AFT Secures Late-Stage R&D Agreement for Novel Injectable Treatment
Monday, October 21, 2024
AFT Pharmaceuticals has announced a partnership with two European companies to finalise the research and development of a novel injectable medicine containing a patented New Chemical Entity (NCE).
The agreement, which is conditional, includes a confirmatory Phase III clinical trial involving around 1,000 patients. This trial aims to verify the medicine's efficacy and safety.
The product has been developed to its current stage by one partner, while AFT and the other partner will complete its development, registration, and global commercialisation.
The development plan outlines bringing the medicine to market within three years, with potential income from out-licensing activities prior to market launch.
AFT and one of its European partners will share the trial costs equally. Upon successful trial completion and commercialisation, profits from all territories and any out-licensing revenues will be shared.
The specifics of the medicine and the condition it treats remain confidential, but the targeted global market is expected to grow from approximately US$3 billion in 2024 to over US$7 billion by 2033.
The medicine is designed to be administered as a single dose for most patients, offering an advantage over existing treatments that typically require two injections.
The agreement’s conditions include satisfactory meetings with the European Medicines Agency (EMA) and the US FDA by 31 March 2025, as well as final confirmation of Freedom to Operate for a required manufacturing operation.
Source: aftpharm.com
