Chiesi Farmaceutici is fully committed to the care and improvement of the quality of life of people suffering from respiratory diseases including asthma and COPD (Chronic Obstructive Pulmonary Disease). Asthma and COPD are characterised by a reduction in the respiratory flow although they are driven by a different pathophysiological pathway.
According to the latest estimates of the WHO (World Health Organisation), there are 235 million people across the globe – mainly children - suffering from asthma, whilst 64 million people suffering from COPD (WHO 2004 estimate), which is predicted as being the third leading cause of mortality by 2030. If measures aimed at reducing disease-related risk factors – i.e. cigarette smoke - are not adopted, it is estimated that COPD-related deaths will increase by 30% in the next 10 years1.
In the search for continued improvement in the health of patients, Chiesi Farmaceutici researches and develops new therapeutic solutions based on the innovative formulation technology Modulite®, which allows the creation of spray solutions(pMDI, pressurised Metered Dose Inhaler) for inhalation able to deliver extrafine particles. Chiesi Farmaceutici has patented and introduced into the market a dry powder-based medical device for inhalation(DPI, dry powder inhaler), NEXThaler, which is also able to deliver extrafine particles.
ASTHMA AT A GLANCE
Asthma is a chronic inflammatory disease characterised by recurrent respiratory symptoms such as breathlessness, cough and wheezing as well as chest tightness. In normal conditions, the air is free to move within our lungs through a complex conductive system also called airways. In specific conditions and when asthmatic patient conditions are uncontrolled, the airways are more prone to inflammation, triggering an asthma attack. As a consequence, several changes occur including bronchoconstriction, thickening of the internal mucosa and plugging of small airways, which in turn make breathing more difficult. However, these clinical manifestations are basically reversible, although varying greatly over time or between patients. Generally, the asthmatic status tends to deteriorate during the night or the early hours of the morning. Although it is not possible to recover from asthma, optimal disease control is achievable, ensuring patients maintain an adequate quality of life. But what causes asthma? An asthmatic attack is triggered when a susceptible person encounters irritants. In particular, predisposing factors are genetic (which explains the greater incidence in those related to sufferers), the presence of allergies, female gender, obesity and ethnic origin. At the same time, factors such as allergens, professional pollutants, tobacco smoke, environmental pollution and airway infections may trigger an asthmatic attack if inhaled in significant quantities. Asthma occurs more frequently in children and adolescents, although in recent years diagnosis in adults and the elderly are becoming more and more frequent.2
CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) AT A GLANCE
COPD is a respiratory disease characterised by a persistent bronchial obstruction (irreversible), associated with an increased chronic inflammatory response of the airways to noxious particles or gas. The classic symptoms associated with COPD are dyspnoea, chronic coughing and chronic productive sputum. In some cases, an acute worsening of the abovementioned symptoms may occur, triggering COPD exacerbation. A double mechanism is at work in the bronchial obstruction in COPD patients: on one hand, an inflammation of the small airways together with the thickening of the airways walls and increased airflow resistance may occur, on the other, a progressive destruction of lung parenchyma (emphysema) associated with the loss of elastic retraction of the lung may take place. It is important to underline that both mechanisms may coexist, leading to a global airflow reduction throughout the lungs. What are the main risk factors associated with COPD? First of all, there are genetic risk factors that may predispose some subjects to developing the disease. The most important risk factor is cigarette smoke, as well as exposure to domestic pollutants (linked to the cooking of food or gas emitted from biofuel combustion) or environmental pollution. Secondary factors are age, sex, socio-economic status, respiratory infections, asthma or chronic bronchitis. In general, COPD patients are more prone to developing cardiovascular diseases, osteoporosis, diabetes, lung cancer and bronchiectasis, which in turn increase hospitalisation and/or risk of death. Unlike asthma, COPD is a late onset disease, being more common among adults (it does not exist among young patients), since its development involves a slow and progressive exposure to risk factors.3
CHIESI POSITION ON F-GASES USAGE IN PHARMACEUTICAL PRODUCTS
We share authorities’ concerns related to the environmental impact of Hydrofluorocarbon (HFC) propellants used in pressurized metered dose inhalers (pMDIs) – hydrofluoroalkanes (HFA) 134a and 227ea – and we are committed to be the first pharmaceutical company leading the way towards carbon minimal pMDI solutions that will preserve patients’ choice and wellbeing. This despite the very limited contribution of HFAs for pharmaceutical use compared to the total F-gases use1.
INNOVATION IS THE KEY
We believe that the development and the transition to pMDIs containing a low Global Warming Potential (GWP) propellant (reducing pMDIs carbon footprint of pMDIs by 90%2) offers environmental benefits and ensure patient health far beyond any other option such as switching to dry powder inhalers (DPIs) – which do not contain propellants.
In November 2019, Chiesi Group signed the first commercial agreement with propellant gas supplier Koura, to secure supply of HFA 152a (1, 1-difluoroethane) which is classified as a low GWP propellant (its GWP value is ten times lower than HFA 134a, the propellant currently used3).
Chiesi has a 5-year, €350 million investment plan to introduce the first carbon minimal pMDI inhaler by 2025.
