AFT Pharmaceuticals (ASX: AFP) has entered into an agreement with two European partners to complete a late-stage research and development programme for a novel injectable medicine containing a patented New Chemical Entity (NCE).
The conditional agreement envisages AFT undertaking a final confirmatory Phase III clinical trial of the medicine involving approximately 1,000 patients. The trial is aimed at confirming the efficacy of the medicine and its safety. The development plan also envisages the partners bringing the medicine to market within three years with income from out-licensing being potentially booked prior to on-market sales.
Costs of the clinical trial will be equally shared between AFT and one of the European partners.
Upon the successful conclusion of the trials and commercialisation of the medicine, AFT will share in the profits in all territories where it is sold and any income from out-licensing activities.
The medicine, and the condition it treats, presently remain confidential, but it is targeted at a global market that is forecast to grow from around US$3 billion in 2024 to more than US$7 billion in 2033. The medicine is delivered as single dose for the majority of patients, offering potential advantages over existing treatments, which generally require two injections.
One partner has developed the product to date to this stage and AFT and the remaining partner will complete the development, registration and commercialisation of the product around the globe. The partners to the agreement have requested confidentiality.
“This is an exciting project that offers us rapid entry into a highly attractive and significant global market. It also rounds out our research and development pipeline, which now positions the company well to significantly build on our enduring record of consistent long-term growth,” AFT Managing Director and CEO, Hartley Atkinson, said.
The agreement is conditional on the partners concluding a satisfactory European Medicines Agency (EMA) and a US FDA meeting prior to 31 March 2025 and additionally final confirmation of Freedom to Operate for a manufacturing operation required to manufacture the medicine.
