FREDERICTON – A New Brunswick-based pharmaceutical company has been granted a designation for its ovarian cancer treatment by the U.S. Food and Drug Administration (FDA).
The FDA granted orphan-drug designation to Soricimed Biopharma Inc’s peptide SOR-C13 for the treatment of ovarian cancer. Soricimed Biopharma Inc. is a clinical-stage pharmaceutical company discovering and developing peptide-based cancer therapeutics.
“Receiving orphan drug status is significant”, stated Paul Gunn, President and CEO at Soricimed. “It is an important regulatory milestone, offering special incentives to Soricimed through the development stage of SOR-C13.”
Orphan drug status is granted following review of the rarity and severity of the medical condition, as well as the potential benefit of the product treating this condition. Orphan drug status qualifies Soricimed for various development incentives, including tax credits and reduced filing fees for clinical trials undertaken in the U.S. If approved for commercialization by the FDA, SOR-C13 may qualify for seven years of marketing exclusivity in the United States.
Soricimed announced that it had reached its target enrollment and treatment duration in its Phase 1 trial of SOR-C13 in patients with solid tumour cancers who had failed other treatments. Topline results were released last month.
In February, Soricimed’s office in Sackville was damaged by a fire.