GlycoMimetics today said that the United States Patent and Trademark Office has issued a patent for GMI-1359, covering composition of matter as well as pharmaceutical formulations, and will provide protection through 2035, excluding any patent term adjustments or extensions.
“The new patent for GMI-1359 will help protect the composition of matter of this innovative approach in oncology. GMI-1359 may have a role in treating rare pediatric cancers, such as osteosarcoma, as well as breast cancer and other solid tumors that metastasize to bone,” stated Rachel King, Chief Executive Officer of GlycoMimetics. “This intellectual property, as well as that previously granted in Europe, will play a key role as the company advances the drug candidate, especially with the new orphan and rare pediatric disease designations granted by the FDA.”
New FDA Designations
In parallel, GlycoMimetics today announced that the FDA has granted Orphan Drug Designation and Rare Pediatric Disease Designation to GMI-1359 for the treatment of osteosarcoma, a rare cancer affecting about 900 adolescents a year in the United States. These designations will aid in the development of this drug candidate, including making it eligible for the FDA’s Pediatric Priority Review Voucher.