Guilford Pharmaceuticals' GLIADEL(R) Wafer Assigned New DRG Designation

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, [phone]



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

http://www.gliadel.com/ 



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