Novartis receives approval in the European Union for Onbrez Breezhaler, a new once-daily bronchodilator for patients with COPD

- Onbrez Breezhaler demonstrated superiority to tiotropium[1], formoterol[2], salmeterol[3];
- first new inhaled compound for treatment of COPD in seven years for EU patients
- Onbrez Breezhaler is only treatment for COPD to combine 24-hour bronchodilation[1,2,3] from a once-daily dose with rapid onset of action within five minutes[4,5]
- COPD affects 210 million people globally[6], up to 82 million in Europe[7,8], and is projected to become the third leading cause of death worldwide[9]

Basel, December 3, 2009 - Novartis announced today that the European Commission (EC) has approved Onbrez Breezhaler (QAB149 or indacaterol) in both 150 mcg and 300 mcg doses as a new once-daily maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD).
 
"Onbrez Breezhaler has demonstrated greater improvements in lung function, breathlessness and quality of life compared to current therapies," said Joe Jimenez, CEO of the Novartis Pharmaceuticals Division. "The EC approval of Onbrez Breezhaler means this new and effective therapy will soon be available to people in the EU with COPD and, through better symptom control, will help them to live more active and productive lives despite their condition."
 
Onbrez Breezhaler, containing the active ingredient indacaterol maleate, is the first new inhaled compound for the treatment of COPD to be made available for EU patients in seven years. Additionally, it is the first and only treatment to demonstrate in clinical studies both 24-hour bronchodilation[1,2,3] and a rapid onset of action within five minutes of inhalation[4,5].
 
COPD is a progressive, life-threatening respiratory disease[10] that affects 210 million people worldwide[6], up to 82 million in Europe[7,8], the majority of whom are under the age of 65[11]. COPD impairs lung function resulting in chronic breathlessness. This leads to a profound, negative impact on patients' ability to work and support families. COPD currently ranks tenth in overall disease burden, ahead of asthma and diabetes[12].
 
The EC based its approval of Onbrez Breezhaler on data from over 6,000 patients. This data included pivotal Phase III results showing Onbrez Breezhaler significantly improved lung function[1] and provided clinically relevant improvement in symptoms of breathlessness compared to tiotropium[13]. Recent data presented at the American College of Chest Physicians (ACCP) Chest Conference showed once-daily Onbrez Breezhaler also achieved significant improvements in lung function compared to twice-daily salmeterol, another current treatment option[3]. In addition, Onbrez Breezhaler provided better health status* and improved breathlessness compared with salmeterol[3].
 
Onbrez Breezhaler has shown good overall safety and tolerability, which is comparable to other current treatments[3,14,15]. The most common adverse drug reactions were nasopharyngitis, cough, upper respiratory tract infection, and headache[16]. These were in the vast majority mild or moderate and became less frequent as treatment was continued[16].
 
QAB149 was filed with the United States Food and Drug Administration (FDA) in late 2008. In October 2009, Novartis received a Complete Response letter from the US. The FDA requested additional information on the dosing proposed, which Novartis is working to address.
 
Improving the management of COPD is a priority focus for Novartis and Onbrez Breezhaler is the lead compound in an expected once-daily portfolio for the treatment of this growing public health issue. Novartis has three additional investigational treatments in its late-stage COPD portfolio, NVA237, QVA149 and QMF149. Novartis is also exploring new pathways in the treatment of COPD as part of an innovative, early-stage pipeline with disease modifying potential.
 

About COPD

COPD is commonly caused by cigarette smoke and other harmful fumes, and is characterized by a persistent obstruction of airflow in the lungs, resulting in breathlessness[10]. COPD is currently projected to become the third leading cause of death worldwide by 2020[9]. Bronchodilators are a group of drugs that widen the airways in the lungs and are considered the cornerstone of COPD treatment, relieving symptoms and preventing exacerbations. While incurable, COPD is manageable, and improving airflow with the use of long-acting bronchodilators is central to symptomatic relief[17]. 
 
*For this study, health status was assessed using St. George's Respiratory Questionnaire, a standardized self-completed questionnaire for measuring impaired health and perceived well-being.