Press Releases

At the 2024 European Respiratory Society Congress (ERS), Chiesi Group will convene two symposia to highlight the importance of patient centricity in managing asthma and COPD Chiesi Group will present the value for patients in using innovative decentralized elements in clinical trial design, with positive findings regarding the potential to decrease patient burden and increase accessibility Building on recent investments, Chiesi Group will share key progress in its carbon minimal inhaler project, including positive study results and the initiation of a Phase 3 clinical trial   VIENNA, September 4, 2024 – Chiesi Group, an international, research-focused biopharmaceuticals group, is pleased to participate in the ERS Congress 2024, which is being held from 7 to 11 September in Vienna, Austria. The ERS Congress is an annual event that brings together the world’s respiratory experts to showcase the latest advances in respiratory medicine and science.   Giuseppe Accogli, CEO of Chiesi Farmaceutici S.p.A, said, “At Chiesi, we recognize the critical link between a healthy planet and healthy lungs. The climate crisis disproportionately affects people with chronic respiratory diseases. Chiesi is committed to developing innovative treatments that benefit both people and the environment, focusing on engaging patients as well as the healthcare and scientific communities."   Sponsoring patient-centric symposia   As part of its commitment to the care and improvement of the quality of life of people suffering from respiratory diseases, such as asthma and COPD, Chiesi is proud to be welcoming leading experts at two company-sponsored symposia. They will provide important scientific insights on patient perspectives for the management of these diseases:   ‘Holistic approach to improve quality of life of people living with COPD’, 8 September at 12:15. With experts from Switzerland, Germany, Italy and the UK, this symposium will provide a high scientific and patient-centric perspective on the real needs and challenges patients face in their daily lives. It will also present relevant recent evidence from real world data in terms of the effectiveness and benefits of triple inhaled therapy for COPD patients.     ‘Embrace patient perspectives and new real-world evidence towards better asthma management’, 9 September at 12:45. Convening expert presentations in combination with an insightful interview between an asthma patient and a practicing respiratory physician, this symposium will open with an exploration of the role of Small Airways Disease (SAD) in asthma, revealing its significant impact on exacerbations, lung function and quality of life. Exploring the importance of patients as partners in diagnosing and understanding their disease, it will further seek to understand how the burden on patients can be reduced in clinical trials, while better leveraging real world evidence studies to improve understanding of patient needs and how to address them.     Chiesi is also hosting two institutional presentations at its booth within the ERS Congress: ‘Clearing the Air: An Industry Response to Preserve Patients' and Planet's Health’, 10 September 2024 at 12:15. ‘Innovation in Chiesi clinical trials to deliver patient and site focused research’, 10 September 2024 at 13:00.     Patient insights into decentralization of a clinical trial in asthma (TANGO)   Chiesi Group continues to advance asthma and COPD treatment with an inhaled, non-steroidal anti-inflammatory treatment which addresses significant unmet needs in these conditions and is being tested through an extensive and geographically widespread clinical program including 2 pivotal Phase 3 studies in COPD and a Phase 2 study in asthma. The latter, called TANGO, represents an important milestone for the company in its effort to reinforce patient-centricity throughout the steps of development.   As the trial continues to enroll, Chiesi presents findings from a qualitative research study conducted in asthma patients in 4 countries, exploring the TANGO design presented as a hypothetical trial. Findings from the study point to positive acceptance of decentralized approaches when clearly explained and may support reduced patient burden and expanded trial accessibility.   At the ERS Congress, Chiesi will present a poster entitled ‘Patient insight into decentralization of a clinical trial in asthma (TANGO)’ on 10 September from 8:00 to 9:30.   “We are proud that Chiesi is transforming its commitment to patient-centricity into action by utilizing innovative trial tools, such as digitalization and decentralization, through our TANGO clinical trial. In a context where industry leaders are striving to drive increased accessibility and diversity in clinical trials, we will continue to promote approaches that not only reduce the burden on patients but also ensure inclusion and accessibility,” commented Diego Ardigò, Head of Research & Development at Chiesi Group.     Key developments in Carbon Minimal Inhaler Project   Recognising that climate change and health are inextricably connected[1], with the worsening of one, leading to the more severe symptoms in health[2], Chiesi will share key developments in its carbon minimal inhaler project at the ERS Congress. This is an important step in its journey to achieve Net Zero greenhouse gas emissions by 2035, while preserving asthma and COPD patients’ needs.    “Chiesi is committed to transforming its decades-long leadership in respiratory care into cutting-edge and innovative solutions for patients. Our reach extends from pioneering trial designs and sustainable devices to enhanced care pathways, digital innovations, and exploring new indications through strategic partnerships. We are forging a unique path toward achieving comprehensive global leadership in the respiratory care sector,” said Michelle Soriano, Head of Respiratory Franchise (AIR) at Chiesi Group.     