September 28, 2004

GLIADEL WAFER GAINS ORPHAN DRUG DESIGNATION

Guilford Pharmaceuticals Inc. received an orphan drug designation from the Food and Drug Administration for its currently marketed brain cancer treatment Gliadel Wafer (polifeprosan 20 with carmustine implant).

The designation applies to Gliadel's use in the treatment of patients with malignant glioma who are undergoing primary surgical resection.

Guilford said it believes the manufacturing process for Gliadel is sufficiently complex to deter other firms from manufacturing generic versions, but the orphan designation ensures such formulations cannot be marketed for the specified indication.

Orphan status grants Guilford a seven-year period of exclusivity, beginning on the date of approval, which came in February of last year. Guilford's patent protection for pharmaceutical name Gliadel expires in August 2006; orphan status will extend exclusivity to February 2010.

Gliadel is implanted in the cavity created by surgical removal of a brain tumor. Up to eight wafers may be implanted, where they dissolve, slowly releasing carmustine directly to the tumor site.

The pharma brand drug was first approved by the FDA in 1996 for the treatment of patients undergoing a second surgery following recurrence of glioblastoma multiforme, another form of brain cancer.