Press Releases

Key Highlights Regulatory submissions for next-generation propellant pMDIs (pressurised metered-dose inhalers) Fostair^® (beclometasone / formoterol) and Trimbow^® (beclometasone / formoterol / glycopyrronium) have been validated by Regulatory Agencies in Europe and assessments are now underway.^1-4 Chiesi’s transition to HFA-152a*, a next-generation propellant classified as non-PFAS† and with low global warming potential (GWP), aims to reduce the carbon footprint of its pMDIs by up to 90%.^5-7 The transition supports Chiesi’s ambition to reach Net Zero‡ across its full value chain by 2035.⁸ Manchester, UK – 3rd September 2026 – Chiesi Group, an international research-focused biopharmaceutical company and certified B Corp, today announces the progression of its Carbon Minimal Inhaler (CMI) portfolio with the validation of European regulatory submissions for the transition of Fostair® (beclometasone / formoterol) and Trimbow® (beclometasone / formoterol / glycopyrronium) to a next-generation, low-GWP propellant.^1-4 The validation of regulatory submissions for these products means the assessment processes have officially begun and marks a significant step towards Chiesi’s transition to carbon minimal pMDIs. The transition supports the company’s broader ambition to reduce the environmental impact of respiratory care while ensuring that patients maintain access to the device that is most suitable for them. “At Chiesi, our focus is on delivering innovation that supports both patients and the planet - reducing environmental impact, while preserving choice and flexibility in treatment. By evolving our portfolio in this way, we’re changing so patients don’t have to.” said Ralph Blom, General Manager, Chiesi UK and Ireland. Many of Chiesi’s pMDIs are transitioning to HFA-152a*, a next-generation propellant classified as non-PFAS† and with low-GWP, designed to reduce the products’ carbon footprint by up to 90%, compared with its current pMDIs which are formulated with HFA-134a*.^5-7 Pharmacokinetic and safety studies have demonstrated therapeutic equivalence and tolerability between the propellants, within Chiesi’s pMDI portfolio.^9-13 Chiesi’s transition is focused on reducing the carbon footprint associated with pMDIs, a device which remains an important option in respiratory care. Transitioning its pMDIs to the next-generation propellant, HFA-152a*, supports the decarbonisation of respiratory care while helping to safeguard access and continuity of care over the long term.^{5, 14-16} Beclometasone / formoterol / glycopyrronium has been submitted under the EU centralised procedure to the European Medicines Agency, while beclometasone / formoterol is being managed through a coordinated multi-country regulatory procedure with BfArM – the German Federal Institute for Drugs and Medical Devices – acting as Reference Member State. The UK regulator - the Medicines and Healthcare products Regulatory Agency (MHRA) - will validate these procedures once complete, with UK regulatory approval anticipated in the first half of 2027. *HFA: hydrofluoroalkane. †PFAS: per- and polyfluoroalkyl substances. ‡Net Zero Commitment Chiesi plans to be the first pharmaceutical company to achieve Net Zero greenhouse gas emissions across its entire value chain by 2035, 15 years ahead of the European Climate Neutrality target. This commitment covers all emission scopes. Chiesi’s targets were validated by the Science Based Targets initiative (SBTi) in April 2024.⁸ The Group has consolidated its greenhouse gas inventory in line with ISO 14064 and the Greenhouse Gas (GHG) Protocol standards, with annual audits carried out by independent third parties. The transition to the next-generation propellant is one of the most impactful actions in Chiesi’s Net Zero roadmap, as inhaler propellants represent the single largest source of the Group’s greenhouse gas emissions. About Chiesi Group Chiesi is a research-oriented international biopharmaceutical group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care. The company’s mission is to improve people’s quality of life and act responsibly towards both the community and the environment. By adopting the legal form of Benefit Corporation in Italy, the US, France, and Colombia, Chiesi’s commitment to creating shared value for society as a whole is legally binding and central to company-wide decision-making. As a certified B Corp since 2019, Chiesi is part of a global community of businesses that meet verified standards for social and environmental business practices. The company aims to reach Net Zero greenhouse gases (GHG) emissions by 2035. With 90 years of experience, Chiesi is headquartered in Parma (Italy), with 31 affiliates worldwide, and counts more than 7,500 employees. The Group’s research and development center in Parma works alongside 6 other important R&D hubs in France, the US, Canada, China, the UK, and Sweden. For further information, please visit www.chiesi.uk.com ****** Press info: Yasmin Ghariani Head of Communications, UK and Ireland Phone: (+44) 161 488 5555 Email: y.ghariani@chiesi.com References Electronic Medicines Compendium. Fostair pMDI 100/6, Summary of Product Characteristics. Electronic Medicines Compendium. Fostair pMDI 200/6, Summary of Product Characteristics. Electronic Medicines Compendium. Trimbow pMDI 87 micrograms/5 micrograms/9 micrograms, Summary of Product Characteristics. Electronic Medicines Compendium. Trimbow pMDI 172 micrograms/5 micrograms/9 micrograms, Summary of Product Characteristics. Panigone S et al 2020, BMJ Open Respiratory Research: Environmental impact of inhalers for respiratory diseases: decreasing the carbon footprint while preserving patient-tailored treatment. Available at: https://doi.org/10.1136/bmjresp-2020-000571. EU ECHA Webinar: Restriction of per- and polyfluoroalkyl substances (PFAS) under REACH. OECD. Reconciling Terminology of the Universe of Per- and Polyfluoroalkyl Substances 2021. Available at: https://www.oecd.org/en/publications/reconciling-terminology-of-the-universe-of-per-and-polyfluoroalkyl-substances_e458e796-en.html. Chiesi UK. Sustainability Report 2024. Available at: https://www.chiesi.uk.com/sustainability/reports. Rony F et al 2024, Pulmonary