Patients With COPD May Soon Benefit From the Chiesi Farmaceutici's Investigation Into a Fixed Triple Combination ICS/LABA/LAMA

PARMA, ITALY--(Marketwired - June 07, 2016) -

• Chiesi is the first Company to complete 2 multicenter long-term clinical studies with a fixed triple combination for COPD
• The preliminary results of the two 12-month studies appears positive
• Chiesi is also the first company to develop a triple combination with three active ingredients delivered by a single inhaler

Chiesi Farmaceutici SpA (Chiesi) announces today the completion of two multicenter clinical studies with its fixed ICS/LABA/LAMA triple combination investigational product, CHF 5993, for Chronic Obstructive Pulmonary Disease (COPD). COPD is a progressive disease obstructing both large and small airways, causing patients to have a considerably impaired pulmonary function, poor quality of life and risk to exacerbate. Patients with moderate and severe COPD are particularly prone to exacerbations and the frequency of these exacerbations increases with the severity of the disease.

Chiesi's fixed triple combination contains three active ingredients, the anti-inflammatory inhaled corticosteroid beclomethasone (ICS), and two bronchodilators, the long-acting beta₂ agonist formoterol (LABA) and the long-acting muscarinic antagonist glycopyrronium (LAMA), in one single inhaler.

Two pivotal, active control studies, run in parallel for 12 months and involving more than 4000 patients, are already concluded. "This is the first time that we have seen an effect of triple therapy on exacerbations," commented Dave Singh, Professor of Clinical Pharmacology and Respiratory Medicine at Manchester University and Principal Investigator of one of the studies. "These studies show a consistent effect of the fixed triple therapy combination on a range of outcomes including exacerbations, lung function and quality of life."

Paolo Chiesi, Vice President and Head of Research and Development of Chiesi, emphasizes:

"As regards to the regulatory schedule, we are on track with the plan that foresees the filing [in the EU] by IV quarter of the current year."

About Chiesi Farmaceutici

Headquartered in Parma, Italy Chiesi Farmaceutici is an international research-focused Healthcare group, with over 80 years of experience in the pharmaceutical industry. Chiesi researches, develops and markets innovative drugs in the respiratory therapeutics, specialist medicine and rare diseases areas. Its R&D centres in Parma (Italy), Paris (France), Cary (USA), Chippenham (UK) and the R&D team of the acquired Danish company Zymenex, integrate their efforts to advance Chiesi's pre-clinical, clinical and registration programs. Chiesi employs over 4,500 people, 560 of whom are solely dedicated to Research and Development activities. www.chiesi.com

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 dyspnea, 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.

About CHF 5993

CHF 5993 is an investigational fixed triple combination that contains three active ingredients. CHF 5993 is seeking regulatory approval in the European Union and is not currently approved. The safety and efficacy profile have not been fully established or reviewed by the European Medicines Agency or the US Food and Drug Administration.