The company is proceeding with a long-term phase 3 clinical trial for the new carbon minimal inhalers platform[3], replacing the current hydrofluorocarbon propellant (HFC 134a) with a new, low global warming potential one (HFC 152a). Chiesi has already completed two short-term clinical studies assessing the safety of the new propellant[4] and pharmacokinetics studies on the new carbon minimal fixed double and triple combinations[5],[6]. These studies collectively provided reassuring evidence of a similar performance, safety and tolerability of the new formulations, when compared to the current one, enabling a seamless and safe transition for patients and healthcare systems while significantly reducing environmental impact.   At the ERS Congress, Chiesi will present a poster entitled, ‘Sustaining treatment for asthma and COPD patients while minimizing carbon footprint: effect of HFA-152a and HFA-134a on normal lung mucociliary clearance’ on 10 September from 8:00 to 9:30.     Improvements in respiratory healthcare delivery   Chiesi values its role as an industry partner of the International Respiratory Coalition (IRC) to support engagement with national healthcare systems and the implementation of best practices globally for improved respiratory outcomes. At the ERS Congress, the IRC will host a special session to explore the role of team contributions in respiratory healthcare delivery.     Asthma and COPD Awareness Campaign   Chiesi will also showcase the real lives of asthma and COPD patients in a campaign at the Congress, around Vienna and on social media. Stories of determination and courage in overcoming the limitations imposed by these diseases will, therefore, reach both healthcare professionals and the general public with the aim of generating greater awareness, understanding and empathy.   About the European Respiratory Society ERS is one of the leading medical organisations in the respiratory field, with a growing membership spanning over 160 countries. ERS prioritises science, education and advocacy in order to promote lung health, alleviate suffering from disease and drive standards for respiratory medicine globally.   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 from of Benefit Corporation in Italy, the US and France, Chiesi’s commitment to create shared value for society as a whole is legally binding and central to company-wide decision-making. As a certified B Corp since 2019, we’re part of a global community of businesses committed to continuously measure and improve their social and environmental performance. The company has committed to reach Net-Zero greenhouse gases (GHG) emissions by 2035.   With over 85 years of experience, Chiesi is headquartered in Parma (Italy), with 31 affiliates worldwide and counts more than 7,000 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.   Contacts for the press:   Carla Arrieta Martinez  Head of Global External Communication & Media Relations  Tel: +39 340 8879754  Email: c.arrieta@chiesi.com       Ryan Murray Director, FTI Consulting Tel: +32 477 563565 Email: ChiesiMedia@fticonsulting.com   References [1] https://pubmed.ncbi.nlm.nih.gov/25244362/ [2] https://pubmed.ncbi.nlm.nih.gov/25244362/ [3] Clinical Trials.Comparison Between CHF5993 pMDI 200/6/12,5mg HFA-152a VS CHF5993 pMDI 200/6/12,5mg HFA-134a in Subjects With Asthma (Trecos) (TRECOS). Available from: https://clinicaltrials.gov/study/NCT06264674 [4] Clinical Trials. Study to Assess the Effect of the New HFA-152a Propellant on Mucociliary Clearance. Available from: https://clinicaltrials.gov/study/NCT05875025; Clinical Trials. Study to Compare the Effects of Two Propellants in Adults With Mild Asthma. Available from: https://clinicaltrials.gov/study/NCT05472662 [5] https://www.chiesi.com/en/carbon-minimal-inhalers-milestone/ [6] https://doi.org/10.1016/j.pupt.2024.102299

Chiesi Group's Sustainability Report 2023 highlights impacts on strategic areas such as Patients, Planet, People and Prosperity while anticipating regulatory changes. Patients: Chiesi invested 23.8% of its revenues in research and development and advocated for patients with respiratory conditions, emphasizing the health impacts of air pollution. Planet: Chiesi is progressing towards its goal of Net Zero greenhouse gas emissions by 2035 with a detailed Climate Transition Plan. In 2023, the company earned a Platinum medal in the EcoVadis sustainability assessment. People: Chiesi introduced Global Parenthood Guidelines to contribute to gender equality and increased corporate volunteering hours by 77.5%. Prosperity: Chiesi distributed 77% of the economic value generated to stakeholders—including the local community, capital providers, public administration, employees, collaborators, suppliers, and vendors.   Parma, July 22nd, 2024 – Chiesi, an international research-focused biopharmaceutical group, announces the release of its 2023 Sustainability Report, now available at www.chiesi.com. The report is organized in four key sections: Patients, Planet, People and Prosperity.   Chiesi's business approach is rooted in creating shared value by integrating societal challenges into its core mission. At the end of 2023, Chiesi merged its Shared Value & Sustainability and Global Strategy functions with key cross-functional departments, including Global Business Development, Competitive Intelligence, SKAI (Scientific and External Knowledge Analytics and Insights), COI&C (Center for Open Innovation and Competence), and Digital Health. This new integrated department is named "Strategy, Sustainability, and Growth Unit."   «Uniting these departments and their diverse skills and perspectives, we're pioneering a transversal approach to drive the company's future economic evolution and sustainable growth», shares Siham Imani, the new Head of the Strategy, Sustainability, and Growth Unit. «Through this integrative governance, we utilize our collective expertise to innovate and foster positive societal and environmental impact». PATIENTS – Advancing Innovation and Health Equity to Meet Patient Needs Chiesi’s mission is to develop and market innovative therapeutic solutions that enhance people’s quality of life. In 2023, driven by innovation, the Group invested €720.8 million—23.8% of sales (over €3 billion)—in Research and Development. Chiesi was once again recognized as the leading Italian pharmaceutical company for patents filed at the European Patent Office, with a portfolio of over 6,200 global patents.   In 2023, Chiesi advanced the construction of the Group's Biotech Center of Excellence, set to open in fall 2024. This facility will focus on the development and production of biological medicines, managing the entire process from cell cultivation to drug manufacturing and packaging for global distribution. The initiative aims to attract top talent, enhance Italy's specialized expertise, and strengthen Europe's leadership in biotechnological innovation.   Chiesi introduced a unified Patient Journey Framework to promote a culture of continuous patient engagement and needs assessment, recognizing the unique experience of each patient throughout their care journey. This approach considers the specific aspects of their diseases, the national health systems, and collaboration with physicians.   Aligned with the UN Agenda 2030, Chiesi is working on a Health Equity strategy to reach more patients and improve the standard of care for those living with diseases by addressing gaps in healthcare access. Nearly all Chiesi affiliates now have active projects aimed at achieving health equity.   PLANET – Climate Transition Plan: Achieving Net Zero by 2035 Chiesi is committed to fighting climate change, aiming to achieve Net Zero greenhouse gas (GHG) emissions by 2035. The Group has adopted a robust Climate Transition Plan ahead of the anticipated regulatory requirements of the Corporate Sustainability Reporting Directive (CSRD). This plan serves as a strategic roadmap to meet emission reduction targets and ensures long-term resilience and adaptability in addressing climate-related challenges.   In 2023, compared to our baseline year of 2019, Chiesi achieved a 39% reduction in Scope 1[1] and 2[2] GHG emissions. While our Scope 3 emissions have increased alongside company growth, Chiesi is investing over €350 million in developing a new pressurized metered dose inhaler (pMDI). This initiative aims to slash the current product carbon footprint by 90% by substituting the current propellant with a low global warming potential alternative. Following the completion of two short-term clinical trials to assess the safety of the new propellant, the Group initiated a long-term Phase III clinical safety trial in November 2023. Chiesi targets completing the primary clinical development of its Carbon Minimal pMDI portfolio, utilizing the low GWP propellant HFA 152a, by 2025.   The value chain is crucial in Chiesi’s path to achieving Net Zero by 2035. The Code of Interdependence, co-developed with strategic partners, guides the conduct of suppliers, partners, and distributors. Chiesi has begun implementing EcoVadis as a primary tool to evaluate its suppliers' environmental and social performance, earning itself the EcoVadis Platinum Medal[3] in 2023.   PEOPLE – Prioritizing Wellbeing, Equality, and Community Development Chiesi prioritizes employees’ wellbeing and fosters a positive, respectful work environment. This commitment is underscored by certifications like "Great Place to Work" (GPTW) and "Top Employer."   Through initiatives promoting equal opportunities, fair compensation, and supportive policies, the Group aims to ensure all employees are rewarded equitably. After closing the gender pay gap in 2022, Chiesi became the first Italian pharmaceutical company certified for Gender Equality by Bureau Veritas.   In 2023, Chiesi launched programs to achieve equal career progression for all genders by 2030. These include mentoring programs for women and Global Parenthood Guidelines supporting modern families, with flexible work policies, training for new parents, equitable and extended parental leave, and economic and childcare support.   Recognizing the importance of community health to business success, Chiesi's corporate volunteering program engaged over 2,000 employees (30.5% of the workforce), totaling 16,656 hours—an increase of 77.5% from 2022.   PROSPERITY – Do Good, Do Well, Repeat Demonstrating our commitment to social and environmental responsibility, in 2023 Chiesi distributed 77% of the economic value generated to stakeholders - including the local community, capital providers, public administration, employees, collaborators, suppliers, and vendors. The remaining 23% was reinvested into the company to foster long-term growth.   «At Chiesi, we believe in the principle of 'Do good, do well, repeat.' This philosophy underscores our commitment to creating successful business solutions that benefit society, and reinvesting in impactful initiatives» says Maria Paola Chiesi, Vice Chair at Chiesi Group. «Through continuous innovation and strategic reinvestment, we aim to create a ripple effect of positive change, demonstrating that doing good and doing well are not only compatible but mutually reinforcing».   