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AFT adds COMBOGESIC Tablets to Hikma Agreement in US

8/08/2024, 08:53 NZST, GENERAL

08 August 2024 AFT adds COMBOGESIC® (acetaminophen and ibuprofen) Tablets to Hikma Agreement in US. AFT Pharmaceuticals (NZX: AFT, ASX: AFP) today announces an Agreement with Hikma Pharmaceuticals USA (“Hikma”) to distribute its patented1 COMBOGESIC® Tablets, a fixed dose combination (FDC) (acetaminophen and ibuprofen), non-opioid analgesia in a single tablet for adult pain management to select markets in the United States, the largest pharma market in the world.2 The Agreement furthers the cooperation between the companies after the 21 April 2021 agreement between AFT and Hikma for the intravenous form, COMBOGESIC® IV, and will cover market segments where the IV dose form will be used such as hospitals and ambulatory surgical centres. AFT Managing Director Dr Hartley Atkinson said: “COMBOGESIC® IV was launched by Hikma in February this year and we believe that the addition of the oral dose form, COMBOGESIC® Tablets will assist uptake of the IV dose form in addition to sales of the tablet. As previously indicated, we are planning to see tablet sales start during this calendar year. AFT will benefit from the agreement by means of a profit share. Hikma is a global pharmaceutical company focused on complex and differentiated generic and branded generic pharmaceuticals across a broad range of indications, including respiratory, oncology and pain management. It is the third largest US supplier of generic injectable medicines by volume3, and a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty, and branded pharmaceutical products that hospitals, physicians, and pharmacists need to treat their patients. - ENDS – This product has been approved for marketing in the United States by the U.S. FDA. This product approval does not confer the right on Hikma, or any other party, to market this product outside the United States. 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 About COMBOGESIC® IV COMBOGESIC® IV is the only IV analgesic therapy formulated with 1,000 mg of acetaminophen and 300 mg of ibuprofen, utilizing the synergistic effect of both medicines for optimal pain relief.4 It offers health care providers an advanced approach to multimodal analgesia by combining active drug substances with different mechanisms of action that harness additive or synergistic effects to provide more effective pain relief compared with individual components used as single-modality interventions.4-6 COMBOGESIC® IV is supplied as a readily available solution with no mixing required for administration.4 It is administered as a 15-minute IV infusion, every 6 hours as needed, not to exceed the maximum total daily dose of 4,000 mg acetaminophen and 1,200 mg of ibuprofen in 24 hours.4 About AFT Pharmaceuticals AFT is a growing New Zealand based 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 in our markets of Australia, New Zealand, Singapore, Malaysia, Hong Kong, USA, Canada, EU ex Ireland and UK, 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. About Hikma (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated BBB-/stable S&P and BBB-/positive Fitch) Hikma helps put better health within reach every day® for millions of people around the world. For more than 45 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across the North America, the Middle East and North Africa (MENA) and Europe, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. We're committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines. Together, our 9,100 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner, and through our venture capital arm, are helping bring innovative health technologies to people around the world. For more information, please visit: www.hikma.com. Footnotes 1. Multiple patents. FDA Orange book - COMBOGESIC N 209471 001 10532036 Sep 22, 2025 11197830 Feb 27, 2039 11534407 Feb 27, 2039 U-3553 2.https://www.statista.com/statistics/245473/market-share-of-the-leading-10-global-pharmaceutical-markets/ 3. IQVIA MAT May 2024, generic injectable volumes by eaches, excluding branded generics and Becton Dickinson 4. COMBOGESIC® IV (acetaminophen 1000 mg and ibuprofen 300 mg) [package insert]. 5. Daniels SE, Playne R, Stanescu I, et al. Efficacy and safety of an intravenous acetaminophen/ibuprofen fixed-dose combination after bunionectomy: a randomized, double-blind, factorial, placebo-controlled trial. Clinical Therapeutics. 2019;41(10). 6. Chou R, Gordon DB, de Leon-Casasola OA, et al. Management of post operative pain: a clinical practice guideline from the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016;17:131-157. COMBOGESIC® is a registered trademark of AFT Pharmaceuticals Limited. In ANZ, Middle East and Asia the trademark, Maxigesic® is used.