Business
Medexus Announces FDA Approval of GRAFAPEX (treosulfan) for Injection and Provides Business Update
Medexus will target a commercial launch in 1H CY2025; potential for annual product-level revenue ...
About this update from Medexus Pharmaceuticals Inc.
[{"type":"text","content":"Medexus Announces FDA Approval of GRAFAPEX (treosulfan) for Injection and Provides Business UpdateMedexus will target a commercial launch in 1H CY2025; potential for annual product-level revenue to exceed US$100 million within five years after commercial launchToronto, Ontario and Chicago, Illinois--(Newsfile Corp. - January 22, 2025) - Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) is pleased to provide a business update regarding the successful completion of the regulatory review process for GRAFAPEX™ (treosulfan) for injection with the US Food and Drug Administration and, in addition, to announce preliminary estimates of the company's operating and financial results for the company's third fiscal quarter ended December 31, 2024 (which remain subject to completion of Medexus's financial closing procedures). All dollar amounts in this news release are in US dollars unless specified otherwise.FDA approval of GRAFAPEX™ (treosulfan) for injectionOn January 22, 2025, Medexus was informed that the FDA approved GRAFAPEX™, an alkylating agent, with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult and pediatric patients one year of age and older with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). GRAFAPEX™ holds Orphan Drug Designation under the Orphan Drug Act, meaning that the product will benefit from up to seven-and-a-half years of regulatory exclusivity in the FDA-approved indication. Medexus holds exclusive commercial rights to GRAFAPEX™ in the United States under a February 2021 exclusive license agreement with medac GmbH.\"We are pleased to report this positive development, which marks a strategically important step forward for our business and, importantly, will now benefit eligible patients across the United States,\" commented Ken d'Entremont, Medexus's Chief Executive Officer. \"Not only will GRAFAPEX™ make a substantial contribution to alloHSCT in the United States, but it also solidifies Medexus's leadership position in this therapeutic field.\"\"We are targeting a commercial launch in the first half of calendar year 2025, and given our recent experience in Canada we are very optimistic about the potential of GRAFAPEX™ in the US market,\" added Richard Labelle, Medexus's Chief Operating Offic...