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

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 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

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
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
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. 

DATASOURCE: Guilford Pharmaceuticals Inc.



CONTACT:  Stacey Jurchison, Guilford, [phone]



Web site:  http://www.gliadel.com/ 

Web site:  http://www.guilfordpharm.com/ 



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