Acetaminophen/Ibuprofen

An independent survey of New Zealand pharmacists has revealed that many pharmacists have significant concerns about over-the-counter (OTC) codeine-based analgesics. Company founder and Managing Director, Dr Hartley Atkinson, says that AFT Pharmaceuticals wanted to know the extent to which New Zealand pharmacists are concerned about the risks associated with codeine-based analgesics, and their openness to alternative non-codeine products. “The views of pharmacists here are really important,” said Dr Atkinson. “They know this category of product intimately, and they are the experts that people rely on for advice around OTC pain relief options. If they have concerns around codeine-based products, then our industry needs to know about it”. AFT Pharmaceuticals contracted Dart Public Affairs in Wellington to undertake the survey. No mention was made in the survey of AFT Pharmaceuticals or its codeine-free analgesic Maxigesic®. The survey had 493 responses. The results of the survey showed that: • 70% of respondents said they were either somewhat concerned, or very concerned, about the potential for adverse consequences resulting from the ordinary use of codeine-based analgesics. • 98% said they were either somewhat concerned, or very concerned, about the potential for adverse consequences resulting from the misuse of codeine-based analgesics. • 74% either somewhat agreed, or strongly agreed, when asked whether they thought codeine combinations are used too often by consumers and patients in New Zealand. “These results indicate that a number of pharmacists have real concerns about the use of codeine- based analgesics,” said Dr Atkinson. “Nearly all respondents have concerns with the potential for abuse of these products. Plus over two-thirds are concerned about dependence risks resulting from ordinary usage – in other words, people using the product as directed.” The results mirror concerns being expressed in media reports both here and overseas as to the increasing prevalence of codeine dependence resulting from OTC codeine-based analgesics. Questions are also being asked of the value codeine adds to analgesics. Jennifer Pilgrim and Olaf Drummer of Monash University recently concluded that there is little evidence that combining low- dose codeine with simple analgesics provides more than a trivial benefit for pain relief.[1] Ross Tsutuki, editor of the Canadian Pharmacists Journal and a professor of medicine at the University of Alberta, has suggested that the addition of codeine to analgesics brings very little in the way of medicinal benefits, but brings with it quite significant risks.[2] Dr. Atkinson says the results of this survey give AFT Pharmaceuticals a lot of comfort. “It was clear to us quite a few years ago that codeine would become a serious issue. So we built Maxigesic® from the ground up to create an effective OTC painkiller that doesn’t use codeine. We’re now in the fortunate position of having a trusted and effective non-codeine analgesic at the same time as the safety and efficacy of codeine is increasingly under the spotlight”. According to Dr Atkinson, one of the most interesting results from the survey was the willingness of pharmacists to be open to newer OTC analgesics that do not rely on codeine-based ingredients. When pharmacists were asked in the survey whether paracetamol-ibuprofen combination products could be a suitable alternative to codeine-based combinations, 72% of respondents either agreed or strongly agreed. “This shows that pharmacists are quite open to products that take a different approach from how things have been done in the past. Frankly that’s very encouraging for us as a company given that our emphasis has always been on innovation and thinking outside the box.” 1 Jennifer Pilgrim and Olaf Drummer “In reply: Fatal misuse of codeine–ibuprofen analgesics in Victoria, Australia” Medical Journal of Australia 2014; 200(3): 150151. 2 Jennifer Yang and Diana Zlomislic “Canada’s invisible codeine problem” Toronto Star (17 January 2015).

AFT Pharmaceuticals (NZX; AFT, ASX; AFP) notes the publication of new market research that estimates the potential for AFT’s patented medicine Maxigesic in managing postoperative pain in the US, Japan and the top 5 European Union countries [France, Germany, Italy, Spain and UK]. The independent research, entitled ‘Postoperative Pain Market Insights, Epidemiology and Market Forecast—2028′1, estimates the Maxigesic platform has the potential to generate sales of US$441.9 million in these markets by 2028. The research, by life science consulting and market research firm Delveinsight https://www.delveinsight.com), also estimates the market for postoperative pain relief will grow at a compound annual growth rate of 10.26% from US$1.1 billion in 2019 to reach US$2.6 billion in 2028. AFT Pharmaceuticals Managing Director Hartley Atkinson said Delveinsight’s forecasts for Maxigesic were prepared independently of AFT and that AFT was unaware that the research was being undertaken, and the company expresses no view on the accuracy of the research nor its conclusions. “We note that the conclusions of the report are subject to a number of assumptions including one that AFT will obtain regulatory approval of the intravenous formulation, Maxigesic IV, in 2021 in the two largest markets identified in the study, the US and Japan. However, it is positive that the market is seen to more than double over this time period with the anticipated increase in new non-opioid analgesic medications for treatment of post-operative pain. “AFT is seeking regulatory approvals for Maxigesic in Europe, Japan and the US. However, there can be no certainty of achieving these goals within the timeframe specified in the DelveInsight report. “Moreover, even if the company does obtain the necessary regulatory approvals within the specified timeframe, there is no certainty that licensees in these markets will make the sales estimated in the report, AFT has to date licensed Maxigesic IV in over 70 countries including recently Canada, Indonesia and Pakistan. However, it is positive that an independent party sees the market category as growing and that Maxigesic is well placed to compete with new products in the category” Dr Atkinson said. AFT has already received regulatory approval for the tablet form of the Maxigesic medication in 44 countries including all members of the European Union and the UK. It has also obtained regulatory approval for the intravenous form of Maxigesic in Australia and New Zealand to date with a significant number of new registrations presently underway and to be filed during this calendar year. “AFT will be making no further comment on the DelveInsight report,” Dr Atkinson said. For and on behalf of AFT Pharmaceuticals Limited, Malcolm Tubby, CFO Notes to editors: Maxigesic IV is a patented, fixed ratio of ibuprofen (as sodium dihydrate 300 mg) for anti-inflammation management and paracetamol (1000 mg) for pain management. Its tablet form is licensed in more than 125 jurisdictions worldwide, registered in 44 jurisdictions and sold in 24 under a variety of different brands2. AFT is also licensing and seeking regulatory approval for other dose forms of the medication including Maxigesic IV. 1Postoperative Pain Market Insights, Epidemiology and Market Forecast—2028. Delveinsight. 2 As at 30 September 2019. For more information: Investors Dr Hartley Atkinson Managing Director AFT Pharmaceuticals Tel: +64 9488 0232 Media Richard Inder The Project Tel: +64 21 645 643 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 over 125 countries around the world. For more information about the company, visit our website www.aftpharm.com.