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."
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Monday, September 27, 2004
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