Chiesi's 2023 Sustainability Report has voluntarily undergone an external assurance process in compliance with the Global Reporting Initiative (GRI). GRI is an independent international standards organization that helps businesses understand and communicate their impacts on Environmental, Social, and Governance (ESG) issues. In response to the new European Corporate Sustainability Reporting Directive, Chiesi Group is committed to enhancing its data collection and reporting processes, giving equal importance to financial and sustainability reporting, and ensuring they are aligned and integrated.   Chiesi: Shaping a Sustainable Legacy and Future Vision «Chiesi is a family-owned company with a history stretching back almost 90 years. This legacy gives us a unique ability to plan for the long term and it addresses the challenges facing current and future generations», says Giuseppe Accogli, CEO of the Group. «On this journey, our aim is not to stand out as a singular entity. Instead, we recognize that effectively addressing the challenges of the future necessitates a collaborative effort among companies, regulators, and suppliers within our industry».   Chiesi has strategically approached sustainable change in recent years. Last year, the company introduced an ambitious Sustainability Strategic Plan spanning 2023-2028, serving as a comprehensive roadmap. Previously, Chiesi Group adopted the legal form of Benefit Corporation (in 2018 in Italy and the U.S.; in 2021 in France) and became a certified B Corp (2019), making environmental, social, and economic sustainability growth drivers of its business development.     References [1] Scope 1: indicates direct GHG emissions from sources owned or controlled by the reporting company. [2] Scope 2: indicates indirect GHG emissions associated with the purchase of electricity or energy for heating and cooling the buildings. [3] Chiesi Achieves Platinum Medal from EcoVadis: https://www.chiesi.com/en/media-hub/news/medal-ecovadis

Design of multi-center study is based on previous Phase 2a clinical data, which showed a decrease in the occurrence of severe bronchopulmonary dysplasia (BPD) OHB-607 has the potential to be the first innovative respiratory therapeutic advance for extremely preterm neonates in over thirty years. Oak Hill Bio and Chiesi Group are collaborating closely to develop OHB-607 under a license and development agreement.   Cary (USA), May 17th, 2024 - Oak Hill Bio, a clinical-stage neonatology and rare disease therapeutics company, and Chiesi, an international, research-focused biopharmaceuticals (Chiesi Group), announced that the first patient has been enrolled in a resumed Phase 2b clinical study to assess the efficacy and safety of OHB-607, an investigational drug candidate being developed to treat complications of extremely premature birth, including bronchopulmonary dysplasia (BPD), a serious condition for which there are no approved therapies.   "As a neonatologist, I’m thrilled that we have restarted this groundbreaking clinical trial previously paused during the out-licensing process to Oak Hill Bio. OHB-607 can potentially improve outcomes for infants born extremely premature," said Victoria Niklas, Chief Medical Officer at Oak Hill Bio. “At Oak Hill Bio, we are committed to advancing the field of neonatology and delivering the best possible care and outcomes to patients together with our partners at Chiesi."    “The restart of this study marks a significant milestone highlighting the shared commitment of Chiesi and Oak Hill Bio to advance solutions for the vulnerable group of extremely premature infants,” commented Diego Ardigò, Global Research & Development Head at Chiesi Group. “Addressing the medical needs of these infants goes beyond scientific inquiry; it's a moral imperative to safeguard their well-being.”    OHB-607 is the recombinant form of human insulin-like growth factor-1 (IGF-1), a key driver of organ growth and development during gestation, complexed with its main binding protein (rhIGFBP-3). A previous Phase 2a study[1]  demonstrated a decrease in severe BPD and the feasibility of OHB-607 infusion. Based on these results and the significant unmet need for therapies to reduce the overall morbidity in extremely preterm infants, OHB and Chiesi are excited to continue the investigation of OHB-607 for the prevention of complications of prematurity.   About the Phase 2b Study   The Phase 2b clinical study is a multicenter, randomized, open-label, two-arm study designed to evaluate the efficacy and safety of OHB-607 compared to standard neonatal care for preventing BPD and other complications of prematurity among infants born extremely premature (between 23 and 28 weeks of gestation). The study will open at multiple centers across the United States and shortly extend to Japan and countries in Europe. It is designed to enroll at least 338 infants.   OHB-607 will be administered by continuous intravenous infusion from 24 hours after birth until 30 weeks postmenstrual age. All infants will simultaneously receive standard neonatal care based on the individual infant’s condition and local guidelines.   The primary endpoint of the study is the reduction in the incidence of severe BPD or death by 36 weeks postmenstrual age compared to extremely premature infants receiving standard neonatal care alone. The study will also evaluate the impact of OHB-607 on weaning from respiratory technology support through 12 months corrected age as a longer-term respiratory outcome measure, the impact on neurodevelopment, and the incidence of other complications of prematurity, including intraventricular hemorrhage (bleeding in the brain) and retinopathy of prematurity (vision impairment and blindness). The study will utilize a modified National Institute of Child Health and Human Development (NICHD) score to define BPD severity grading, allowing the comparison of infants with the most severe form of the disease.   