Gliadel Wafer

Guilford Pharmaceuticals Inc., (NASDAQ: GLFD) announced today that the Oncologic Drugs Advisory Committee (ODAC) voted 8 to 5 that GLIADEL(R) Wafer (polifeprosan 20 with carmustine implant) provides clinical benefit with an acceptable safety profile for the treatment of patients with newly diagnosed malignant glioma. Some committee members, however, expressed concerns about the size of the study, the analytical methods and the pathological diagnosis. While the FDA is not bound by the recommendation, it traditionally follows the Committee's advice.

"The positive outcome of the FDA Advisory Committee meeting is an important step forward in our efforts to bring the benefits of GLIADEL(R) Wafer to more patients," said Craig R. Smith, M.D., President and Chief Executive Officer of Guilford. "We will continue to work closely with the FDA to help them expeditiously complete their action on our sNDA." Clinical Trial Design

The Committee based their recommendation to approve an expanded label for GLIADEL(R) Wafer on a randomized, double-blind, placebo-controlled Phase III clinical trial, which was conducted in 240 eligible men and women at 38 study centers in 14 countries. Beginning in December 1997, patients were enrolled and randomly assigned to receive either GLIADEL(R) Wafer or placebo wafers, in addition to receiving standard therapy for malignant glioma, which included surgery and radiation.

The primary endpoint in the study was overall survival at 12 months. Depending on the date of enrollment in the study, patients were followed for a minimum of 12 months and a maximum of 30 months. Secondary endpoints included measures of neurological outcome and disease progression.

Clinical Trial Results

The Phase III study results demonstrated about a 30 percent improvement in survival rates and neurological symptoms in patients who received GLIADEL(R) Wafer therapy. 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 significant benefit in the GLIADEL(R) Wafer treatment group.

"Implanted at the time of initial surgery, GLIADEL(R) Wafer offers patients the benefits of localized chemotherapy without the devastating side effects of systemic treatments, while offering the hope of extended survival and delayed onset of neurological deterioration," said Alan Hamilton, MD, Chief, Division of Neurosurgery, University of Arizona Health Sciences Center.

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.

GLIADEL(R) Wafer received marketing approval from the FDA in September 1996 to treat recurrent glioblastoma multiforme (GBM), an aggressive form of malignant brain cancer. Prior to the availability of GLIADEL(R) Wafer, standard of care for GBM patients was removal of the tumor followed by radiation and systemic chemotherapy.

About GBM

Primary brain tumors are tumors that originate in the brain. Astrocytoma, medulloblastoma and GBM are examples of primary brain tumors. GBM is considered one of the most rapidly progressive and universally fatal of all cancers. According to the American Brain Tumor Association, there are approximately 17,500 primary brain tumors diagnosed in the United States each year. Of these, GBM is the most common type. Even with aggressive conventional treatment the typical patient lives less than one year after diagnosis.

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.

Conference Call

Guilford will host a conference call to review the ODAC Panel Meeting. The conference call will take place at 9:00 a.m. E.T. on Friday, December 7, 2001. The dial in number is (212) 346-7427.

Conference Call Replay

An audio replay of the conference call will be available for 24 hours from 11:00 a.m. ET on December 7, 2001 through 11:00 a.m. December 8, 2001. To access the replay, dial 1-800-633-8284, (int'l callers 858-812-6440), then dial reservation number 20078296.

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 FDA will follow ODAC's recommendation and approve GLIADEL(R) Wafer for initial therapy in patients newly diagnosed with malignant glioma.