Pharma Focus Europe

Fennec Pharmaceuticals Announces PEDMARKĀ® (sodium thiosulfate injection) Receives Orphan Drug Exclusivity from U.S. FDA

Wednesday, February 01, 2023

Fennec Pharmaceuticals Inc., a commercial stage specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Exclusivity to PEDMARK® (sodium thiosulfate injection), which is indicated to reduce the risk of ototoxicity, or hearing loss, associated with cisplatin use in pediatric patients one month of age and older with localized, non-metastatic solid tumors.

The FDA’s Orphan Drug Designation program is designed to advance the development of drugs that treat a condition affecting 200,000 or fewer U.S. patients annually. The seven-year market exclusivity for PEDMARK® began on September 20, 2022, the date of its FDA approval, and continues until September 20, 2029. Additionally, in the approved prescribing label, the FDA has explicitly directed that PEDMARK® is not substitutable with other sodium thiosulfate products.1

“We are pleased that the FDA has granted Orphan Drug Exclusivity to PEDMARK®, which represents an important breakthrough treatment option for the pediatric cancer community,” said Rosty Raykov, chief executive officer of Fennec Pharmaceuticals. “Further, as the first and only FDA approved drug for the treatment of pediatric cancer patients with localized, non-metastatic solid tumors at risk for cisplatin-induced hearing loss, we will continue to focus on strengthening our patent portfolio to extend intellectual property protection for PEDMARK® beyond the seven years provided with Orphan Drug Exclusivity.”

In addition to Orphan Drug Exclusivity, PEDMARK® currently has three Orange Book listings for U.S. Patent No. 11,291,728 (‘728) and U.S. Patent No. 11,510,984 (‘984) that covers PEDMARK® pharmaceutical formulation and U.S. Patent No. 10,156,190 (‘190), which relates to a method of use for our PEDMARK® product. The ‘728 and ‘984 patents expire in 2039 and the ‘190 patent expires in 2038.

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