This will bring the environmental impact of the Chiesi pMDIs down to the level of DPIs2 whilst ensuring patient choice and wellbeing.
Restrictive and short-term approaches to reduce the environmental impact by limiting the use of pMDIs risks undermining the innovation ecosystem around carbon minimal pMDIs. This not only risks, impeding patient access to the innovative solutions that they need, but also risks disincentivizing innovation to achieve such ambitious environmental objectives.
PATIENT HEALTH WILL ALWAYS BE AT THE CENTRE
Indeed, the optimal choice of the most suitable inhaled therapy is a complex decision taken between doctor and patient. A proportion of patients rely on using products delivered through a pMDI to manage their condition, including those unable to use DPIs (e.g. low inspiratory flow, children)4.
As such, products delivered though a pMDI need to remain a treatment option for asthma and COPD patients, particularly for those who rely on pMDI treatments they trust to manage their condition and for those for whom pMDIs are the only suitable option1, 5, 6, 7.
Patient choice and health are at the heart of Chiesi’s portfolio and pipeline and we are committed to ensuring patient access to all available treatments for respiratory conditions (both in pMDIs and DPIs).
CHIESI LONGSTANDING COMMITMENT TO SUSTAINABLE INNOVATION
Chiesi Group is committed to actively and increasingly operate its business in a way that ensures long-term sustainability, as defined in the United Nations 2030 Agenda for Sustainable Development. Officially Registered as a Benefit Corporation since December 2018 and as the largest global pharmaceutical group to be awarded B Corp™ Certification in June 2019, Chiesi is conscious of the role that every member of society, companies included, can play to contribute to global changes that can no longer be postponed. For these reasons, Chiesi has also committed to become carbon neutral by 2035.
In this regard, we are taking steps to minimize the environmental impact of our pMDI and DPI products, including assessing options for better management throughout their lifecycle. According to official certification, the carbon footprint of Chiesi products both in pMDI with HFA 134a and DPI is in the lower range, or is even lower, than the corresponding average inhalers as a result of both formulation and device optimization8.
From the early beginnings of the Montreal Protocol in 1990, Chiesi was amongst the first to openly support the phasing out of the production of substances responsible for ozone depletion. Chiesi has radically improved the environmental impact of its respiratory portfolio, being among the first companies to move away from Chlorofluorocarbons (CFC) to HFA 134a-based pMDI technologies.
BACKGROUND INFORMATION ON F-GASES
Pressurized metered dose inhalers (pMDIs) contain hydrofluorocarbon (HFC) propellants, which are recognised as greenhouse gases that can have high or very high global warming potentials (GWPs).
As such, HFCs are the object of a phase-down strategy agreed by EU regulation No 517/2014 (2nd F-gas Regulation) and the Parties to the Montreal Protocol in the 2016 Kigali Amendment. The Kigali Amendment entered into force on 1st January 2019, with different schedules for different country groups. The aim of the phase-down is to encourage use of low GWP alternatives and to reduce consumption and emissions of high GWP HFCs.
Currently, the EU regulation No 517/2014 (2nd F-gas Regulation) recognises an exemption for HFCs for pharmaceutical use (pMDIs), and the Kigali Amendment reports “Currently MDIs are being excluded from HFC phase-down regulations, such as in the EU, as the costs and timescales to develop alternatives to HFCs in MDIs are very high/long. This situation may change if an alternative low GWP fluorocarbon can be identified (trials are on-going)”.
It is important to underline the very limited contribution of HFAs for pharmaceutical use compared to the total F-gases use (According to 2014 MTOC report, HFC emissions from MDIs are estimated as about 0.03 per cent of annual global greenhouse gas emissions).
- Usmani O.S., Scullion J., Keeley Our planet or our patients – is the sky the limit for inhaler choice? The Lancet Respiratory Medicine (2018).
- Jeswani HK, Azapagic A. Life cycle environmental impacts of inhalers. Journal of Cleaner Production (2019);237: 117733.
- IPCC Fifth Assessment Report (AR5), 2014. Available: https://www.ipcc.ch/report/ar5/syr/
- Bonini M. & Usmani O.S. The importance of inhaler devices in the treatment of COPD. COPD Research and Practice (2015), p. 1-9.
- Dekhuijzen P.N.R., Vincken W., Virchow J.C., Roche N., Agusti A., Lavorini F., van Aalderen W.M., Price D.Prescription of inhalers in asthma and COPD: Towards a rational, rapid and effective approach. Respiratory Medicine (2013), Vol. 107, p. 1817-1821.
- Lavorini F. Inhaler drug delivery in the hands of the patient. Journal of aerosol medicine and pulmonary drug delivery (2014), Vol. 27, N. 6, p.414-418.
- Dekhuijzen P.N.R., Lavorini F., Usmani O.S. Patients’ perspectives and preferences in the choice of inhalers: the case for Respimat®or HandiHaler®(2016), Vol. 10, p. 1561-1572.
- Carbon Footprint Italy 2019. Available: http://www.carbonfootprintitaly.it/p-2019-0008/