GENERAL: AFT: Maxigesic® IV licensed in eight new European marketsOpens in a new Window

5 March 2021

Maxigesic® IV licensed in eight new European markets

AFT Pharmaceuticals (NZX.AFT, ASX.AFP) today announces it has signed an exclusive Maxigesic® IV licensing agreement for eight new European markets.

The agreement, which due to COVID-19 restrictions was negotiated and sealed entirely online, is with the Lyon, France-based Aguettant. It means Maxigesic IV will now be available in 20 of the 27 EU member states, including Germany, France, Italy and Spain as well as the UK.

Maxigesic IV (Paracetamol 1000mg + Ibuprofen 300mg solution for infusion) is a patented intravenous formulation developed as a line extension to Maxigesic tablets, for use post-operatively in hospitals when patients cannot take a medicine orally.

In addition to Spain, Aguettant gains the rights to the medicine in the five Nordic markets (Finland, Norway, Denmark, Sweden, Iceland), Portugal, and the Netherlands. AFT expect sales of the medicine in these territories to commence in early 2022.

AFT Pharmaceuticals Managing Director Dr Hartley Atkinson said: "We are delighted to have reached this agreement with Aguettant, which specialises in injectable pharmaceuticals and has a strong sales record in the hospital sector across the EU.

"The agreement extends Maxigesic IV's footprint across Europe and significantly expands the market for the medicine. In Spain, for instance, more than 2.5 million surgeries are performed annually1, while a further 1.1 million surgical procedures are completed in the Nordic countries2. Maxigesic IV offers a non-opiate therapeutic alternative for many of these cases.

"The potential for Maxigesic IV and other dose forms of the medicine is significant. The market for post-operative pain, which is a subset of Maxigesic's total addressable market, is growing rapidly and is forecast by independent market research to reach US$553 million in 2028 across the 5 major markets of Europe (up from US$178 million in 2019)3.

"Particularly, this research has suggested that our Maxigesic IV platform in the same geographies and market has the potential to grow to generate annual in- market sales of more than US$88 million4. We are looking forward to working with Aguettant to help us realise its potential," Dr Atkinson said.

Dr Atkinson also thanked the teams from both companies for their commitment to the deal in the face of the commercial challenges of the COVID-19 pandemic.

"The agreement is a testament to the adaptability and resilience of both Aguettant and AFT. Despite the difference in time zones and the challenges of the current travel bans we have put together an agreement that will improve health outcomes in Europe and drive increases in shareholder value."

Eric Rougemond, CEO of Aguettant states about the new agreement: "We are delighted to begin our partnership with AFT. Adding Maxigesic IV formulation to our portfolio of injectable medicines means we can propose to healthcare professionals and their patients a brand-new pain management solution for acute moderate pain. It is fully in line with our objectives to support safer medical practices, make the everyday work of practitioners easier and improve the quality of life of patients. We are very much looking forward to starting our commercialization in Spain, Portugal, The Netherlands and the Nordic countries."

A major Phase 3 clinical trial conducted in the USA found that Maxigesic IV provided significantly better pain relief than either paracetamol (acetaminophen) IV or ibuprofen IV alone in the same doses5. Further recently completed exposure trials have demonstrated the drug's efficacy and safety in an expanded population group over a longer treatment period6.

Following on from the registration of Maxigesic IV in Australia and New Zealand in mid-2019, AFT has now licensed the medication in more than 90 countries. Meanwhile, the tablet form of Maxigesic has been licensed in more than 125 countries.

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

For more information:

Investors	Media
Dr Hartley Atkinson	Richard Inder
Managing Director	The Project
AFT Pharmaceuticals	Tel: [phone]
Tel: [phone]

1,3,4 DelveInsight Report (2020). Postoperative Pain Market Insights, Epidemiology and Market Forecast-2028. DelveInsight.

2. Calculated using surgery data from Health Statistics for the Nordic Countries. Nordic Medico-Statistical Committee 100:2013 and World Bank Population Data

5. Daniels, S.E, Playne, R., Stanescu, I., Zhang, J., Gottlieb, I.J, Atkinson, H.C. (2019). Efficacy and safety of an intravenous acetaminophen/ibuprofen fixed-dose combination after bunionectomy: A randomized, double-blind, factorial, placebo- controlled trial. Clinical Therapeutics 41 (10): 1982-1995. Research sponsored by AFT Pharmaceuticals.

6. Maxigesic® IV Phase 3 Exposure Study. Study ID No. AFT-MXIV-11. NCT04005755. Extending the safety profile of the post-operative administration of an intravenous acetaminophen/ ibuprofen fixed dose combination: an open-label, multi-center, single arm, multiple dose study. Submitted for publication

About AFT Pharmaceuticals

AFT is a growing multinational pharmaceutical business with a broad range of products, both developed itself and in-licensed from third parties. AFT's products cover all major pharmaceutical distribution channels: over the counter, prescription, and hospital. Historically, AFT's home markets have been Australia, New Zealand, and South-East Asia. However, the company is out-licensing its own products to licensees and distributors to sell in an increasing number of countries around the world. The company's intensive Research and Development program forms the basis of its international sales strategy. For more information about the company, visit our websitewww.aftpharm.com

About Aguettant

Aguettant is a family-owned pharmaceutical company dedicated to the development, industrial production and distribution of innovative injectable pharmaceutical specialties that meet the demands and the needs of healthcare professionals and patients. Founded in Lyon, France in 1903, Laboratoire Aguettant's growth has been rooted in its engagement with the medical world and its pharmaceutical expertise in injectable medication. For more information about the company, visit our website:www.aguettant-corporate.com

About Ferghana Partners (New York, London, Boston) initiated the Aguettant transaction and provided strategic/financial advisory services to AFT Pharma.