Guilford Pharmaceuticals Receives European Marketing Authorization for Expanded Use of GLIADEL(R) Wafer

Guilford Pharmaceuticals Receives European Marketing
Authorization for Expanded Use of GLIADEL(R) Wafer
GLIADEL(R) Approved to Treat Newly-Diagnosed Patients with Malignant Glioma



BALTIMORE, Sept. 14  /PRNewswire-FirstCall/ -- Guilford Pharmaceuticals Inc.
(NASDAQ:GLFD) today announced that its proprietary treatment for brain cancer,
GLIADEL(R) Wafer (polifeprosan 20 with carmustine implant), has been granted
extended marketing authorization in Europe to include use in newly- diagnosed
patients with high-grade malignant glioma as an adjunct to surgery and
radiation.  Under the mutual recognition procedure, GLIADEL(R) has been
approved for use in the following countries: France, Germany, Greece, Ireland,
Italy, Luxembourg, Netherlands, Portugal, Spain and the United Kingdom.
GLIADEL(R) was previously authorized for use only in recurrent surgery for
glioblastoma multiforme.

GLIADEL(R) 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) complements other standard therapies for
brain cancer, such as surgery, radiation and intravenous chemotherapy.

The European approval was based on favorable data from a randomized,
double-blind, placebo-controlled Phase III clinical trial that enrolled 240
adult men and women undergoing initial surgical resection of a high-grade
malignant glioma in 38 centers in 14 countries.  Complete follow-up for as long
as 48 months was obtained for 239 of the 240 patients.  Of the 11 patients
known to be alive on the date of last follow up, 9 received GLIADEL(R) and 2
received placebo.  Survival was prolonged in the GLIADEL(R) treatment group
(median survival increased to 13.9 months from 11.6 months, p