Maxigesic IV registration in Australia

Market and Media release 24
th
July 2019


AFT Pharmaceuticals’ achieves first registration of it’s patented
painkiller Maxigesic IV
®
in the pivotal Australian market

AFT Pharmaceuticals (‘AFT’) today announces it has successfully registered the
intravenous form of its successful ‘Maxigesic’ pain relief medication with
Australia’s Therapeutic Goods Administration (TGA).

Maxigesic IV
®
(paracetamol 1000 mg and ibuprofen (as sodium dihydrate) 300
mg) in 100 mL solution for infusion vial has now been placed upon the
Australian Register of Therapeutic Goods (ARTG), giving AFT approval to sell
this line extension of Maxigesic in Australia.

Sales of Maxigesic IV
®
are now expected to take place in the current financial
year (FY2020). Meanwhile, the (ARTG) registration clears the way for regulatory
filings in a number of other territories including but not limited to Mexico, South
East Asia, Korea and the Middle East, all of which rely upon registration by key
global reference regulators such as the TGA in Australia.

Maxigesic IV has been developed as a line extension to Maxigesic tablets, for
post-operative pain relief in hospitals where patients cannot take an oral pain
relief medicine such as Maxigesic.

A major Phase 3 clinical trial conducted in 276 patients in Texas and Maryland
USA found that Maxigesic IV provided significantly better pain relief than either
paracetamol (acetaminophen) IV or ibuprofen IV alone in the same doses.*

AFT Managing Director, Dr Hartley Atkinson, says he is very pleased to further
extend the company’s offering of the Maxigesic portfolio.

“With a population of over 25 million** and being the largest home market for
AFT, we believe that Australia represents great potential for Maxigesic IV.
Meanwhile, registration with the TGA is an important first step towards the
commercialisation of the medication in other markets,” said Dr Atkinson.

Investors Media
Dr Hartley Atkinson, Richard Inder
CEO, AFT Pharmaceuticals Ltd The Project
Phone: +64 9 488 0232 Phone: +64 21 645 643
Email: hartley@aftpharm.com Email: richard@theproject.co.nz

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 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:
www.aftpharm.com


Reference
* Daniels SE et al. Efficacy and safety of an IV acetaminophen/ibuprofen
combination after bunionectomy. A randomized, double-blind, factorial,
placebo-controlled trial. Clinical Therapeutics, in press.
** Source: https://www.worldometers.info/world-population/australia-
population/