Pharmacology & Therapeutics: Evaluating the pharmacokinetics of beclometasone dipropionate/formoterol fumarate/glycopyrronium bromide delivered via pressurized metered-dose inhaler using a low global warming potential propellant. Available at: https://doi.org/10.1016/j.pupt.2024.102299. Almeida M et al 2026, Switching to a Low Global Warming Potential Propellant in a Pressurized Metered-Dose Inhaler Does Not Affect the Pharmacokinetics of Combined Beclometasone Dipropionate/Formoterol Fumarate. Available at: https://www.sciencedirect.com/science/article/abs/pii/S0149291826001128. Salvadori M et al 2025, Pulmonary Pharmacology & Therapeutics: The low global warming potential propellant HFA-152a does not induce bronchoconstriction or impair mucociliary clearance. Available at: https://doi.org/10.1016/j.pupt.2025.102358. Singh D et al 2026, Respiratory Medicine: Safety and tolerability of the low global warming potential propellant HFA-152a in patients with asthma receiving beclometasone dipropionate/formoterol fumarate/glycopyrronium: The TRECOS study. Available at: https://doi.org/10.1016/j.rmed.2026.108814. Rony F, Pittelli MG, Contursi C, Pacchetti I, Calabrò ER, Viganò LV, et al 2025, Pulmonary pharmacology & therapeutics: Impact on beclometasone dipropionate pharmacokinetics when switching to a low global warming potential propellant in a pressurised metered-dose inhaler. Available at: https://pubmed.ncbi.nlm.nih.gov/40090514/. Pernigotti D et al 2021, BMJ Open Respiratory Research: Reducing carbon footprint of inhalers: analysis of climate and clinical implications of different scenarios in five European countries. Available at: https://doi.org/10.1136/bmjresp-2021-001071. Attar-Zadeh D et al 2021, Journal of Health Economics and Outcomes Research: Health-care Resource Requirements and Potential Financial Consequences of an Environmentally Driven Switch in Respiratory Inhaler Use in England. Available at: https://doi.org/10.36469/001c.26113. Usmani O et al 2022, Journal of Allergy Clinical Immunology Practice: Real-World Impact of Nonclinical Inhaler Regimen Switches on Asthma or COPD: A Systematic Review. Available at: https://doi.org/10.1016/j.jaip.2022.05.039. UK-CHI-2600363 | September 2026

 NHS England has recommended mercaptamine bitartrate (cysteamine) gastro-resistant hard capsules, also referred to as “delayed-release mercaptamine bitartrate” for routine commissioning for eligible patients aged one year and above with nephropathic cystinosis.¹ Nephropathic cystinosis affects around 1 in 100,000 to 200,000 live births, with approximately 200 people living with the condition in the UK and two to three new cases diagnosed each year.^{1, 2} The treatment provides an additional cystine-depleting therapy option that can be taken twice-daily, compared to four-times-daily dosing every six hours for the currently commissioned immediate-release formulation.¹  Manchester, UK – 5th August 2026 – Chiesi UK and Ireland welcome NHS England’s decision to recommend delayed-release mercaptamine bitartrate (a cystine-depleting agent) for routine commissioning for eligible patients living with nephropathic cystinosis. The decision means eligible patients aged one year and above who meet the defined clinical criteria* can access an additional treatment option through NHS England specialised services, expanding choice for people living with this ultra-rare condition. Care for people with nephropathic cystinosis is often complex, time-consuming and demanding for both patients and their families.^2,3 With treatment options previously limited, requiring multiple daily doses, this treatment option with a twice-daily dosing schedule, can potentially help reduce disruption to daily routines for patients and carers, improve adherence, delay complications and improve patients’ quality of life.¹ "We welcome NHS England's decision to routinely commission delayed-release mercaptamine bitartrate for eligible people with nephropathic cystinosis," said David Game, Consultant Nephrologist and Clinical Lead for the Delayed-Release Mercaptamine Policy Proposal. "Nephropathic cystinosis is a lifelong condition, and this decision marks an important milestone for the cystinosis community in England. By providing eligible patients and their clinicians with access to an additional treatment option, it supports treatment decisions based on individual patient needs and reflects the collaborative efforts of clinicians, patients, families and patient organisations throughout the policy process." Nephropathic cystinosis is an ultra-rare, progressive condition affecting around 200 people in the UK.¹ The disease is caused by the accumulation of cystine, an amino acid, within cells throughout the body.¹ This can lead to tissue and organ damage, particularly in the eyes and kidneys.^1,4 Around 150 patients are estimated to be eligible for delayed-release mercaptamine bitartrate under NHS England's new commissioning policy.¹ David Garzón, Senior Director, Rare Diseases at Chiesi UK and Ireland, added: “This is an important milestone for the nephropathic cystinosis community in England, providing an additional treatment option for these patients with a twice-daily dosing regimen, that can help alleviate some of the treatment burden for patients and their families. Following earlier reimbursement decisions in Northern Ireland, Wales and Scotland, this decision marks an important step towards more equitable access across the UK, reflecting the collaborative efforts of clinicians, patient organisations, patients and families.”  Delayed-release mercaptamine bitartrate is approved across the UK and Europe, including in France, Italy, Germany and Ireland. Following NHS England's decision to routinely commission the treatment for eligible patients 1 year and above with nephropathic cystinosis, the medicine is now routinely available across all UK nations for patients meeting local access criteria. Comments from the Patient Community  Will Newman, Chairperson of Cystinosis Foundation UK, said: “We are delighted to see this decision, which represents an important step forward for the nephropathic cystinosis community in England. The approval means patients and carers can now explore whether this formulation better suits their individual circumstances, lifestyles, and tolerability needs.”   