PARMA, ITALY--(Marketwired - May 20, 2017) -

• Chiesi is the first pharmaceutical company to have demonstrated with randomized clinical trials, two of which published in The Lancet ^1,2, the efficacy of the triple extrafine combination to prevent exacerbations, improve symptoms and quality of life.
• Trimbow is the first fixed triple combination as extrafine formulation in a single inhaler that can improve adherence to the therapy.
• CHMP positive opinion is based on data obtained in 12 clinical studies involving more than 7,000 patients.

Chiesi Group (Chiesi), an international research-focused healthcare company, announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for the extrafine triple combination ICS/LABA/LAMA, under the brand name Trimbow^®, for the first time in a single inhaler for the treatment of Chronic Obstructive Pulmonary Disease (COPD).

Trimbow is a combination of Inhaled Corticosteroid (ICS) / Long-acting β2-agonist (LABA) / long-acting muscarinic antagonist (LAMA) that contains Beclometasone dipropionate (BDP), Formoterol fumarate (FF) and Glycopyrronium bromide (GB).

Paolo Chiesi, Chiesi Group Vice President and Head of R&D, said, "Today's positive opinion is an important step forward to make our extrafine Triple combination available to COPD patients. COPD affects millions of people across Europe, and Chiesi is committed to developing new therapeutic options that could help these patients' adherence to the therapy, thus reducing the risk of exacerbations and improving their quality of life. With this goal in mind, Chiesi has also developed the first fixed dose ICS/LABA/LAMA Triple combination."

Patients with COPD have unmet therapeutic needs, such as reducing the risk of exacerbations that impair the quality of life, which may lead to hospitalization or even be life-threatening ^3-6. Indeed, the quality of life⁷ worsens when symptoms, such as dyspnoea and cough, are not controlled, and the patient needs to be hospitalized. Moreover, COPD is a disease that deteriorates with time⁸ and therapy often needs to be progressively intensified. This requires patients to be treated with many drugs that, to date, have to be taken through two or even three inhalers. The possibility of taking all drugs needed, and reaching both central and peripheral airways through only one inhaler considerably simplifies the treatment of COPD patients, decreasing the burden on patients and, thus, improving adherence.^9,10

Therefore, a simplified treatment option based on ICS/LABA/LAMA that is able to improve lung function and reduce the risk of exacerbations in COPD patients, uncontrolled by previous therapies, would definitely satisfy those unmet needs.

The CHMP recommendation is based on the efficacy and safety data of 12 clinical studies involving more than 7,000 patients. Two of the studies were recently published by The Lancet -- one of the most prestigious international medical journals:

• TRILOGY1 is the study published in the special ERS edition of The Lancet and presented at the 2016 ERS Congress in London. The study provided for the first time, one year evidence that the extrafine fixed ICS/LABA/LAMA triple combination developed by Chiesi is superior to the fixed dose ICS/LABA combined therapy (one of the standard treatments for this condition) regarding a series of clinical parameters including exacerbations, and demonstrates a high safety profile.
• TRINITY2, published in the online April 3 issue, is the study that has demonstrated for the first time the superiority of the extrafine ICS/LABA/LAMA triple fixed dose combination therapy, developed by Chiesi, compared to the LAMA tiotropium, one of the standard treatments for COPD, on a series of efficacy parameters including exacerbations.

The CHMP positive opinion is one of the final steps before the European Commission grants marketing authorization. A final decision by the European Commission and official grant of the marketing authorization is expected during the third quarter of 2017.

About COPD

COPD is a respiratory disease characterized by a persistent bronchial obstruction, associated with an increased chronic inflammatory response of the airways to noxious particles or gas. The classic symptoms associated with COPD are dyspnoea, chronic cough and chronic productive sputum. In some cases, an acute worsening of the above-mentioned symptoms may occur, triggering an 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 significant airflow reduction throughout the lungs.

About Trimbow

Trimbow is the first extrafine fixed triple combination of Inhaled Corticosteroid (ICS) / Long-acting β2-agonist (LABA) / long-acting muscarinic antagonist (LAMA) that contains Beclometasone dipropionate (BDP), Formoterol fumarate (FF) and Glycopyrronium bromide (GB) Trimbow will be available as twice a day pMDI (pressurized metered dose inhaler) to be licensed for COPD indication, with an approved indication for maintenance treatment of COPD patients.

About Chiesi Group

Based in Parma, Italy, Chiesi Farmaceutici is an international research-focused Healthcare Group, with over 80 years of experience in the pharmaceutical industry, present in 26 countries. Chiesi researches, develops and markets innovative drugs in the respiratory therapeutics, specialist medicine and rare disease areas. Its R&D organization is headquartered in Parma (Italy), and integrated with 6 other key R&D groups in France, the USA, the UK, Sweden and Denmark to advance Chiesi's pre-clinical, clinical and registration programmes. Chiesi employs nearly 5,000 people. For more information please visit www.chiesi.com.

References

¹ Singh D, Papi A, Corradi M, Montagna I, Francisco C, Cohuet G, Vezzoli S, Scuri M, and Vestbo J. Single inhaler triple therapy versus inhaled corticosteroid plus long-acting β2 agonist for chronic obstructive pulmonary disease (TRILOGY): a double-blind, parallel group, randomised controlled trial. Accepted (2016) THELANCET-D-16-04974R1;S0140-6736(16)31354-X.

² Vestbo J, Papi A, Corradi M, Blazhko V, Montagna I, Francisco C, et al. Single inhaler extrafine triple therapy versus long-acting muscarinic antagonist therapy for chronic obstructive pulmonary disease (TRINITY): a double-blind, parallel group, randomised controlled trial. www.thelancet.com Published online April 3, 2017 http://dx.doi.org/10.1016/S0140-6736(17)30567-6.

³ Celli BR et al., An official American Thoracic Society/European Respiratory Society statement: research questions in COPD. Eur Respir J. 2015;45:879-905.

⁴ Progetto Libra 2010, Road Map BPCO, Rinite e Asma. www.goldcopd.it

⁵ Gard Italy: Sorveglianza nell'ambito delle patologie respiratorie, 25 giugno 2015.

⁶ Groenewegen KH, Schols AM, Wouters EF. Mortality and mortality-related factors after hospitalization for acute exacerbation of COPD. Chest. 2003;124:459-67.

⁷ Hernandez P, Balter M, Bourbeau J, Hodder R. Living with chronic obstructive pulmonary disease: A survey of patients' knowledge and attitudes. Respiratory Medicine. 2009;103:1004-12.

⁸ Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease, Progetto Mondiale BPCO, aggiornamento 2016 (www.goldcopd.org).

⁹ Stoloff SW, Stempel DA, Meyer J, et al. Improved refill persistence with fluticasone propionate and salmeterol in a single inhaler compared with other controller therapies. J Allergy Clin Immunol. 2004;113:245-51.

¹⁰ Nelson HS. Combination therapy of long-acting beta agonists and inhaled corticosteroids in the management of chronic asthma. Curr Allergy Asthma Rep. 2005;5:123-9.