Business
Fennec Pharmaceuticals Announces First Quarter 2023 Financial Results and Provides Business Update
~ Strong PEDMARK® Commercial Momentum Building in 2023 with Broad Payor and Medicaid Coverage ~ ~ PEDMARK® Permanent J-Code Effective April 1, 2023 ~ ~ Recent
About this update from Fennec Pharmaceuticals Inc.
[{"type":"text","content":"~ Strong PEDMARK® Commercial Momentum Building in 2023 with Broad Payor and Medicaid Coverage ~ ~ PEDMARK® Permanent J-Code Effective April 1, 2023 ~ ~ Recent Positive CHMP Opinion in EU Recommending Approval of PEDMARQSI™ ~ ~ Company to Host Conference Call Today, Thursday, May 11 at 8:30 a.m. ET ~ RESEARCH TRIANGLE PARK, N.C., May 11, 2023 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company, today reported its financial results for the fiscal quarter ended March 31, 2023 and provided a business update. “During the first quarter, we continued to see strong commercial momentum and uptake of PEDMARK®, further underscoring the significant unmet medical need that exists for pediatric solid tumor cancer patients at risk for developing hearing loss associated with cisplatin treatment. Additionally, we are seeing significant commercial activity in the second quarter as a result of the relationships cultivated with healthcare providers and the pediatric cancer patient community by our commercial team since launch in October 2022,” said Rosty Raykov, chief executive officer of Fennec Pharmaceuticals. “We are pleased with the recent CHMP positive opinion for PEDMARQSI™ and the opportunity to expand PEDMARK’s presence and availability to patients in Europe.” Recent Developments and Highlights: Received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending the approval of PEDMARQSI for reducing the risk of cisplatin-induced hearing loss (Ototoxicity) in pediatric patients with localized, non-metastatic solid tumors.Received notification that the U.S. Centers for Medicare & Medicaid Services (CMS) has issued a permanent J-Code (J0208) for PEDMARK, which became effective April 1, 2023 and will help facilitate the reimbursement process.Broad payor coverage in place with the largest commercial payors and Medicaid coverage in place across all fifty states.The National Comprehensive Cancer Network® (NCCN) updated its clinical practice guidelines for Adolescent and Young Adult (AYA) Oncology to include PEDMARK (sodium thiosulfate injection) in January 2023.The FDA granted Orphan Drug Exclusivity to PEDMARK (sodium thiosulfate injection) in January 2023. The FDA’s Orphan Drug Designation program is designed to adv...