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 http://www.gliadel.com. For
full prescribing information, please see 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
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.
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.
SOURCE Guilford Pharmaceuticals Inc.