Guilford Receives $2.5 Million Milestone Payment for
GLIADEL(R) Wafer in France Baltimore (PROTEXT)
Guilford Pharmaceuticals Inc. (Nasdaq: GLFD) today announced that it has received a $2.5 million milestone payment from Rhone-Poulenc Rorer Pharmaceuticals Inc. (RPR) for regulatory developments relating to GLIADEL(R) Wafer in France. GLIADEL(R) Wafer has been approved for use in France as an adjunct to surgery to prolong survival in patients with recurrent glioblastoma multiforme (GBM), one of the most common and rapidly fatal forms of malignant brain cancer. A positive ruling (avis favorable) has been obtained from the Commission de la Transparence, clearing the way for sale of GLIADEL(R) Wafer to hospitals in France upon publication of the ruling, which is expected later this quarter. "We are strongly committed to expanding the market for GLIADEL(R) Wafer and making it available to more patients worldwide," said Craig R. Smith, M.D., President and Chief Executive Officer. "In June, we announced that GLIADEL(R) Wafer had received a favorable opinion for marketing authorization in ten European countries. We are pleased to report that Ireland and Luxembourg have now granted marketing authorization for the product, and we look forward to receiving notice of additional European marketing authorizations in the coming months." As the first significant new treatment for brain cancer in over 20 years, GLIADEL(R) Wafer is the only marketed cancer treatment capable of delivering chemotherapy directly to the site of a brain tumor, minimizing drug exposure to other areas of the body. GLIADEL(R) Wafer is a biodegradable polymer wafer that is implanted in the cavity created when a brain tumor is surgically removed. As the wafer slowly erodes in the brain, it releases the cancer chemotherapeutic drug carmustine (BCNU) directly to the tumor site in high concentrations over an extended period of time. GLIADEL(R) Wafer offers an important new treatment option for neurosurgeons and complements other standard therapies for brain cancer. In a randomized clinical trial, GLIADEL(R) Wafer was shown to prolong survival in patients with GBM for whom surgical resection is indicated. In a multicenter study involving 145 patients with recurrent GBM, GLIADEL(R) Wafer increased six month survival by more than 50%, from 36% with placebo to 56% with GLIADEL(R) Wafer. In a separate Scandinavian study involving 32 patients undergoing surgery at the time of their initial diagnosis, survival at one year was 63% for GLIADEL(R) Wafer compared to 19% for placebo. Guilford Pharmaceuticals Inc. is a biopharmaceutical company engaged in the development of polymer-based therapeutics for cancer, and novel products for the diagnosis and treatment of neurological diseases, including Parkinson's disease, Alzheimer's disease, stroke, severe head trauma, spinal cord injuries, multiple sclerosis and peripheral neuropathies. The Company desires to take advantage of the "safe harbor" provision of the Private Securities Litigation Reform Act of 1995. This press release contains forward-looking statements that involve risks and uncertainties. The Company describes certain of these risks and uncertainties in its filings with the SEC, including the section entitled "Risk Factors'' contained in the Company's Registration Statement on Form S-3, filed on July 7, 1999. These risk and uncertainties could cause the Company's actual results and experience to differ materially from anticipated results and expectations expressed in these forward- looking statements. In particular, the timing of official publications of regulatory approval, if any, in France and other countries cannot be assured. Furthermore, the Company cannot be sure that any future sales of GLIADEL(R) Wafer in France will be significant, that efforts to obtain additional approvals to market and sell GLIADEL(R) Wafer in other countries for the recurrent or first surgery indications will be successful and permit sales at prices acceptable to the Company and RPR, and that the Company will receive any of the payments from RPR associated with such regulatory milestones. Internet address: http://www.guilfordpharm.com For Press Releases: http://www.prnewswire.com ots Original Text Service: Guilford Pharmaceuticals Inc. Internet: http://www.newsaktuell.de Contact: Stacey Jurchison or Angela Rubin, Corporate Communications of Guilford Pharmaceuticals, (USA) 410-631-6300 Company News On-Call: http://www.prnewswire.com/comp/112882.html or Fax, (USA) 800- 758-5804, ext. 112882 Web site: http://www.guilfordpharm.com
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