AFT Pharmaceuticals’ (ASX: AFP) Maxigesic IV, the patented intravenous form of its family of pain relief medicines, hasbeen launched in the US by its licensee Hikma Pharmaceuticals.
The launch of the medicine, under the brand Combogesic IV, is the first patented, New Zealand developed medicine with clinical studies in the world’s largest healthcare market. The first commercial sale of the medicine in the US is expected in the coming weeks, a milestone that will trigger a US$6 million licensee fee to AFT and its development partner Belgium’s Hyloris Pharmaceuticals.
AFT expects its share of this license fee to accrue in the current financial year.
“The launch of Maxigesic IV in the US, the world’s largest market for pain relief2, is a significant achievement for AFT,” said AFT Co-Founder and Managing Director Dr Hartley Atkinson.
“We are delighted with the speed with which our partner Hikma, a leading supplier of injectable medicines in the US and around the world, has brought the medicine to market post-approval and the opportunity it shares with us on the potential of the medicine.
“Maxigesic IV represents a significant innovation for the management of pain. It offers effective pain relief and importantly offers clinicians an alternative to opioid analgesics.
“The launch also represents a beachhead for the commercialisation of Maxigesic in the US and potentially our broader portfolio of medicines. Our next goal is the finalisation of plans to launch Maxigesic Rapid, a prescription-only tablet. We have been working on setting up AFT representation in North America in order to support commercialisation with identified partners.”
In a Phase 3 clinical trial, Maxigesic IV provided more than double the pain relief than that of acetaminophen (paracetamol) IV or ibuprofen IV alone. Time to meaningful pain relief was shorter in the Maxigesic IV group than that in the Ibuprofen IV or placebo groups. Maxigesic IV also allowed for superior analgesia efficacy.