapy at the time of their initial diagnosis and surgery for malignant glioma.

In the study, at one year, 59 percent of patients given GLIADEL(R) Wafer were still alive compared to 48 percent of those given placebo. A secondary endpoint in the study - improvement in neurological symptoms - also demonstrated a statistically significant benefit in the GLIADEL(R) Wafer treatment group.

GLIADEL(R) Wafers have generally been well tolerated. However, GLIADEL(R) Wafer contains carmustine and should not be given to patients who are allergic to carmustine. Carmustine can also cause fetal harm when administered to a pregnant woman. Patients undergoing surgery for malignant brain cancer and implantation of GLIADEL(R) Wafer should be monitored closely for the following known complications of surgery including: seizures, intracranial infections, abnormal wound healing, and brain edema. Each of these complications has been associated with GLIADEL(R) Wafer treatment.

About GLIADEL(R) Wafer

GLIADEL(R) 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(R) 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 global, fully-integrated pharmaceutical company targeting the neurological, surgical and critical care markets. The Company's mission is to develop proprietary biopolymer-based therapeutics for surgeons and novel pharmaceutical products for the diagnosis and treatment of neurological disorders.

For more information about GLIADEL(R) Wafer, visit www.gliadel.com.

For more information about Guilford Pharmaceuticals, visit 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 Registration Statement on Form S-3 filed with the SEC on June 21, 2001 (File No. 333-63576). Among other things, there can be no assurance that the European regulatory agencies will approve GLIADEL(R) Wafer for initial therapy in patients newly diagnosed with malignant glioma, or that if approved GLIADEL(R) Wafer will achieve market acceptance for the expanded indication.