AFT welcomes US FDA approval for sale of Maxigesic IV

AFT Pharmaceuticals Limited, Level 1, 129 Hurstmere Road, Takapuna, Auckland 0622, New Zealand
Incorporated in New Zealand ARBN:
ARBN 609 017 969 investor.relations@aftpharm.com





18
th
October 2023
AFT welcomes US FDA approval for sale of Maxigesic IV
®


AFT Pharmaceuticals (NZX: AFT, ASX: AFP) today announces it has been notified
overnight that the US FDA has approved Maxigesic IV
®
, the intravenous form of its
patented pain relief medicine, for sale in the US, which represents AFT’s second FDA
approval within one year.
The medicine is now positioned to go on sale either at the tail end of FY’24 or early in
FY’25, an event that will trigger a milestone payment of US$6 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 Hyloris. AFT also qualifies for a US$2.9 million
reimbursement of regulatory fees paid to the FDA for Maxigesic IV that it expects to
receive in the current financial year.
If the commercial milestone for the launch of Maxigesic IV is triggered within this
financial year (FY’24) then this license income will be in addition to the current $22-
24m guidance.
AFT Co-Founder and Managing Director Dr Hartley Atkinson says: “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
1
. 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 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.,” Dr Atkinson said.
“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.”
Maxigesic IV is a novel, unique combination, intravenous formulation for the treatment
of post-operative pain that aims to provide an effective alternative to opioid pain
relief medicines, offering a significant alternative therapeutic option. Maxigesic Rapid

1
Statista

AFT Pharmaceuticals Limited, Level 1, 129 Hurstmere Road, Takapuna, Auckland 0622, New Zealand
Incorporated in New Zealand ARBN:
ARBN 609 017 969 investor.relations@aftpharm.com

offers similar benefits, which AFT is still working through the best way to approach the
US market for this dose form of the medicine.
In the United States chronic opioid usage in patients following surgery averaging
around 9%, which is a concern
2
. Drug overdoses involving opioids meanwhile resulted
in over 80,000 deaths in the US in 2021
3
. Patients who experienced an opioid overdose
accounted for nearly US$2 billion in annual hospital costs
4
.
Maxigesic was invented by Dr Atkinson and was first introduced in New Zealand in
2009 in tablet form. The medicine has since been licensed in more than 100 countries
worldwide and is sold in a variety of dose forms in 62 countries.
Released for and on behalf of AFT Pharmaceuticals limited by Malcolm Tubby, Chief
Financial Officer.

For more information:
Investors Media
Dr Hartley Atkinson Richard Inder
Managing Director The Project
AFT Pharmaceuticals Tel: +64 21 645 643
Tel: +64 9488 0232

About AFT Pharmaceuticals www.aftpharm.com
AFT Pharmaceuticals are a growing multinational pharmaceutical company that
develops, markets, and distributes a broad portfolio of pharmaceutical products
across a wide range of therapeutic categories which are distributed across all major
pharmaceutical distribution channels: over the counter, prescription, and hospital.
AFT Pharmaceutical's product portfolio comprises both proprietary and in -licensed
products, and includes patented, branded, and generic drugs.



2
Chronic Opioid Usage in Surgical Patients in a Large Academic Center - PubMed (nih.gov)
3
Data Overview | Opioids | CDC
4
Premier | Opioid Overdoses Costing U.S. Hospitals an Estimated $11... (premierinc.com)