AFT Pharmaceuticals Enters Late-Stage R&D for Novel Injectable
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AFT Pharmaceuticals (search) has partnered with two European entities to advance a novel injectable medicine through late-stage research and development.
The agreement includes a Phase III clinical trial involving approximately 1,000 patients to confirm the medicine's efficacy and safety.
AFT will share the clinical trial costs and will participate in profits from sales and out-licensing activities globally, pending successful trials and commercialization.
AFT Pharmaceuticals (search) (NZX: AFT, ASX: AFP) has announced a collaborative agreement with two European partners to finalize the research and development of a novel injectable medicine. This injectable features a patented New Chemical Entity (NCE). The partnership aims to conduct a confirmatory Phase III clinical trial involving approximately 1,000 patients to rigorously assess the medicine's efficacy and safety profile.
The agreement stipulates that AFT will equally share the costs of the Phase III trial with one of its European partners. Upon successful completion of the trial and subsequent commercialization, AFT is set to receive a share of the profits from all territories where the medicine is sold, as well as income derived from out-licensing activities. The partners anticipate launching the medicine within three years, with potential revenue from out-licensing preceding on-market sales.
The specific condition treated by the medicine remains confidential. However, it is designed for a global market anticipated to expand from approximately US$3 billion in 2024 to over US$7 billion by 2033. The injectable is administered as a single dose for most patients, potentially offering a significant advantage over current treatments that typically require two injections.
One of the partners has already developed the product to its current stage. AFT and the remaining partner will collaborate to complete the development, registration, and commercialization processes worldwide. The involved partners have requested that their identities remain confidential.
AFT Managing Director and CEO Hartley Atkinson commented, “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.”
The agreement is contingent upon the partners achieving a satisfactory meeting with both the European Medicines Agency (EMA) and the US FDA before March 31, 2025. It also requires final confirmation of Freedom to Operate for the manufacturing operation responsible for producing the medicine. AFT has committed to providing updates to the market as these conditions are met.