Laura Smith Van Carroll, Head of Insight & Advocacy at Metabolic Support UK, said: “We are delighted that people living with cystinosis in England will now have access to Procysbi, bringing equitable treatment choice across the UK after many years of availability in Wales, followed by Scotland and more recently Northern Ireland. For many families, this approval has the potential to reduce the burden of frequent dosing, allowing uninterrupted sleep, and giving people greater choice in how they manage this lifelong condition. While we welcome this decision, we hope future CPAG processes will provide clearer timelines and secure funding alongside approval, helping people with rare conditions access new treatments more quickly and with greater certainty.”   About Procysbi® (delayed-release mercaptamine bitartrate) Procysbi (delayed-release mercaptamine bitartrate) is a beaded, enteric-coated, delayed-release form of cysteamine, in which the microspheronised beads are further encapsulated in hard gelatin to allow oral administration every 12 hours.⁴ The treatment is administered twice-daily.  Delayed-release mercaptamine bitartrate is available in either 25 mg or 75 mg gastro-resistant hard capsules of cysteamine.⁵ Therapy should be initiated as early as possible following diagnosis and continued throughout life.  About Chiesi Group     Chiesi is a research-oriented international biopharmaceutical group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care. The company’s mission is to improve people’s quality of life and act responsibly towards both the community and the environment.  By changing its legal status to a Benefit Corporation in Italy, the US, France and Colombia, Chiesi’s commitment to creating shared value for society as a whole is legally binding and central to company-wide decision-making. As a certified B Corp since 2019, Chiesi is part of a global community of businesses that meet verified standards for social and environmental business practices. The company aims to reach Net-Zero greenhouse gases (GHG) emissions by 2035. With 90 years of experience, Chiesi is headquartered in Parma (Italy), with 31 affiliates worldwide, and counts more than 7,900 employees. The Group’s research and development centre in Parma works alongside six other important R&D hubs in France, the US, Canada, China, the UK, and Sweden.  For further information please visit www.chiesi.uk.com Media contacts:  Yasmin Ghariani, Chiesi UK and Ireland Head of External Communications Phone: (+44) 161 488 5555 Email: y.ghariani@chiesi.com   UK-PCB-2600003 | July 2026   References   * Inclusion criteria can be found in the guidance here: Report template - NHSI website.     NHS England. Clinical Commissioning Policy: Delayed-release mercaptamine bitartrate for patients with nephropathic cystinosis (Age > 1 years) [URN 2338]. Available at: Report template - NHSI website. Cystinosis Foundation UK. What is Cystinosis? Available at: What Is Cystinosis? – Cystinosis Foundation UK. Available at: https://www.cystinosis.org.uk/learn-more/what-is-cystinosis/ [Last accessed July 2026] Golestaneh L, Ames EG, Doyle MH, et al. Improving Lifelong Comprehensive Care Coordination in Nephropathic Cystinosis: Multidisciplinary Perspectives. Kidney Int Rep. 2026;11(3):103735. doi:10.1016/j.ekir.2025.103735. PROCYSBI 75 mg gastro-resistant hard capsules - Summary of Product Characteristics (SmPC) - (emc). Medicines.org.uk. 2025. Available at: https://www.medicines.org.uk/emc/product/2080/smpc   All Wales Medicines Strategy Group, Final Appraisal Recommendation Advice number: 0922, April 2022. Ariceta G, Giordano V, Santos F. Effects of long-term cysteamine treatment in patients with cystinosis. Pediatr Nephrol. 2019 Apr;34(4):571-578.

Between 2024 and 2025, there were over two hundred and fifty kidney transplants performed in Manchester.¹ Around 30-40% of kidney transplants do not last beyond 10 years, meaning many patients require further treatment or another transplant.² Outcomes after kidney transplantation are not experienced equally - Black transplant recipients have a 34% higher risk of graft loss, young people aged 14-23 face a 41% higher risk of transplant failure and return to dialysis, and women may experience reduced long term survival benefit.^2,3,4,5,6 A targeted, nurse-delivered transplant clinic is being introduced at Manchester Royal Infirmary through PIONEER, a collaborative working project between Chiesi UK and Ireland (Chiesi) and Manchester University NHS Foundation Trust, to support more personalised post transplant care.   Manchester, UK – 3rd August 2026 – Chiesi and Manchester University NHS Foundation Trust have today announced the launch of a targeted nurse-led transplant clinic at Manchester Royal Infirmary as part of the PIONEER (Post-Transplant Initiative for Optimising Nurse-led Engagement & Empowering Recovery) project. The clinic introduces a nurse-delivered model, providing a more personalised and tailored approach to follow-up care for post-transplant patients from deprived populations in response to growing evidence that outcomes after kidney transplantation are not experienced equally across patient groups.²   For many, a kidney transplant is a life-line, a second chance they have waited for, often for years.⁷ On average, a kidney transplant from a living donor lasts for 20-25 years, while one from a deceased donor lasts 15-20 years.⁸ However, long-term outcomes can vary, with around 30–40% of kidney transplants not lasting beyond 10 years.² When this happens, patients typically require dialysis or a further transplant to restore kidney function.   Mr David Van Dellen, Consultant Transplant & General Surgeon, Manchester Centre for Transplantation, Manchester University NHS Foundation Trust said, “our programme recognises that surgical success is only the beginning - personalised, culturally sensitive post-transplant care is essential to helping each patient achieve the best possible outcome from their transplant. By embedding equity into every stage of the transplant pathway, we aim to ensure that a transplant in Manchester means the same chance of a healthy future for every patient, regardless of background. The PIONEER project is an integral step towards this ambition, providing more personalised support and helping patients protect their transplant for the long-term.”  