Guilford Pharmaceuticals Announces Orphan Drug Designation for GLIADEL(R) Wafer; Market Exclusivity for GLIADEL(R) Extends Until
September 27 2004 - 9:33AM
PR Newswire (US)
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, +1-410-631-5022 Web site:
http://www.gliadel.com/ Web site: http://www.guilfordpharm.com/
Company News On-Call: http://www.prnewswire.com/comp/112882.html
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