For additional information and to learn more about the trial registration, please visit https://clinicaltrials.gov/study/NCT03253263.    About OHB-607    OHB-607 is the recombinant form of human insulin-like growth factor-1 (IGF-1) complexed with its main binding protein (rhIGFBP-3). IGF-1 is a key driver of the growth and gestational development of vital organs, including the lung, eye, and brain. Mothers are the primary source of IGF-1 for the developing fetus until about 30 weeks gestational age, when the fetal liver takes over. As a result, infants born before 28 weeks of gestational age have low levels of IGF-1, which is believed to result in the failure of organs to grow and develop normally.   Following preterm birth, serum IGF-1 levels decrease rapidly and remain low for the first weeks of life relative to corresponding fetal levels in utero. Longitudinal studies report an association between lower serum IGF-1 levels at birth in extremely preterm infants and an increased risk of BPD, retinopathy of prematurity, and neurodevelopmental and overall growth impairment. This provides a rationale for evaluating OHB-607 to restore IGF-1 to levels that would have been present in utero in a full-term pregnancy, to potentially support the normal growth and development of the lung and other organs[2].   OHB-607 has the potential to be the first major respiratory therapeutic breakthrough for extremely preterm infants since lung surfactants were first approved more than 30 years ago.     About Bronchopulmonary Dysplasia (BPD[3])   BPD is the most common complication of prematurity, resulting in chronic lung disease affecting, on average, 40-50% of infants born at less than 28 weeks of gestational age. Beyond BPD’s direct impact on lung function, it can also lead to greater mortality, increased hospitalization, and cost burden, as well as long-term respiratory morbidity and neurodevelopment disability.     While the pathogenesis of BPD is multifactorial and not completely understood, gestational age is the most significant predictor of BPD and chronic lung disease following preterm birth. Additional factors, including birth weight, growth restriction, lung function, and gender, may also contribute to the severity of BPD. Unfortunately, the care practices necessary to sustain life after preterm birth result in direct and bystander injury to the developing lung, particularly in infants requiring high levels of oxygen therapy and invasive ventilation for extended periods. OHB-607 has the potential to help the lung develop normally, reducing the need for respiratory support, which could, in turn, reduce the severity of BPD and its long-term outcomes.   About Oak Hill Bio    Oak Hill Bio Ltd is a clinical-stage neonatology and rare disease therapeutics company developing life-changing medicines for extremely preterm infants and patients suffering from rare autoimmune diseases. The company, with operations in the United States and the United Kingdom, is advancing a pipeline of six promising clinical-stage and preclinical investigational therapeutics. For more information, visit the company’s website at www.oakhillbio.com.   About Chiesi Group   Chiesi is 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, and France, 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, we’re 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 over 85 years of experience, Chiesi is headquartered in Parma (Italy), with 31 affiliates worldwide, and counts more than 7,000 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.com   Contacts for Media:   Chiesi Group   Carla Arrieta Head of Global External Communications & Media Relations +393408879754 mediarelations@chiesi.com   Gentry Lassiter Sr. Director Communications & Public Affairs US  Office +1 (888) 466-6505 x1549 us.mediarelations@chiesi.com   Oak Hill Bio Investors: Josh Distler Oak Hill Bio Josh.distler@oakhillbio.com   Clinicians: Victoria Niklas Oak Hill Bio Victoria.Niklas@oakhillbio.com   Media: Chris Railey Ten Bridge Communications chris@tenbridgecommunications.com     [1] Ley D, Hallberg B, Hansen-Pupp I, et al. rhIGF-1/rhIGFBP-3 in Preterm Infants: A Phase 2 Randomized Controlled Trial. J Pediatr. 2019;206:56-65.e8. doi:10.1016/j.jpeds.2018.10.033 [2] Kramer BW, Abman S, Daly M, et al. Insulin-like growth factor-1 replacement therapy after extremely premature birth: An opportunity to optimize lifelong lung health by preserving the natural sequence of lung development. Paediatr Resp Rev 2023 May 6:S1526-0542(23)00020-9 [3] Thébaud B, Goss KN, Laughon M, et al. Bronchopulmonary dysplasia. Nat Rev Dis Primers. 2019 Nov 14;5(1):78

The collaboration is underpinned by a shared commitment to advancing medical science and improving patient care through joint research, development, and innovation efforts Parma, 14 May 2024 – Chiesi Group, a research-oriented international biopharmaceutical group, proudly announces the signing of a memorandum of understanding with Karolinska Institutet, a medical university. The agreement solidifies a commitment between the two organizations to collaborate on joint efforts aimed at advancing therapeutic solutions for urgent health challenges.   The landmark collaboration between Chiesi and Karolinska Institutet (KI), will accelerate research and development initiatives for respiratory diseases, rare diseases, diseases of prematurity, and other specialty care indications.   