GLFD Guilford Pharmaceuticals (MM)

Guilford Pharmaceuticals' GLIADEL(R) Wafer Assigned New DRG Designation BALTIMORE, Aug. 3 /PRNewswire-FirstCall/ -- Guilford Pharmaceuticals Inc. (NASDAQ:GLFD) today announced that GLIADEL(R) Wafer (polifeprosan 20 with carmustine implant), the Company's proprietary brain cancer treatment, has been assigned to a new Diagnosis Related Group (DRG) by the Centers for Medicare and Medicaid Services (CMS). The new DRG, DRG 543, Implantation of Chemotherapeutic Agents or Acute Complex Central Nervous System Principal Diagnosis, will take effect on October 1, 2004 and is expected to improve access to GLIADEL(R) Wafer by providing increased payment to hospitals that provide the product to Medicare beneficiaries. GLIADEL(R) Wafer is approved for use in newly diagnosed patients with high-grade malignant glioma as an adjunct to surgery and radiation, and in patients with recurrent glioblastoma multiforme as an adjunct to surgery and radiation. Craig R. Smith, M.D., President and Chief Executive Officer of Guilford, commented, "The new DRG is a major step forward for the treatment and care of patients with brain tumors, and reflects the strong, continuing support from neurosurgeons, patients and patient advocacy groups for the product. We believe that the new designation more appropriately recognizes hospitals' resource utilization in providing GLIADEL(R) Wafer and will further increase the medical community's adoption of this innovative therapy for patients with high-grade malignant brain cancer." About GLIADEL(R) Wafer GLIADEL(R) Wafer is the only marketed cancer treatment capable of delivering chemotherapy directly to the site of a brain tumor, bypassing the blood-brain barrier and minimizing drug exposure to other areas of the body. GLIADEL(R) 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. Up to eight GLIADEL(R) Wafers can be implanted in the cavity created when a surgeon removes a brain tumor. There, they slowly dissolve, releasing BCNU directly to the tumor site in high concentrations, while minimizing drug exposure to other areas of the body. Additional information on GLIADEL(R) Wafer is available at http://www.gliadel.com/. For full prescribing information, please see http://www.guilfordpharm.com/, under Products / Marketed Products / GLIADEL(R) Wafer. Important Information About GLIADEL(R) Wafer The following four categories of adverse events are possibly related to treatment with GLIADEL(R) Wafer during initial resection. Frequencies are listed of events that occurred in a randomized trial of GLIADEL(R) Wafer and placebo, respectively: seizure (33.3% vs 37.5%); brain edema (22.5% and 19.2%); healing abnormalities (15.8% vs 11.7%); and intracranial infection (5.0% vs 6.0%). The following three categories of adverse events are possibly related to treatment with GLIADEL(R) Wafer for recurrent disease. Frequencies are listed of events that occurred in a randomized trial of GLIADEL(R) Wafer and placebo, respectively: post-operative seizure (19% vs 19%); healing abnormalities (14% vs 5%); intracranial hypertension (4% vs 4%) and intracranial infection (4% vs 1%). Patients undergoing craniotomy for malignant glioma and implantation of GLIADEL(R) Wafer should be monitored closely for known complications of craniotomy, including seizures, intracranial infections, abnormal wound healing, and brain edema. Cases of intracerebral mass effect unresponsive to corticosteroids have been described in patients treated with GLIADEL(R) Wafer, including one case leading to brain herniation. GLIADEL(R) Wafer contains carmustine and should not be given to patients who are allergic to carmustine. Carmustine can also cause fetal harm when administered to a pregnant woman. The short and long-term toxicity profiles of GLIADEL(R) Wafer when given in conjunction with radiation or chemotherapy have not been fully explored. About Guilford Guilford Pharmaceuticals Inc. is a pharmaceutical company engaged in the research, development and commercialization of proprietary drugs that target the hospital and neurology markets. Presently, Guilford markets two commercial products, GLIADEL(R) Wafer (polifeprosan 20 with carmustine implant), for the treatment of brain cancer, and AGGRASTAT(R) Injection (tirofiban hydrochloride), a glycoprotein GP IIb/IIIa receptor antagonist for the treatment of acute coronary syndrome (ACS). Guilford's product pipeline includes a novel anesthetic, AQUAVAN(R) Injection, and drugs for treating Parkinson's disease and peripheral nerve injury. For additional prescribing information about GLIADEL(R) and AGGRASTAT(R) please see http://www.guilfordpharm.com/, under Products / Marketed Products. Contact: Guilford Pharmaceuticals Inc. Stacey Jurchison 410.631.5022 This press release contains forward-looking statements that involve risks and uncertainties, including those described in the section entitled "Risk Factors" contained in the Company's Quarterly Report on Form 10-Q filed with the SEC on May 10, 2004, and in the Company's Current Report on Form 8-K filed with the SEC on June 21, 2004, that could cause the Company's actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. Among other things, there can be no assurance that the assignment of GLIADEL(R) Wafer to a new DRG will result in an increase in physicians prescribing GLIADEL(R) Wafer for their patients or in an increase in sales of the product. DATASOURCE: Guilford Pharmaceuticals Inc. CONTACT: Stacey Jurchison of Guilford Pharmaceuticals, +1-410-631-5022 Web site: http://www.guilfordpharm.com/ http://www.gliadel.com/ Company News On-Call: http://www.prnewswire.com/comp/112882.html

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