Enter at least 3 characters
Home > Therapeutic areas > Respiratory

Autorizzo al trattamento dei miei dati personali
ai sensi del D.L. 30 giugno 2003 n. 196
Edit email address
Invalid email
Your request has been sent successfully
Authorize the processing of personal data

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

Reference List

  1. who.int/en
  2. ginasthma.org
  3. goldcopd.com

 

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).

 

Sources

  1. Usmani O.S., Scullion J., Keeley Our planet or our patients – is the sky the limit for inhaler choice? The Lancet Respiratory Medicine (2018).
  2. Jeswani HK, Azapagic A. Life cycle environmental impacts of inhalers. Journal of Cleaner Production (2019);237: 117733.
  3. IPCC Fifth Assessment Report (AR5), 2014. Available: https://www.ipcc.ch/report/ar5/syr/
  4. Bonini M. & Usmani O.S. The importance of inhaler devices in the treatment of COPD. COPD Research and Practice (2015), p. 1-9.
  5. 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.
  6. 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.
  7. 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.
  8. Carbon Footprint Italy 2019. Available: http://www.carbonfootprintitaly.it/p-2019-0008/
PRODUCTS
Atimos®

It is a Modulite®-based spray formulation (pMDI) of formoterol fumarate, a long-acting β2 agonist (LABA). Atimos is indicated for the prevention and treatment of the bronchospasm (1-2 puffs twice-daily) in patients with asthma and COPD, in both adults and children over 6 years of age.

Clenil®

The Clenil brand includes a range of beclomethasone-containing products, a corticosteroid, in a variety of formulations indicated for a range of inflammation-driven respiratory diseases, including asthma, allergic rhinitis and bronchostenosis conditions: Clenil Spray (pMDI, Modulite®), Clenil A (sterile suspension for nebulisation), Rinoclenil (nasal spray, suspension).

Foster® Spray & Foster®

It is a fixed combination for inhalation of beclomethasone dipropionate (anti-inflammatory) plus formoterol fumarate (bronchodilator). The spray-formulated product (pMDI, Modulite®) releases extra-fine particles. Foster is also available on the market as a dry powder formulation (DPI) for inhalation, dispensed in extra-fine particles by the NEXThaler® device.

The product is indicated for the treatment of asthma both as a maintenance (1 or 2 puffs twice-daily) and MART posology schemes (Maintenance and Reliever Therapy) and as maintenance in COPD (2 puffs twice-daily).

Foster is currently commercialized in more than 55 countries across the globe.

Trimbow® Spray

Trimbow Spray is a fixed combination of beclomethasone dipropionate (corticosteroid), formoterol fumarate (long acting β2 agonist) and glycopirronyum bromide (long acting muscarinic antagonist). The spray-formulated product (pMDI, Modulite®) releases extra-fine particles. The product is indicated for the treatment of COPD with a posology of 2 puffs twice-daily. Trimbow Spray is approved in EU and in a number of non-EU countries.

Primary care
RHEUMATIC AND MUSCULOSKELETAL DISEASES

RHEUMATOID ARTHRITIS

Rheumatoid arthritis is an autoimmune disease that results in a chronic, systemic inflammatory disorder that may affect many tissues and organs, mainly flexible (synovial) joints. It can be a disabling and painful condition, which can lead to substantial loss of functioning and mobility, if not adequately treated.

The process involves an inflammatory response of the capsule around the joints (synovium) secondary to swelling (turgescence) of synovial cells, excess synovial fluid, and the development of fibrous tissue (pannus) in the synovium. The pathology of the disease process often leads to the destruction of articular cartilage and ankylosis (fusion) of the joints.

Onset is uncommon under the age of 15 and from then on the incidence rises with age until the age of 80. Women are affected three to five times as often as men.

 

ANKYLOSING SPONDYLITIS

Ankylosing spondylitis (AS) is a chronic inflammatory disease of the axial skeleton, with variable involvement of peripheral joints and non-articular structures. AS is a member of the group of the spondyloarthropathies, with a strong genetic predisposition. It mainly affects joints in the spine and the sacroiliac joint in the pelvis, and can cause eventual fusion of the spine. Complete fusion results in a complete rigidity of the spine, a condition known as "bamboo spine". It usually begins in the second or third decade of life and has male preponderance.

The etiology of AS is unknown, but a combination of genetic and environmental factors work together to produce the clinical disease.

The outcome in patients with AS is generally good compared to that in patients with a disease such as rheumatoid arthritis.

 

OSTEOARTHRITIS

Osteoarthritis, more commonly known as arthrosis, is the most common form of arthritis and affects millions of people around the world. Often called wear-and-tear arthritis, osteoarthritis occurs when the protective cartilage on the ends of bones wears down over time.

While osteoarthritis can damage any joint in the human body, the disorder most commonly affects joints in the hands, neck, lower back, knees and hips.

Osteoarthritis gradually worsens with time, and no cure exists. However, osteoarthritis treatments can slow the progression of the disease, relieve pain and improve joint function.

 
PRODUCTS
Brexin

Brexin (Piroxicam β-cyclodextrin) is a non-steroidal anti-inflammatory drug indicated for the symptomatic treatment of painful and inflammatory conditions in patients suffering from rheumatoid arthritis, ankylosing spondylitis and osteoarthritis, with a once-daily posology.

 

CARDIOVASCULAR DISEASES

Cardiovascular diseases (CVD) are the number one cause of death globally: more people die annually from CVDs than from any other cause.

CVD refers to any disease that affects the cardiovascular system, principally cardiac disease, vascular diseases of the brain and kidney, and peripheral arterial disease. The causes of CVD are diverse, but atherosclerosis and/or hypertension are the most common. In addition, as the ageing causes physiological and morphological changes that alter cardiovascular function and lead to an increased risk of CVD, even in healthy asymptomatic individuals.

In the fight for the prevention of CVDs, the strongest effort focusses on the treatment of hypertension, as it is one of the biggest cardiovascular risk factors. As a matter of fact, it substantially increases the probability of cardio-, cerebral- , and reno-vascular adverse events. Moreover, the possible association with other prominent risk factors, such as hypercholesterolemia, smoking and diabetes, brings about a further significant increase in probability. Therefore, the therapeutic choice must be based on individual global cardiovascular risk calculation, considering age, gender, past occurrence of cardiovascular events and presence of other associated risk factors.

 

PRODUCTS
Iperten

Iperten (Manidipine hydrochloride), a long-lasting calcium-channel blocker, is indicated for the treatment of mild-to-moderate hypertensive patients. Its vasodilatory activity is capable of reducing both systolic and diastolic blood pressure, by means of a once-daily posology.

Vivace

Vivace is the fixed combination of two antihypertensive agents, manidipine (a calcium-channel blocker) and delapril (an ACE-inhibitor), whose mechanism of action is to inhibit the formation of Angiotensin II, one of the strongest vasoconstrictor mediators. Its indication is the treatment of essential hypertension in patients not adequately controlled with manidipine or delapril monotherapy, with a once-daily posology.