AFT submits Maxigesic IV(R) packaging data to the US FDA

AFT Pharmaceuticals Limited,
Level 1, 129 Hurstmere Road, Takapuna, Auckland 0622, New Zealand
Incorporated in New Zealand ARBN:
ARBN 609 017 969





18 April 2023
AFT submits Maxigesic IV® packaging data to the US FDA
AFT Pharmaceuticals (NZX.AFT, ASX.AFP) today announces it has submitted to the US
Food and Drug Administration (FDA) data the regulator requested as it considers
registration of the company’s patented intravenous pain relief medicine Maxigesic IV.

In a delay to the registration of the medicine in the US, the FDA requested in July 2022
additional data on the performance of Maxigesic IV’s primary packaging (the glass
vial in which the medicine is stored and the vial’s stopper).

AFT along with its commercialisation partner Belgium’s Hyloris Pharmaceuticals has
over the last year collated the data and submitted today.

AFT Managing Director Dr Hartley Atkinson said: “We believe the data we have
submitted will satisfy the FDA’s requirements and remove the outstanding hurdle to
registration. All going well we anticipate registration of the medicine this year and
sales to follow shortly after.”

Maxigesic IV, is a novel, unique combination of 1000mg paracetamol and 300mg
ibuprofen solution for infusion, for the treatment of post-operative pain. It has been
developed in collaboration with Hyloris and is currently licensed in more than 100
countries across the globe. It has also been registered in 43 countries and launched
in 19 countries including Australia, France, Germany, and Korea. The medicine is
protected by several granted patents and pending patent applications.

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

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

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

About AFT Pharmaceuticals

AFT Pharmaceuticals Limited,
Level 1, 129 Hurstmere Road, Takapuna, Auckland 0622, New Zealand
Incorporated in New Zealand ARBN:
ARBN 609 017 969

AFT is 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 (OTC), prescription and hospital. Our product
portfolio comprises both proprietary and in-licensed products, and includes patented,
branded, and generic drugs. Our business model is to develop and in-license products
for sale by our own dedicated sales teams in our home markets of Australia and New
Zealand and in certain Southeast Asian markets, and to out-license our products to
local licensees and distributors to the rest of the world. For more information:
aftpharm.com[