In the UK, registry data shows that Black kidney transplant recipients experience poorer outcomes than white patients, including higher rates of graft loss and delayed graft function - meaning the transplanted kidney is more likely to fail earlier or take longer to begin working properly after surgery.³ Younger patients are also at increased risk of transplant failure and a return to dialysis, with a 41% higher risk in those aged 14-23 compared to adults in their mid-30s to early 40s.^4,5 Evidence also suggests that women may experience reduced long-term survival benefit following transplantation compared to men.⁶   For many transplant recipients, these challenges are experienced within the wider context of social deprivation. Greater Manchester ranks among the most deprived areas in England, with a significant proportion of neighbourhoods in the most deprived decile.⁹ The clinic will serve patients from across the region, including many from other areas of high socioeconomic deprivation where additional barriers can affect long-term post-transplant care.    “A transplant can be life-changing, but it is not the end of the patient journey - and there is significant variation in the lives recipients go on to lead following a transplant,” said Shish Patel, Senior Director, Medical Affairs at Chiesi UK and Ireland. “Long-term outcomes are influenced by a range of clinical and wider social factors, and more targeted, personalised approaches are essential to improving post-transplant care for transplant recipients.”   Traditionally, post-transplant reviews at Manchester Royal Infirmary have been conducted by surgeons during routine follow-up appointments, reflecting established models of care. The PIONEER clinic introduces a targeted, nurse-led model designed to provide additional time for education, closer monitoring and personalised support, including tailored pharmacological and non pharmacological guidance. This approach also aims to strengthen shared decision making, ensuring patients have meaningful opportunities to share their experiences and priorities as part of their ongoing care. Patients eligible for the clinic are identified and selected by clinical teams at Manchester University NHS Foundation Trust based on a range of criteria.   "Every transplant recipient’s journey is unique, and this innovative nurse-led clinic provides a more personalised approach to post-transplant care,” said Malcolm Greenwood-Morgan, Clinical Nurse Specialist, Manchester University NHS Foundation Trust. “Through holistic assessment, medicines optimisation and tailored support, we can identify challenges and work with patients to address barriers that may affect their long-term health and transplant success. By focusing on what matters most to each patient, the clinic aims to improve treatment adherence, enhance wellbeing and quality of life, reduce health inequalities and empower patients to play an active role in achieving the best possible outcomes from their transplant.”   The PIONEER clinic, which launched today, is a 2-year project and will run until January 2028 and evaluate both clinical and patient-reported outcomes. Insights from the programme will be used to inform future approaches to personalised post-transplant care.    About PIONEER     PIONEER is a collaborative working project between Chiesi and Manchester University NHS Foundation Trust, designed to support more personalised post transplant care for post-transplant patients from deprived populations. As part of the project, a targeted nurse-led clinic is being introduced at Manchester Royal Infirmary, providing additional time for education, monitoring and tailored support alongside routine follow-up care. PIONEER commenced in January 2026 and will run for 24 months.    For more information visit: PIONEER | Chiesi Limited Website   About Manchester University NHS Foundation Trust (MFT)    Manchester University NHS Foundation Trust is the largest NHS Trust in the country and a leading provider of specialist healthcare services. Its ten hospitals are home to 28,000 staff including world class clinicians and academic staff committed to finding patients the best care and treatments. Its hospitals are Manchester Royal Infirmary, Saint Mary's Managed Clinical Service, Royal Manchester Children's Hospital, Manchester Royal Eye Hospital, University Dental Hospital of Manchester, Trafford General Hospital, Altrincham Hospital, Wythenshawe Hospital, Withington Hospital and North Manchester General Hospital. More information is available at www.mft.nhs.uk   About Chiesi Group      Chiesi is a research-oriented international biopharmaceutical group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care. The company’s mission is to improve people’s quality of life and act responsibly towards both the community and the environment.    By changing its legal status to a Benefit Corporation in Italy, the US, France and Colombia, Chiesi’s commitment to creating shared value for society as a whole is legally binding and central to company-wide decision-making. As a certified B Corp since 2019, Chiesi is part of a global community of businesses that meet verified standards for social and environmental business practices. The company aims to reach Net-Zero greenhouse gases (GHG) emissions by 2035.    With 90 years of experience, Chiesi is headquartered in Parma (Italy), with 31 affiliates worldwide, and counts more than 7,900 employees. The Group’s research and development centre in Parma works alongside 6 other important R&D hubs in France, the US, Canada, China, the UK, and Sweden.    For further information please visit Home | Chiesi Limited Website    Media contacts:  Eireann Clapham, Chiesi UK External Communications Specialist  Phone: 07918 613855 Email: e.clapham@chiesi.com   UK-CHI-2600566 | July 2026    References NHS Blood and Transplant. Activity Report 2024/2025.  Available at: https://nhsbtdbe.blob.core.windows.net/umbraco-assets-corp/36694/activity-report-2024-2025-final.pdf.   