Chiesi Group and KI will exchange ideas, expertise, and resources to accelerate the translation of scientific discoveries into tangible healthcare solutions. Their collaboration is underpinned by a shared commitment to advancing medical science and improving patient care through joint research, development, and innovation efforts.     Fabrizio Conicella, Head of Chiesi’s Center for Open Innovation and Competence, said: “We believe that this partnership with such a world-renowned academic center of excellence will provide significant opportunities to not only accelerate our pipeline but to explore and establish novel innovative ways of working between academia and industry. ”   Mark Parry-Billings, Head of Drug Development at Chiesi and Site Head of Chiesi’s R&D operations based in the Karolinska Science Park, stated, “We are delighted to advance our work with KI through this collaborative agreement, which will leverage past successes and form a platform for a close and dynamic research and development partnership, in a series of focused scientific disciplines, including for example in the field of translational medicine.”   Åsa Wheelock, Board member of the Chiesi-KI alliance and Head of the Respiratory Medicine Unit, Department of Medicine Solna, at KI declared, “We are thrilled to embark on this strategic collaboration with Chiesi Group, a partnership that embodies our shared commitment to advancing scientific research and improving patient care. KI and Chiesi have a long and successful track record of collaborations in the field of respiratory disease and neonatology. This alliance provides an enhanced platform to expand our collaborations beyond our ongoing joint efforts on sub-grouping of patients in the asthma-COPD spectrum. As such, this collaboration underscores Karolinska Institutet's dedication to translating cutting-edge research into tangible solutions that address the needs of patients worldwide.”   Through this partnership, Chiesi Group and KI are poised to drive innovation, accelerate scientific discovery, and ultimately improve patient outcomes in areas of high unmet need.     About Chiesi Group   Chiesi is 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, and France, Chiesi’s commitment to create shared value for society as a whole is legally binding and central to company-wide decision-making. As a certified B Corp since 2019, we’re 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 over 85 years of experience, Chiesi is headquartered in Parma (Italy), with 31 affiliates worldwide, and counts more than 7,000 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 www.chiesi.com About Karolinska Institutet (KI)   As one of the world’s foremost medical universities, KI accounts for the single largest share of all academic medical research conducted in Sweden. KI also offers the country’s broadest range of education in medicine and health sciences. The research spans the entire biomedical field – from basic experimental research to clinical studies in collaboration with the health care system.

Strategic collaboration to leverage Chiesi's legacy of respiratory leadership and Gossamer Bio's development expertise in pulmonary hypertension. Gossamer to receive $160 million development reimbursement payment and eligible to receive up to $146 million in regulatory and $180 million in sales milestones. 50/50 commercial profit split in US and global development cost sharing arrangement. Chiesi obtains exclusive ex-US development, manufacturing, and commercial rights, with Gossamer to receive mid-to-high teens royalties on net sales. Gossamer and Chiesi plan to initiate in mid-2025 a Phase 3 trial of seralutinib in PH-ILD in addition to the ongoing Phase 3 trial in PAH   SAN DIEGO, CA and PARMA, ITALY, May 6, 2024 - Chiesi Farmaceutici S.p.A (“Chiesi Group”), an international, research-focused biopharmaceutical group, and Gossamer Bio, Inc. (“Gossamer”) (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary hypertension, today announced that they have entered into a global collaboration and license agreement to develop and commercialize seralutinib.   This global collaboration combines the strengths of both Chiesi and Gossamer to support ongoing work in pulmonary arterial hypertension (PAH) and to accelerate development in pulmonary hypertension associated with interstitial lung disease (PH-ILD), with the aim of expanding the seralutinib franchise to reach more patients with pulmonary hypertension world-wide. Patients will benefit from both Chiesi’s expertise in global respiratory, rare disease, and inhaled drug development and commercialization and Gossamer’s world-class PAH and PH-ILD development and commercialization teams.   “Seralutinib is a potential paradigm shifting therapy in PAH and PH-ILD, and we could not be more excited to partner with Gossamer to develop and bring this therapy to patients world-wide,” said Giuseppe Accogli, CEO of Chiesi Group. “Gossamer shares Chiesi’s commitment in using innovation to promote the health and well-being of people around the world and we are proud to add this collaboration as a key pillar to our next phase of growth.”   “This partnership with Chiesi allows us to meaningfully deepen and rapidly accelerate our investment in seralutinib as a potential treatment for PAH, PH-ILD, and other indications of high unmet medical need,” said Faheem Hasnain, Co-Founder, Chairman and CEO of Gossamer. “We are particularly thrilled that this collaboration enables seralutinib to move directly into a Phase 3 trial in PH-ILD, an indication with a paucity of available treatments, and a disease which we believe seralutinib is specifically designed to address.”   