Maxigesic(R) Oral Liquid gets first regulatory approval

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





14 July 2021
Maxigesic
®
Oral Liquid gets first regulatory approval
Maxigesic Oral Liquid – a non-opioid analgesic developed for children - achieves
first approval in Europe to set up the first global launch and a pathway for further
registrations and launches.

AFT Pharmaceuticals (NZX; AFT, ASX; AFP) today announces that it has successfully
gained its first regulatory approval of Maxigesic Oral Liquid in Europe (Italy and Malta)
with further regulatory approvals now expected.
Maxigesic Oral Liquid is a novel non-opioid treatment for pain in children between the
ages of 2-12 years. It is a patented unique combination of 160mg paracetamol and
48mg ibuprofen per 5ml oral suspension and is an extension of AFT’s patented
Maxigesic family of medicines.
The registration follows a pivotal clinical safety study in 251 patients in Australia, New
Zealand and Mexico
*¹
between the ages of 2-12, who were treated for up to 11 days
after a tonsillectomy.
AFT Pharmaceuticals Managing Director Dr Hartley Atkinson said: “We are delighted
with the registration of Maxigesic Oral Liquid. It demonstrates the significant potential
of our Maxigesic intellectual property.
“The commercialisation of the tablet version of the medicine is establishing the brand
and acceptance across broad populations around the world. The new dose forms
such as Oral Liquid and the intravenous form Maxigesic IV ® extend the addressable
market and the growth potential for AFT and its global licensee partners.
“The registration of the Oral Liquid version is also a significant achievement because
of the additional regulatory challenges of gaining approval for a medicine targeted
at children.
“This registration now allows an upcoming launch with our partner in Italy, Angelini
Pharma SpA which is exciting as Angelini has made good progress in Italy with the
tablet to date,” said Dr Atkinson.
AFT Pharmaceuticals is making good progress commercialising the Maxigesic family
of medicines around the world. Maxigesic tablets, Maxigesic IV ® and the Oral Liquid
form, are now licensed in more than 100 countries across the globe.
The tablet and intravenous dose forms are registered in 49 and 24 countries,
respectively. Further registrations of these forms as well as the Oral Liquid are expected
in the coming year.

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

The company has also developed a hot drink sachet version of the medicine,
Maxigesic Cold & Flu Hot Drink 'powder for oral liquid sachet'. This dose form gained
its first registration in Australia in April 2021 in two strengths being Paracetamol 1000mg
+ Ibuprofen 300mg and Paracetamol 500mg + Ibuprofen 300mg as over the counter
medicines.
This product has been licensed alongside other oral dose forms of Maxigesic in over
100 countries, while the first launch for this product is planned in the current financial
year in Australia where Maxigesic is the largest selling paracetamol and ibuprofen
combination product in units and dollars/value*².
For and on behalf of AFT Pharmaceuticals Limited, Malcolm Tubby, CFO
*¹ Playne R et al. Analgesic effectiveness, pharmacokinetics and safety of a
paracetamol/ibuprofen fixed-dose combination in children undergoing
adenotonsillectomy: a randomised, single -blind, parallel group trial. Pediatr Anesth.
http:/doi.wiley.com/10.111/pan.13517
*² IRi Total Pharmacy, MAT to 6 June 2021.

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 Maxigesic® Oral Liquid
Maxigesic Oral Liquid [paracetamol 160mg + ibuprofen 48mg per 5mL] is a unique
combination of paracetamol and ibuprofen in the same patented synergistic 3.3:1
ratio as other Maxigesic dose forms. It is not yet approved in Australia or New Zealand.
About Maxigesic® Cold & Flu Hot Drink
Maxigesic Cold & Flu Hot Drink powder for oral liquid hot drink is a unique combination
of paracetamol and ibuprofen in the same patented synergistic 3.3:1 ratio as other
Maxigesic dose forms. It has two strengths being Paracetamol 1000mg + Ibuprofen
300mg and Paracetamol 500mg + Ibuprofen 300mg per sachet. It is approved in
Australia but not New Zealand to date.
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

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

Zealand and in certain Asian markets, and to out-license 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
.