British Transplantation Society (2023). UK Guideline for the Management of the Patient with a Failing Kidney. Available at: https://bts.org.uk/uk-guideline-for-the-management-of-the-patient-with-a-failing-kidney-transplant/.  Pisavadia B, Arshad A, Chappelow I, Nightingale P, Anderson B, Nath J, et al. Ethnicity matching and outcomes after kidney transplantation in the United Kingdom. Eller K, editor. PLOS ONE. 2018 Apr 13;13(4):e0195038. Hamilton AJ, Plumb LA, Casula A, Sinha MD. Associations with kidney transplant survival and eGFR decline in children and young adults in the United Kingdom: a retrospective cohort study. BMC Nephrology. 2020 Nov 18;21(1). Pankhurst T, Evison F, Mytton J, Williamson S, Kerecuk L, Lipkin G. Young adults have worse kidney transplant outcomes than other age groups. Nephrology Dialysis Transplantation [Internet]. 2020 Jun 1;35(6):1043–51. Available at: https://academic.oup.com/ndt/article/35/6/1043/5847834?login=true.  Katz-Greenberg G, Shah S. Sex and Gender Differences in Kidney Transplantation. 2022 Mar 1 [cited 2022 Jul 18];42(2):219–29. Available at: https://www.seminarsinnephrology.org/article/S0270-9295(22)00019-5/fulltext.  NHS Blood and Transplant. How Long Is the Wait for a kidney? Organ transplantation - NHS Blood and Transplant. 2021. Available at: https://www.nhsbt.nhs.uk/organ-transplantation/kidney/receiving-a-kidney/how-long-is-the-wait-for-a-kidney/. NHS Blood and Transplant. Kidney transplant FAQs. Organ transplantation. Available at: https://www.nhsbt.nhs.uk/organ-transplantation/kidney/is-a-kidney-transplant-right-for-you/kidney-transplant-faqs/.  CDRC. Index of Multiple Deprivation (IMD) | CDRC Data [Internet]. data.cdrc.ac.uk. Consumer Data Research Centre; 2020. Available at: https://data.cdrc.ac.uk/dataset/index-multiple-deprivation-imd.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Chiesi’s first carbon minimal pressurised metered-dose inhalers (pMDIs) for Clenil^® Modulite^® (beclometasone) (100 mcg and 200 mcg). pMDIs, the most widely used inhaler device in the UK, account for 3% of the NHS total carbon footprint.^1,2 Clenil Modulite (beclometasone) (100 mcg and 200 mcg) are the first pMDIs to use HFA-152a (a next-generation, non-PFAS propellant with a low GWP) worldwide, with the UK being the first country to approve these products. Manchester, UK – 21st July 2026 – Chiesi, an international research-focused biopharmaceutical company and certified B Corp, today announces MHRA approval in the UK of Clenil Modulite (beclometasone; 100 mcg and 200 mcg) formulated with a next-generation, non-PFAS, low GWP propellant. These are the first pMDIs to use this propellant worldwide, with the UK being the first country to approve these products.   pMDIs remain the most widely prescribed inhaler device in the UK, accounting for around 70% of the 60 million devices prescribed each year.^1,3 Chiesi’s propellant transition is expected to cut the carbon footprint of their beclometasone products by up to 90% versus that of the current propellant and aims to ensure continuity of care for patients by preserving device choice while addressing the environmental impact of these pMDIs.⁴ Professor Dave Singh, Professor of Clinical Pharmacology and Respiratory Medicine, University of Manchester said, “this milestone represents a significant step forward in sustainable respiratory care. Studies have demonstrated the therapeutic equivalence and tolerability of beclometasone formulated with HFA-152a, versus the existing propellant, HFA-134a, so patients can maintain access to the treatment that works for them while the carbon footprint of these pMDIs is addressed in the background.”⁴ The MHRA approval was informed by pharmacokinetic and safety studies which demonstrated therapeutic equivalence and tolerability between products formulated with HFA-152a, versus those formulated with HFA-134a.^4-10  Orbia Fluor & Energy Materials, whose UK operation is based in Runcorn, is the manufacturing partner for the low GWP propellant used in these products.  Ralph Blom, General Manager, Chiesi UK and Ireland said, “Beclometasone (100 mcg and 200 mcg) are the first in Chiesi’s pMDI portfolio to transition to a low-GWP propellant – a significant milestone as we evolve our respiratory portfolio and advance towards our Net Zero by 2035 goal. Our focus is on delivering innovation that supports both patients and the planet, reducing environmental impact and supporting NHS decarbonisation goals, while preserving choice, access and flexibility in treatment.”   Glossary of terms   HFA: hydrofluoroalkane.  PFAS: per- and polyfluoroalkyl substances. GWP: global warming potential   Net Zero Commitment Chiesi plans to be the first pharmaceutical company to achieve Net Zero greenhouse gas emissions across its entire value chain by 2035, 15 years ahead of the European Climate Neutrality target and 10 years ahead of the NHS 2045 target. This commitment covers all emission scopes. Chiesi’s targets were validated by the Science Based Targets initiative (SBTi) in April 2024.¹¹ The Group has consolidated its greenhouse gas inventory in line with ISO 14064 and the Greenhouse Gas (GHG) Protocol standards, with annual audits carried out by independent third parties.   The transition to the next-generation propellant is one of the most impactful actions in Chiesi’s Net Zero roadmap, as inhaler propellants represent the single largest source of the Group’s greenhouse gas emissions.   About Chiesi Group   Chiesi is a research-oriented international biopharmaceutical group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care. The company’s mission is to improve people’s quality of life and act responsibly towards both the community and the environment.    By adopting the legal form of Benefit Corporation in Italy, the US, France, and Colombia, Chiesi’s commitment to creating shared value for society as a whole is legally binding and central to company-wide decision-making. As a certified B Corp since 2019, Chiesi is part of a global community of businesses that meet verified standards for social and environmental business practices. The company aims to reach Net Zero greenhouse gases (GHG) emissions by 2035.    