Guilford Pharmaceuticals Announces Orphan Drug Designation for GLIADEL(R) Wafer; Market Exclusivity for GLIADEL(R) Extends Until 2010

Sep 27, 2004, 01:00 ET from Guilford Pharmaceuticals Inc.

    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
     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
     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
     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.