ASX-listed IDT Australia Limited has been awarded a five-year contract valued at $3.2 million for the manufacture of NPI-001 tablets, an investigational treatment for retinitis pigmentosa (RP), a degenerative eye disease that can lead to vision loss.
The agreement was awarded by Nacuity Pharmaceuticals Pty Ltd and includes the current Good Manufacturing Practice (cGMP) production of the therapy’s active pharmaceutical ingredient (API) and finished dosage form.
The initial statement of work is expected to be completed by the end of FY2026, with provisions for annual follow-up contracts, IDT said in an ASX announcement.
Manufacturing activities are already underway at IDT’s recently recommissioned 4,000-litre cGMP manufacturing plant, which the company says is now the largest small molecule API facility in Australia.
According to IDT, the project involves a tenfold scale-up in production of the API to approximately 200 kilograms and the manufacture of around one million tablets of NPI-001.
Paul McDonald, Chief Executive Officer of IDT Australia, said the company is “excited to partner with Nacuity Pharmaceuticals Pty Ltd on the manufacture of this promising therapy for patients with RP, especially when there is no standard treatment for the disease.”
“Our ability to support innovative clients from clinical trials to commercialisation is one reason why we have such a high rate of return work,” he said.
Nacuity Pharmaceuticals CEO Halden Conner said the company chose to work with IDT Australia due to its “world-class manufacturing facilities and unique ability to support our development program from clinical trials to commercial scale-up.”
NPI-001 (N-acetylcysteine amide) has received Fast Track designation from the U.S. Food and Drug Administration, recognising its potential to address an unmet medical need and expedite its development and regulatory review.
IDT said the recommissioning of its API facility also enhances its ability to address large-scale manufacturing demands and contribute to mitigating potential drug shortages.