With 90 years of experience, Chiesi is headquartered in Parma (Italy), with 31 affiliates worldwide, and counts more than 7,500 employees. The Group’s research and development center in Parma works alongside 6 other important R&D hubs in France, the US, Canada, China, the UK, and Sweden.    For further information please visit www.chiesi.uk.com    UK-CLE-2600011 | July 2026   ******    Media contact:  Yasmin Ghariani Head of Communications, UK and Ireland Tel: +44 755 720 5478 Email: y.ghariani@chiesi.com     References   Asthma and Lung UK, 2023. How inhalers affect the environment. [online] Available at: https://www.asthmaandlung.org.uk/symptoms-tests-treatments/treatments/inhaler-choices/how-inhalers-affect-environment. [Last Accessed: July 2026].  NHS England, 2023. Greener NHS: Delivering high quality, low carbon respiratory care. [online] Available at: https://www.england.nhs.uk/greenernhs/2023/02/blog-delivering-high-quality-low-carbon-respiratory-care/. [Last Accessed: July 2026]. NHS England. Improving health outcomes for respiratory patients while reducing carbon emissions. Available at: https://www.england.nhs.uk/greenernhs/whats-already-happening/improving-health-outcomes-for-respiratory-patients-while-reducing-carbon-emissions/. [Last accessed: July 2026]. Chiesi data on file.  Rony F et al 2024, Pulmonary Pharmacology & Therapeutics: Evaluating the pharmacokinetics of beclometasone dipropionate/formoterol fumarate/glycopyrronium bromide delivered via pressurized metered-dose inhaler using a low global warming potential propellant. (https://doi.org/10.1016/j.pupt.2024.102299).  Almeida M et al. Switching to a Low Global Warming Potential Propellant in a Pressurized Metered-Dose Inhaler Does Not Affect the Pharmacokinetics of Combined Beclometasone Dipropionate/Formoterol Fumarate. Available at: https://www.sciencedirect.com/science/article/abs/pii/S0149291826001128 Salvadori M et al 2025, Pulmonary Pharmacology & Therapeutics: The low global warming potential propellant HFA-152a does not induce bronchoconstriction or impair mucociliary clearance (https://doi.org/10.1016/j.pupt.2025.102358).  Singh D et al 2026, Respiratory Medicine: Safety and tolerability of the low global warming potential propellant HFA-152a in patients with asthma receiving beclometasone dipropionate/formoterol fumarate/glycopyrronium: The TRECOS study (https://doi.org/10.1016/j.rmed.2026.108814).  Matturro A et al 2025, An Official Journal of the American Association of Pharmaceutical Scientists: Innovative drug development approach to address the transition to low global warming potential propellant using hydrofluoroalkane 152a, for triple combination pressurized metered dose inhaler products targeting small airways (https://doi.org/10.1208/s12249-025-03057-z).  Rony F, Pittelli MG, Contursi C, Pacchetti I, Calabrò ER, Viganò LV, et al. Impact on beclometasone dipropionate pharmacokinetics when switching to a low global warming potential propellant in a pressurised metered-dose inhaler. Pulmonary pharmacology & therapeutics [Internet]. 2025 Jun;89:102356. Available at: https://pubmed.ncbi.nlm.nih.gov/40090514/.  Chiesi UK Sustainability Report 2024. Available at: https://www.chiesi.uk.com/sustainability/reports. 

European Commission approval expands the indication of lomitapide in the European Union (EU) to include children 5 years of age and older with HoFH, an ultra-rare genetic disorder affecting LDL-cholesterol levels.    PARMA, Italy – June 5, 2026 – Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people living with rare diseases, today announced that the European Commission (EC) has approved lomitapide capsules for use in children 5 years of age and older with Homozygous Familial Hypercholesterolaemia (HoFH), for use alongside diet and other lipid-lowering treatments, including LDL-apheresis where available.    The EC decision follows the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending the expanded indication. Lomitapide has been approved for use in the European Union (EU) for adult patients with HoFH since 2013.   "This European Commission approval marks an important milestone for children living with HoFH and their families," said Mitch Goldman, MD, PhD, SVP Research & Development, Chiesi Global Rare Diseases. "HoFH is a condition that can begin causing irreversible cardiovascular damage from the earliest years of life, and the unmet need remains for younger patients despite existing treatment options. By expanding the indication of lomitapide to children aged 5 years and older, we are offering families and their physicians a meaningful treatment option that is backed by robust clinical evidence. This approval reflects our deepest commitment: ensuring that having a rare disease never means being overlooked at any stage of life, across generations.”   The EC approval is based on evidence from a Phase 3, open-label, single-arm, multicentre study evaluating lomitapide in 43 pediatric participants aged 5 to 17 years with HoFH. The APH-19 study achieved its primary endpoint, demonstrating a mean 53.5% reduction in LDL‑C from baseline at week 24 (p<0.0001). Significant reductions (all p<0.0001) were also achieved in non‑HDL‑C, total cholesterol, VLDL‑C, apolipoprotein B, and triglycerides at week 24 (secondary outcomes). Adverse events were mostly mild, and gastrointestinal and hepatic in nature. Adverse events of special interest were reported for five (12%) patients (gastrointestinal in two patients and hepatic in three). One serious treatment-emergent adverse event was reported (also classed as an adverse event of special interest): an increase in hepatic enzymes, resulting in two dose interruptions, two dose reductions, and a repeated dose escalation. Overall, no new adverse event signals were identified, and the results were consistent with the known profile of lomitapide.¹   About HoFH Homozygous familial hypercholesterolaemia (HoFH) is a rare condition causing very high levels of cholesterol in the body since birth.² In HoFH, the arteries become clogged, with people affected often having more than 10 times the target, or acceptable level of so called bad cholesterol in their blood (LDL-C), leading to severe heart disease, premature atherosclerosis and cardiovascular events.