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Guilford Pharmaceuticals Announces Orphan Drug Designation for GLIADEL(R) Wafer

Posted on: 09/27/2004

Guilford Pharmaceuticals Announces Orphan Drug Designation for GLIADEL(R) Wafer

Market Exclusivity for GLIADEL(R) Extends Until 2010

BALTIMORE, Sept. 27 /PRNewswire-FirstCall/ -- Guilford Pharmaceuticals Inc. (Nasdaq: GLFD) today announced that it has received notice from the United States Food and Drug Administration (FDA) that GLIADEL(R) Wafer (polifeprosan 20 with carmustine implant), the Company's proprietary brain cancer treatment, is entitled to seven years of market exclusivity for the treatment of patients with malignant glioma undergoing primary surgical resection. The seven-year period of exclusivity under the Orphan Drug Act commenced on the date of approval in February 2003 and extends until February 2010.

The FDA's orphan drug program is intended to encourage research, development and approval of products for diseases that affect fewer than 200,000 patients in the United States per year and provide a significant therapeutic advantage over existing treatments.

"Today's news is the latest in a series of positive developments for GLIADEL(R) announced over the last several weeks," commented Craig R. Smith. M.D., President and Chief Executive Officer. "In August, we reported that GLIADEL(R) had been assigned to a new Diagnosis Related Group (DRG) by the Centers for Medicare and Medicaid Services. The new DRG, which will take effect on October 1, 2004, is expected to improve access to GLIADEL(R) by providing increased payment to hospitals that provide it to their Medicare patients. In addition, last week we reported that GLIADEL(R) had received marketing authorization in Europe."

"Our patent protection for GLIADEL(R) ends in August 2006. Orphan Drug Designation for GLIADEL(R) gives us an additional four years of market exclusivity in the United States for patients undergoing primary surgical resection," continued Dr. Smith. "While we believe our manufacturing process for GLIADEL(R) is sufficiently complex to deter others from making the product, this new period of exclusivity ensures they cannot market it for this indication."

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 For full prescribing information, please see, under Products / Marketed Products / GLIADEL(R) Wafer.

Important Information About GLIADEL(R) Wafer
GLIADEL(R) Wafer is indicated in newly diagnosed patients with high-grade malignant glioma as an adjunct to surgery and radiation. GLIADEL(R) Wafer is also indicated in recurrent glioblastoma multiforme patients as an adjunct to surgery.
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. 6%) 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, 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 August 9, 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 Company will be able to maintain or increase sales of GLIADEL(R) Wafer, either in the United States or in Europe.
SOURCE Guilford Pharmaceuticals Inc.
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