Guilford Pharmaceuticals Inc has been informed by the United States Food and Drug Administration (FDA) that Gliadel Wafer (polifeprosan 20 with carmustine implant), the Company's proprietary brain cancer treatment, was entitled to seven years of market exclusivity for the treatment of patients with malignant glioma undergoing primary surgical resection. The seven-year period of exclusivity under the Orphan Drug Act commenced on the date of approval in February 2003 and extends until February 2010.

The FDA's orphan drug programme is intended to encourage research, development and approval of products for diseases that affect fewer than 200,000 patients in the United States per year and provide a significant therapeutic advantage over existing treatments.

Craig R Smith. president and CEO, Guilford Pharmaceuticals stated, "In August, we reported that Gliadel had been assigned to a new Diagnosis Related Group (DRG) by the Centres for Medicare and Medicaid Services. The new DRG, which will take effect on October 1, 2004, is expected to improve access to Gliadel by providing increased payment to hospitals that provide it to their Medicare patients. In addition, last week we reported that Gliadel had received marketing authorization in Europe."

"Our patent protection for Gliadel ends in August 2006. Orphan Drug Designation for Gliadel gives us an additional four years of market exclusivity in the United States for patients undergoing primary surgical resection," continued Dr. Smith. "While we believe our manufacturing process for Gliadel is sufficiently complex to deter others from making the product, this new period of exclusivity ensures they cannot market it for this indication," he concluded.

Gliadel Wafer is the only marketed cancer treatment capable of delivering chemotherapy directly to the site of a brain tumour, bypassing the blood-brain barrier and 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.

Guilford Pharmaceuticals Inc is a pharmaceutical company engaged in the research, development and commercialization of proprietary drugs that target the hospital and neurology markets.