² Early diagnosis and management in HoFH are critical, however, many patients remain undiagnosed and undertreated.^2,3   About lomitapide Lomitapide is a prescription-only medicine used along with a low-fat diet, exercise and other low-density lipoprotein (LDL) lowering medicines to reduce LDL-C in adults and children 5 years of age and older with a type of high cholesterol called homozygous familial hypercholesterolemia (HoFH).⁴ Genetic confirmation of HoFH should be obtained whenever possible. Other forms of primary hyperlipoproteinemia and secondary causes of hypercholesterolaemia (e.g., nephrotic syndrome, hypothyroidism) must be excluded.   About Chiesi Group Chiesi is a research-oriented international biopharmaceutical group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care. The company’s mission is to improve people’s quality of life and act responsibly towards both the community and the environment.   By changing its legal status to a Benefit Corporation in Italy, the US, France and Colombia, Chiesi’s commitment to creating shared value for society as a whole is legally binding and central to company-wide decision-making. As a certified B Corp since 2019, Chiesi is part of a global community of businesses that meet high standards of social and environmental impact. The company aims to reach Net-Zero greenhouse gases (GHG) emissions by 2035.   With 90 years of experience, Chiesi is headquartered in Parma (Italy), with 31 affiliates worldwide, and counts more than 7,500 employees. The Group’s research and development center in Parma works alongside 6 other important R&D hubs in France, the US, Canada, China, the UK, and Sweden.   About Chiesi Global Rare Diseases Chiesi Global Rare Diseases is a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people living with rare diseases. As a family business, Chiesi Group strives to create a world where it is common to have therapy for all diseases and acts as a force for good, for society and the planet. The goal of the Global Rare Diseases unit is to ensure equal access so as many people as possible can experience their most fulfilling life. The unit collaborates with the rare disease community around the globe to bring voice to underserved people in the health care system.   Chiesi Global Rare Diseases Media Contact Sky Striar LifeSci Communications Email: sstriar@lifescicomms.com   References 1.    Masana, L., Zambon, A., Schmitt, C. P., Taylan, C., Driemeyer, J., Cohen, H., Buonuomo, P. S., Alashwal, A., Al-Dubayee, M., Kholaif, N., Diaz-Diaz, J. L., Maatouk, F., Martinez-Hervas, S., Mangal, B., Löwe, S., & Cunningham, T. (2024). Lomitapide for the treatment of paediatric patients with homozygous familial hypercholesterolaemia (APH-19): Results from the efficacy phase of an open-label, multicentre, phase 3 study. The Lancet Diabetes & Endocrinology, 12(12), 880–889.   2.    Borberg H. The lower the better: target values after LDL-Apheresis and semi selective LDL-elimination therapies. Transfus Apher Sci. 2013;48(2):203-206.   3.    Cuchel M, Raal FJ, Hegele RA, et al. 2023 Update on European Atherosclerosis Society Consensus Statement on Homozygous Familial Hypercholesterolaemia: new treatments and clinical guidance. Eur Heart J. 2023;44(25): 2277-2291.   4.    European Medicines Agency. (2025, January 27). Lojuxta, INN-lomitapide: EPAR product information. https://www.ema.europa.eu/en/documents/product-information/lojuxta-epar-product-information_en.pdf    UK-CHI-2600344 | June 2026

-- At ERA 2026, Chiesi will contribute to advancing the scientific understanding of Fabry disease and nephropathic cystinosis through real-world experience and clinical outcomes, supporting the needs of the community of today --   -- Chiesi will also launch the second edition of Find For Rare, an independently assessed, expert led research grant initiative that supports innovative research in Fabry disease, alpha-mannosidosis and nephropathic cystinosis to advance disease understanding and care for generations to come --   PARMA, Italy – June 3, 2026 – Chiesi Global Rare Diseases, a business unit of the Chiesi Group, today announced its participation in the 63rd European Renal Association (ERA) Congress, taking place June 3–6, 2026, in Glasgow, Scotland, re-affirming its long-standing commitment to advancing understanding and care in lysosomal storage disorders (LSDs) over time. At ERA 2026, this commitment comes to life through the Company’s contribution to ongoing scientific dialogue in areas such as Fabry disease and nephropathic cystinosis, while also extending beyond the congress through the launch of the second edition of Find For Rare, its research grant initiative designed to support future innovation in LSDs.   At ERA, Chiesi’s scientific contributions will highlight real-world experience and clinical outcomes across Fabry disease and nephropathic cystinosis, focusing on treatment tolerability and immunogenicity in Fabry disease and nephrology-led multidisciplinary coordination to optimize care and outcomes for cystinosis. Through continued research and collaboration across disciplines, Chiesi Global Rare Diseases strives to create lasting, meaningful impact for the rare disease community for generations to come. This commitment also extends to rare conditions with significant renal impact, such as primary hyperoxaluria type 1 (pH1), which is part of the company’s emerging pipeline focused on advancing innovative approaches for rare kidney diseases.   Building on this commitment, Chiesi Global Rare Diseases will launch, during ERA Congress, the second edition of Find For Rare -an independently assessed, expert led research grant initiative designed to support innovative research in three lysosomal storage disorders: Fabry disease, alpha-mannosidosis and nephropathic cystinosis. By providing funding opportunities for original research projects and fostering collaboration across the scientific community, Find For Rare aims to help advance understanding of these complex conditions and contribute to improving disease management over time. Through this initiative, Chiesi seeks to help enable the research that will shape future care, extending today’s scientific dialogue into meaningful progress for those who come next. For more information, visit www.findforare.com.   “Scientific progress in rare diseases is built over time, through continuous dialogue and collaboration,” said Enrico Piccinini, Senior VP Europe and International, Chiesi Global Rare Diseases. “At ERA, we are proud to contribute to advancing understanding of lysosomal storage disorders. At the same time, with Find For Rare, we aim to go one step further supporting innovative research that can expand knowledge and help shape the future of care for generations to come.”   About Fabry Disease Fabry disease is a rare, inherited lysosomal storage disorder caused by mutations in the GLA gene, which leads to a deficiency of the enzyme alpha-galactosidase A. This deficiency results in an accumulation of a fatty substance called globotriaosylceramide (GL-3) in the body’s cells, affecting the heart, kidneys, skin, nervous system, and other organs.¹  Fabry disease can cause a range of serious signs and symptoms, including fatigue, chronic pain, gastrointestinal issues, decreased ability to sweat, progressive kidney failure, heart complications, and increased risk of stroke.²   The condition affects both males and females and can present from childhood through adulthood, often with delayed diagnosis or misdiagnosis. While Fabry disease is rare, early detection and access to appropriate treatment — such as enzyme replacement therapy or pharmacological chaperone therapy — are critical in managing symptoms and slowing disease progression.¹ About Cystinosis Cystinosis is an ultra-rare genetic condition which affects fewer than 2 people in every million.3 In people with cystinosis, an amino acid called cystine accumulates in a part of the cell called the lysosome, and the cells are unable to remove it.³ When cystine builds up, it forms crystals within lysosomes that can cause long-term damage to organs, including at first the kidneys, eyes, muscles, pancreas, and brain.³ This damage cannot be reversed, but it can be delayed or reduced.⁴ There are three types of cystinosis. We are focusing on Nephropathic Cystinosis (NC), which is the most severe form of Cystinosis (95% of all cases) affecting about 2,000 patients worldwide, ~700 in Europe, ~500 in the US.⁵ Because cystinosis is a multi-organ disease, its symptoms are very broad and diverse. Newborns with nephropathic cystinosis do not present any symptoms, but within the first months of life they often present signs that suggest their kidneys are not working as well as they should. This will result, sooner or later, depending on when the treatment starts, in the need for kidney transplant in all people living with nephropathic cystinosis forms. Patients may also have impaired growth, loss of appetite or rickets.^3,4 Although in nephropathic cystinosis, the kidneys are affected first, almost every organ in the body is at risk of damage,^3,4 Continuous, lifelong cystine accumulation potentially damages all organs and tissues, resulting in severe complications, such as kidney failure, blindness, muscle wasting, central nervous system damage, and reduced lung function.^3,4   About Lysosomal Storage Disorders LSDs are inborn errors of metabolism that are characterised by an abnormal build-up of substances in the body's cells as a result of enzyme deficiencies.⁶ The build-up of these substances can affect different parts of the body, including the skeleton, central nervous system (brain), lungs, heart, and eyes. Whilst there has been progress in clinical knowledge, more research in LSDs can be beneficial.⁶   About Chiesi Group Chiesi is a research-oriented international biopharmaceutical group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care. The Company’s mission is to improve people’s quality of life and act responsibly towards both the community and the environment.   By changing its legal status to a Benefit Corporation in Italy, the US, France and Colombia, Chiesi’s commitment to creating shared value for society as a whole is legally binding and central to company-wide decision-making. As a certified B Corp since 2019, Chiesi is part of a global community of businesses that meet verified standards of social and environmental impact. The Company aims to reach Net-Zero greenhouse gases (GHG) emissions by 2035.   With 90 years of experience, Chiesi is headquartered in Parma (Italy), with 31 affiliates worldwide, and counts more than 7,900 employees. The Group’s research and development center in Parma works alongside 6 other important R&D hubs in France, the US, Canada, China, the UK, and Sweden. About Chiesi Global Rare Diseases Chiesi Global Rare Diseases is a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people living with rare diseases. As a family business, Chiesi Group strives to create a world where it is common to have therapy for all diseases and acts as a force for good, for society and the planet. The goal of the Global Rare Diseases unit is to ensure equal access so as many people as possible can experience their most fulfilling life. The unit collaborates with the rare disease community around the globe to bring voice to underserved people in the health care system. Chiesi Global Rare Diseases Media Contact Sky Striar LifeSci Communications Email: sstriar@lifescicomms.com   References 1)    Mehta, A., & Hughes, D. A. (2024). Fabry disease. In M. P. Adam, S. Bick, G. M. Mirzaa, et al. (Eds.), GeneReviews®. University of Washington, Seattle. 2)    Cleveland Clinic. Fabry disease: Symptoms & causes. 3)    Levtchenko, E., Servais, A., Hulton, S. A., Ariceta, G., Emma, F., Game, D. S., Lange, K., Lapatto, R., Liang, H., Sberro-Soussan, R., Topaloglu, R., Das, A. M., Webb, N. J. A., & Wanner, C. (2022). Expert guidance on the multidisciplinary management of cystinosis in adolescent and adult patients. Clinical kidney journal, 15(9), 1675–1684. 4)    Bäumner, S., & Weber, L. T. (2018). Nephropathic Cystinosis: Symptoms, Treatment, and Perspectives of a Systemic Disease. Frontiers in pediatrics, 6, 58. 5)    Nesterova, G., & Gahl, W. A. (2013). Cystinosis: the evolution of a treatable disease. Pediatric nephrology (Berlin, Germany), 28(1), 51–5 6)    NCBI. Lysosomal Storage Disease. Available at: https://www.ncbi.nlm.nih.gov/books/ UK-CHI-2600340 | June 2026