Maxigesic IV launched in the United States

AFT Pharmaceuticals (NZX: AFT, ASX: AFP) announces Maxigesic IV®, the patented intravenous form of its family of pain relief medicines, has today been 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 (estimated at around NZ$6 million).1

The company is currently in its usual month-end preparation and review of progress and projections for FY2024 (being for the year ending 31 March 2024) and expects to update the market on its FY2024 guidance within a fortnight once this process is completed.

“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 finalization 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.

Hikma President of Injectables Dr Bill Larkins said: “The approval of Combogesic® IV is an important step in providing hospitals and health care providers in the US with an alternative treatment option for managing patients’ pain.

“This is another example of how we continue to expand our portfolio of critical medicines and we are pleased to make this important new treatment option available for patients, helping to put better health within reach, every day.”

Hikma’s announcement of the launch of Maxigesic IV is attached to this announcement.

Maxigesic IV is licensed in over 100 countries and marketed in over 20. It offers a unique combination of 1,000 mg of acetaminophen (paracetamol) and 300 mg of ibuprofen. This combination of medicines with different mechanisms of action in a single formulation provides:

  • Shorter onset to analgesia3
  • Superior analgesia efficacy and comparable safety in common adverse events2
  • Sustained pain-management results2

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.2 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.2

Released for and on behalf of AFT Pharmaceuticals limited by Malcolm Tubby, Chief Financial Officer.

For more information:

Investors

Dr Hartley Atkinson
Managing Director
AFT Pharmaceuticals
Tel: +64 9488 0232

Media
Richard Inder
The Project
Tel: +64 21 645 643

1 As previously disclosed, AFT’s practice is to exclude the benefit of one-off milestone payments of this nature in guidance.
2 https://www.mordorintelligence.com/industry-reports/pain-management-market
3 Daniels SE, Playne R, Stanescu I, Zhang J, Gottlieb IJ, Atkinson HC. Efficacy and safety of an intravenous acetaminophen/ibuprofen fixed-dose combination after bunionectomy: A randomized, double-blind, factorial, placebo-controlled trial. Clinical Therapeutics. 2019;41(10).