Seralutinib is an inhaled PDGFRα/β, CSF1R, and c-KIT inhibitor designed to be delivered via dry powder inhaler for the potential treatment of pulmonary hypertension. Following the positive readout of the Phase 2 TORREY Study in patients with PAH, Gossamer initiated the Phase 3 PROSERA Study in 2023. Gossamer and Chiesi plan to initiate a global Phase 3 registrational study in PH-ILD in mid-2025 and to evaluate seralutinib in additional indications of high unmet medical need.   Under the terms of the agreement, Gossamer will continue to lead global development of seralutinib in PAH and PH-ILD, and the companies will evenly split development costs, except with respect to the PROSERA Study, for which Gossamer will remain financially responsible. In the US, the companies will evenly share commercial profits and losses. Gossamer will lead US commercialization, including contributing 50 percent of commercial activities and booking of sales for PAH and PH-ILD. Chiesi will lead US commercialization for additional indications. Chiesi will have the exclusive right to commercialize seralutinib outside of the US and will pay Gossamer an escalating mid-to-high teens royalty on net sales outside of the US.   Chiesi will pay Gossamer $160 million as a development reimbursement. Additionally, Gossamer will be eligible to receive up to $146 million in regulatory milestones and $180 million in sales milestones.   Chiesi is devoted to advancing research, exploration, and advancement of groundbreaking treatments in the field of respiratory diseases, which holds a paramount position in our organization's strategic agenda. This collaboration introduces a significant and valuable addition to Chiesi's research and development portfolio, aligning perfectly with our strategy to bring innovative treatments to patients with unmet needs and support the healthcare community through transformative solutions.     About Chiesi Group Chiesi is 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, and France, Chiesi’s commitment to create shared value for society as a whole is legally binding and central to company-wide decision-making. As a certified B Corp since 2019, we’re 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 over 85 years of experience, Chiesi is headquartered in Parma (Italy), with 31 affiliates worldwide, and counts more than 7,000 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 www.chiesi.com   About Gossamer Bio Gossamer Bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary arterial hypertension. Its goal is to be an industry leader in, and to enhance the lives of patients living with, pulmonary hypertension.

Highlights from Chiesi Group’s 2023 financial report: Sales increased to over €3 billion, up 10% compared to 2022 (+12% @CER), driven by the Rare business unit growth (65% @CER), and steady growth of all products in all its Regions 24% of 2023 sales were devoted to R&D to create innovative therapeutic solutions, focused on the needs of patients, caregivers and the entire healthcare community Profitability remained around 30% for the fourth consecutive year enabling the Company to pursue its expansion strategy.   Parma (Italy), April 22nd, 2024 – In 2023, Chiesi, a research-oriented international biopharmaceutical group headquartered in Parma (Italy), with 31 affiliates worldwide, showcased the efficacy of its operating model centred around shared value, sustainability, and high ethical standards. Through this approach, Chiesi continues to deliver tangible benefits for patients, people, and the planet. 2023 business growth serving patient needs Chiesi reached over €3 billion in sales – a 10% growth (+12% @CER) on the previous year – maintaining an EBIDTA of approximately 30% for the fourth consecutive year.   Group Revenues 2022 2023 Growth @CER Total €2,749M €3,026M 12% Air €1,634M €1,708M 6% Rare €332M €540M 65% Care €783M €778M 2% Financials 2022 2023 Growth EBITDA €827M €893M 8% EBITDA % 30.1% 29.5%     In 2023, the Company reinforced its strong momentum across geographies and business areas. At constant exchange rates (@CER), growth was observed in all three of the Group’s business areas (AIR - respiratory diseases, RARE - rare and ultra-rare diseases, and CARE - specialty care, neonatology and consumer healthcare) and across all its Regions (US grew at 25%, Europe at 7% and China and International at 22%). The focus on innovation continues to be central in the growth of Chiesi Group. R&D investments reached almost 24% of total sales in the year, fuelling both the internal pipeline and accelerating external collaborations.   Highlights from the therapeutic areas AIR AIR Franchise encompasses products and services for the treatment of respiratory diseases. It is the largest franchise, representing more than 56% of sales and growing 6% @CER. Chiesi’s fixed triple formulation for the treatment of asthma and COPD (Chronic Obstructive Pulmonary Disease) achieved a 27% @CER growth. Also, in 2023 it was introduced in China, presenting a pivotal opportunity for growth and expanding access to treatment for more patients. In March 2023, Chiesi enriched its AIR portfolio thanks to the partnership with Affibody AB to develop and commercialize innovative treatments for respiratory diseases. In November 2023, Chiesi signed a License Agreement with Haisco Pharmaceutical to develop, manufacture, and commercialise a novel solution for bronchiectasis.   