AFT update on Maxigesic IV(R) US registration filing

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





2 September 2022
AFT update on Maxigesic IV
®
US registration filing
AFT Pharmaceuticals (NZX: AFT, ASX: AFP) today updates investors on its programme
to obtain US Food and Drug Administration (FDA) registration of Maxigesic IV, the
intravenous form of its patented pain relief medicine.
Alongside its Maxigesic IV development partner Hyloris Pharmaceuticals, AFT is
planning to commence additional studies to answer the FDA’s July 2022 request for
further information on Maxigesic IV’s packaging.
The studies – to provide further data on extractables and leachables from the
packaging – are expected to commence before the end of this year and are due to
complete in the new year. AFT will then file with the FDA once the studies are
complete.
AFT Managing Director Dr Hartley Atkinson said: “AFT and Hyloris are focussed on
Maxigesic IV fulfilling the significant commercial potential we see for the medicine in
the world’s largest pharmaceutical market. We are looking forward to giving the FDA
the requested additional data.”
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 currently licensed in more than 100
countries across the globe. It has also been registered in 41 countries and launched
in 10 countries including Australia, France, Germany, Indonesia and Korea. The
medicine is protected by a number of granted patents and pending patent
applications which extend until 2035-2038.

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

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

About AFT Pharmaceuticals


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 to out-license / distribute our products to local licensees and distributors
to over 125 countries around the world. For more information about the company, visit
our website www.aftpharm.com.