For the second time this year, pharma company AFT Pharmaceuticals (ASX: AFP) has bagged the US Food and Drug Administration’s (FDA) approval. In March 2023, it was approved for Maxigesic Rapid, a rapid-release tablet for acute pain. This time, it’s for Maxigesic IV, the intravenous form of its patented pain relief medicine. The approval was based on clinical trials, and it aims to wean Americans off opioid-based post-treatment pain relief to avoid drug overdoses.
The medicine will go on sale either at the end of FY24 or early FY25. The event will trigger a milestone payment of $9.4 million to AFT from the US licensee of the medicine, Hikma Pharmaceuticals. AFT is entitled to 65% of this under its profit share arrangements with biopharma company Hyloris.
AFT also qualifies for a $4.56 million reimbursement of regulatory fees paid to the FDA for Maxigesic IV that it expects to receive in the current financial year. If Maxigesic IV is commercially launched this year, this license income will be in addition to the Company’s current $22 to 24 million profit guidance.
This would offer some much-needed financial relief as the Company saw its license income fall from over $6.7 million in FY22 to $900k in FY23.
AFT co-founder and managing director, Dr Hartley Atkinson, commented, “We are delighted with the FDA approval of this prescription medicine. We are also proud of the achievement, which is the second approval in one year. The US analgesic market is the world’s largest, worth US$6.83 billion in 2023, and is forecast to grow by an estimated 4.89% a year until 2028. We now have two medicines that can begin to take a share of this market – Maxigesic IV and Maxigesic Rapid®, the rapid-dissolving tablet prescription form of the medicine that was approved by the FDA in March 2023.”
The US witnesses concerning chronic opioid usage in patients following surgery, averaging around 9%. Drug overdoses associated with opioids resulted in over 80,000 deaths in the US in 2021. Besides the cost to life, patients who experienced an opioid overdose accounted for nearly $3.14 billion in annual hospital costs.
Dr Atkinson invented Maxigesic, first introduced in New Zealand in 2009 as a tablet. The medicine has since been licensed in more than 100 countries worldwide and is sold in various dose forms in 62 countries. Maxigesic IV is an intravenous formulation for treating post-operative pain that would otherwise be addressed with less-than-ideal opioid pain relief medicines. Maxigesic Rapid offers similar benefits, and AFT is still working through the best way to approach the US market for this dose form of the medicine.
Atkinson added, “The FDA approval of Maxigesic Rapid was the first time the US food and medicine regulator had given the green light for sale of a New Zealand-developed patented medicine based on clinical trial data. It is a real credit to the determination, commitment, and capability of the AFT team and our research and development partner, Belgium’s Hyloris Pharmaceuticals. We thank them all for their efforts.”
While this approval paves AFT’s path into the US, the Company has also been working towards entering Asian hubs, comprising Singapore and Hong Kong. AFT has 26 planned launches across Australasia in FY24.
Alinda is a Business Reporter for The Sentiment
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