Independent tests have shown PharmAust’s Monepantel (MPL) anti-cancer drug retains long-term shelf life and product stability.

The Good Manufacturing Practice (GMP) grade stability study conducted independently by Catalent Pharma Solutions (NYSE:CTLT) was for a storage period of at least 12 months.

GMP is a globally recognised standard which requires rigorous, controlled and documented processes to provide fully-characterised drugs with the highest levels of purity for safe and effective administration to patients – and meets the standards required for clinical trials in Australia, the United States and Europe.

GMP tablet reduces costs and risks

It’s kind of a big deal for the biotechnology company, as it moves towards Phase 2 human trials and identifies potential commercial partners.

“We are delighted with the latest stability achievements in the development of monepantel,” PharmAust (ASX:PAA) executive chairman Dr Roger Aston said.

“Having a robust GMP tablet significantly reduces costs and risk associated with repeat manufacturing programs and provides more certainty for PharmAust’s clinical trial scheduling.”

FightMND milestone payment

PharmAust (ASX:PAA) teamed up with Aussie charity organisation, FightMND, a few years ago to conduct research into Motor neurone disease (MND) with the help of a $900k grant.

With the completion of this 12-month GMP Stability Study, the next instalment of $118,926.80 is now payable, the company says.

A further $138,134.80 will be payable upon the completion of Cohort 3 which is expected next month, and $150,142.80 will be payable upon the completion of Cohort 4 which is expected in July 2023.




This article was developed in collaboration with PharmAust Limited, a Stockhead advertiser at the time of publishing.


This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.