Mundipharma and Vectura announce plans to reformulate flutiform® (fluticasone propionate/formoterol fumarate) pressurised metereddose inhaler (pMDI) as a commitment to reducing the product’s carbon footprint

Mundipharma and Vectura announce plans to reformulate flutiform® (fluticasone propionate/formoterol fumarate) pressurised metereddose inhaler (pMDI) as a commitment to reducing the product’s carbon footprint For Medical and Trade media only • The two companies have entered into a collaboration agreement to continue the development work of incorporating an environmentally friendly propellant into the formulation of flutiform® (fluticasone propionate/formoterol fumarate) used in a pressurised metered-dose inhaler (pMDI). • The aim is to achieve a near-zero-emissions product with a significantly lower impact on global warming, which aligns with European Union regulation on fluorinated greenhouse gases.1 • Steps have already been taken to reduce the level of propellant; thus, the product currently has a reduced carbon footprint compared to when it was originally launched.2 Cambridge, UK, 16 April 2024 – Mundipharma and Vectura will now progress development of the reformulation of flutiform® (fluticasone propionate/formoterol fumarate) following long-term collaboration, planning and lab-scale development work. The reformulation will ultimately ensure a comparable effective product for patients and further reduce its impact on the environment. The product is an established pressurised metered-dose inhaler (pMDI) for the treatment of asthma, where the use of a combination product is appropriate, and has been available on the market for more than a decade. 3 It currently uses the approved apaflurane hydrofluoroalkane 227 (HFA-227), a type of fluorinated greenhouse gas, as its propellant. 3 European Union regulation on these types of gases aims to reduce their use, and therefore their emissions, by two-thirds by 2030.1 Work is already under way to source an alternative to the HFA-227 gas used in fluticasone propionate/formoterol fumarate pMDI. This new collaboration will revitalise the efforts to identify and switch to a more environmentally friendly propellant. If successful, this will result in a significantly lower impact on global warming and alignment with European Union regulation on fluorinated greenhouse gases.1 With more than 262 million people living with asthma globally, the reformulation of some asthma treatments to reduce carbon emissions could have a significant impact on the global carbon footprint. 4,5 “We are dedicated to positively influencing the life of asthma patients across the globe. This is the first step in our long-term plan to develop a near-zero-emissions asthma inhaler. We are determined to achieve this before the European Union ban of HFA (hydrofluoroalkane) gases comes into effect, and our collaboration with Vectura demonstrates this, as well as our aim to an overall commitment to sustainable healthcare innovation,” said Yuri Martina, Chief Development and Medical Officer at Mundipharma. “At Vectura, our priority is to ensure that patients prescribed fluticasone propionate/formoterol fumarate pMDI can continue to have access to this treatment. Using Vectura’s expertise and extensive track record in the development of inhaled prescription medicines and devices, we believe the collaboration with Mundipharma will enable us to meet our environmental responsibilities and enable patients to use fluticasone propionate/formoterol fumarate pMDI in the years to come,” said Geraldine Venthoye, Chief Scientific Officer, Vectura. ®: FLUTIFORM is a registered trademark of Jagotec AG used under licence by Mundipharma. References 1. Regulation (EU) No 517/2014 of the European Parliament and of the Council of 16 April 2014 on fluorinated greenhouse gases and repealing Regulation (EC) No 842/2006 Text with EEA relevance. Available at: https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=uriserv:OJ.L_.2014.150.01.0195.01.ENG (last accessed March 2024) 2. flutiform® pMDI emissions manufacturing data, Q4 2022 – Q4 2023. Data on file. 3. flutiform® Summary of Product Characteristics (SmPC). Last updated 13 April 2022. https://www.emcpi.com/pi/26954. (last accessed April 2024). 4. Global burden of 369 diseases and injuries in 204 countries and territories, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020;396(10258):1204-22 5. NHS England, World Asthma Day: tackling climate change and improving respiratory care. Available at https://www.england.nhs.uk/blog/world-asthma-day-tackling-climate-change-and-improving-respiratory-care/ (last accessed March 2024) *ENDS* Job code: SciA-FLU-2400001| Date of preparation: April 2024 ____________________________________________________________________________ Notes to Editors About flutiform® (fluticasone propionate/formoterol fumarate): flutiform® is an inhaler (a pressurised metered-dose inhalation, suspension) which contains two active ingredients, fluticasone propionate and formoterol fumarate dihydrate.3 This fixed-dose combination of fluticasone propionate and formoterol fumarate (flutiform®) is indicated in the regular treatment of asthma where the use of a combination product (an inhaled corticosteroid and a long-acting β₂ agonist) is appropriate for the management of asthma symptoms. 3 About Mundipharma: Mundipharma is a global healthcare company with a presence across Africa, Asia Pacific, Canada, Europe, Latin America and the Middle East. Mundipharma is dedicated to bringing innovative treatments to patients in the areas of respiratory, pain management, infectious disease as well as other severe and debilitating disease areas. Our guiding principles, centred around Integrity and Patient-Centricity, are at the heart of everything we do. For more information visit www.mundipharma.com. About Vectura: Vectura is a specialist inhalation contract development and manufacturing organization (CDMO) that provides inhaled drug development solutions to help customers bring their medicines to patients. With 25 years’ experience, it provides a combination of formulation science, device technology, and inhaled development expertise. Vectura is a member of the Vectura Fertin Pharma group of companies. For more information visit www.vectura.com For further information please contact: Liana Del Medico Global VP Communications & Corporate Affairs, Mundipharma E: media.relations@mundiphar ma.com Lesley Ferguson White Chief Communications Officer, Vectura Fertin Pharma E: lesley.fergusonwhite@vecturafertinpharma. com Gurjit Chahal Senior Director, Public Relations, Makara Health, a Precision Value & Health Company M: +44 (0) 7917 796 836 E: gurjit.chahal@precisionvh.co m