BALTIMORE, MD (Sept. 14, 2004) – Guilford Pharmaceuticals Inc. announced that its proprietary treatment for brain cancer, Gliadel 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 has been approved for use in the following countries: France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain and the United Kingdom, the company said.
Gliadel previously was authorized for use only in recurrent surgery for glioblastoma multiforme.
Gliadel 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. The wafer complements other standardtherapies for brain cancer, such as surgery, radiation and intravenous chemotherapy, the company said.
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-grademalignant 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 and 2 received placebo. Survival was prolonged in the Gliadel treatment group (median survival increased to 13.9 months from 11.6 months). The overall risk of dying during 3-4 years after treatment was reduced in the Gliadel treatment group, the company said.
Gliadel received approval from the U.S. Food & Drug Administration in February 2003 for use in newly diagnosed patients with high-grade malignant glioma as an adjunct to surgery and radiation. Guilford has entered intodistribution agreements with the following European pharmaceutical companies to market and sell Gliadel in Europe: Link Pharmaceuticals Ltd., Laboratorios del Dr. Esteve S.A., Orion Farmos, Dompe Farmaceutici s.p.a., and Genesis Pharma S.A.
In May 2004, Guilford granted Link exclusive rights to market, sell and distribute Gliadel in Germany, France, Benelux, Austria and Switzerland. This is in addition to Link’s exclusive rights in the United Kingdom, granted in June 2002.
Under its agreement with Link, Guilford will receive a $750,000 milestone payment from Link based on approval for initial surgery in France and Germany.
Guilford Pharmaceuticals is engaged in the research, development and commercialization of proprietary drugs that target the hospital and neurology markets.