RARE The RARE Diseases Business Unit, the latest addition to Chiesi’s portfolio, is dedicated to providing advanced treatments for individuals living with rare or ultra-rare genetic diseases. It achieved over €500 million in sales propelled by strong organic expansion and the strategic acquisition of Amryt Pharma Plc in April 2023. This landmark achievement marked a significant milestone in the Company’s pursuit of inorganic growth during a record year for investments, further broadening the spectrum of rare disease areas served and extending our impact to more patients in need. In February 2023, FDA approved the first pharmacological therapy for the treatment of non-central nervous system manifestations of Alpha-Mannosidosis – an ultra-rare progressive disease with wide range of symptoms - in adult and paediatric patients. In 2023, Chiesi’s enzyme replacement therapy indicated for the treatment of adults with confirmed Fabry disease was approved in Europe, the US, and the UK. In December 2023, a topical gel for the treatment of Epidermolysis Bullosa – already available in Europe and in the UK - also received FDA approval.     CARE CARE Franchise (specialty care, neonatology, and consumer healthcare) continued to grow consistently across Chiesi Regions, with sales up 2% @CER. Chiesi’s natural surfactant, employed in treating premature newborns with RDS (Respiratory Distress Syndrome), continued to excel, demonstrating a 6% @CER growth and reaffirming its role as an effective solution for the premature infants. At the end of 2023, Chiesi and Oak Hill Bio achieved an agreement to develop, manufacture, and commercialise an investigational drug candidate tailored to address the complications of extremely premature birth. This milestone underscores the Company unwavering commitment to advancing innovative solutions and improving outcomes for the most vulnerable newborns. The Company consolidated the growth of critical care portfolio, with a 22% @CER increase (especially in the US, where it was driven by two cardiovascular products designed for acute hospital setting).   Chiesi, the Place to be Chiesi reached significant milestones related to its commitment to people well-being. For the third consecutive edition, the Company has been certified as a Great Place to Work™, now spanning across 27 countries from the initial eight in 2019. Progressing on its Gender Equality Global Challenge in adherence with applicable legal frameworks and principles of fairness and justice, Chiesi maintains a Zero Global Gender Pay Gap and was recognised with the Fair Pay Certification early in 2024.   Our commitment to Planet Chiesi remains steadfast in its pledge to achieve Net-Zero greenhouse gases (GHG) emissions by 2035. In 2023, the Company reinforced its dedication to combating climate change by actively engaging with the Carbon Disclosure Project (CDP), where it earned an A- rating in the Climate Change CDP questionnaire. Furthermore, Chiesi's commitment to sustainability was recognized with a Platinum medal in the Ecovadis sustainability assessment: Ecovadis, a global leader for sustainability ratings, evaluates companies’ performance across environment, ethics, labour rights, and sustainable procurement criteria. These accomplishments underscore Chiesi Group's resolute commitment to high sustainability and ethical standards, bolstered by its governance model founded on transparency and accountability as both a Benefit Corporation (in Italy, the US and France) and a B Corp certified company.   Commenting on the 2023 performances, Giuseppe Accogli, CEO of Chiesi Group, said: “The Company went through a significant transformation, adopting a new operating model and adapting to market dynamics by creating business Franchises and geographical Regions. This organizational design aims to make Chiesi Group even more efficient and effective on a global scale. This commitment is also reflected in the growing number of top managers with valuable international and multicultural expertise and in our ability to attract talents to promote long-term prosperity and development. The accelerated evolution experimented by the Chiesi Group in 2023 was consistent with our shared value approach. This means addressing social challenges and business opportunities together, fostering a culture of inclusion, respect, and empowerment among Chiesi Group’s 7,000 teammates”.   Looking to a bright 2024 In 2024, the Company aims for a steady growth at a mid-to-high single-digit rate, building on four years of consistent profitability at 30%. With substantial cash generation and ongoing potential for investment, Chiesi Group is well-positioned to fuel growth through strategic acquisitions and new R&D investments. Enhancing its commitment to patient care, the Company will expand its value proposition in AIR, RARE and CARE, while strengthening its pipeline. Moreover, Chiesi is set to inaugurate operations at its new Biotech Center of Excellence, in Parma, Italy, marking a significant leap in capabilities for biologic drugs development and production. In alignment with its dedication to sustainability, in 2024 Chiesi plans to establish new Net-Zero GHG emissions reduction targets in line with the Science Based Target initiative (SBTi) Corporate Net-Zero standard. Chiesi Group remains steadfast in supporting its employees as parents and caregivers and in offering continuous training and development opportunities to nurture future leaders. Positioned at the forefront of industry trends, Chiesi is committed in delivering relevant value, enhancing patient outcomes, and creating shared value across the community, the environment, and the stakeholders.     About Chiesi Group Chiesi is 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, and France, Chiesi’s commitment to create shared value for society as a whole is legally binding and central to company-wide decision-making. As a certified B Corp since 2019, we’re 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 over 85 years of experience, Chiesi is headquartered in Parma (Italy), with 31 affiliates worldwide, and counts more than 7,000 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.