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Press Release

Novartis QVA149 Phase III COPD studies meet primary endpoints

Posted on: 02 Apr 12

- QVA149 efficacy, safety and exercise endurance primary endpoints all met[1],[2],[3]

- Studies are part of IGNITE Phase III clinical trial program intended to form the basis for an NDA filing in COPD

- QVA149, a bronchodilator with dual mode of action, is Novartis' third innovation in its Breezhaler® Single Dose Dry Powder Inhaler

- COPD is predicted to be the third leading cause of death in the world by 2020[4]

The first three Novartis QVA149 Phase III studies in the treatment of chronic obstructive pulmonary disease (COPD) all met their primary endpoints. The SHINE, BRIGHT and ENLIGHTEN studies, which are key components of the IGNITE program, demonstrate the potential of QVA149 in the treatment of COPD.

The results of SHINE, with an enrollment of more than 2,100 patients, met the primary endpoint by demonstrating the superiority in trough FEV1 (p

The results of BRIGHT demonstrated that patients experienced significantly better exercise endurance versus placebo (p=0.006)[3]. ENLIGHTEN demonstrated that QVA149 was well tolerated with a safety and tolerability profile similar to placebo[2].

"Meeting the primary endpoints in the IGNITE Phase III clinical trial program signals significant progress in establishing the potential of QVA149, which is expected to be the third innovative medicine in our strong COPD portfolio," said Tim Wright, Head of Development, Novartis Pharmaceuticals. "Novartis is committed to addressing the unmet needs of COPD patients and improving their quality of life by providing innovative medicines and devices."

QVA149 (indacaterol 110 mcg/glycopyrronium bromide 50 mcg) is an investigational inhaled, once-daily, fixed dose combination of the long acting beta2-agonist (LABA) indacaterol, and the long-acting muscarinic antagonist (LAMA) glycopyrronium bromide (NVA237). Data from the IGNITE clinical trial program examining QVA149 in a number of settings will be submitted for presentation to a major medical congress later this year.

IGNITE is one of the largest international patient registration programs in COPD comprising 10 studies in total. The first seven studies (ENLIGHTEN, BRIGHT, SHINE, ILLUMINATE, SPARK, BLAZE, ARISE) are expected to complete in 2012 and include more than 5,700 patients across 42 countries and support planned filings in the EU and Japan. Included in the program is a head-to-head trial vs Seretide®[5] (ILLUMINATE), which is also expected to complete during the second quarter of 2012 and will be incorporated into regulatory filings. These studies are designed to investigate efficacy, safety and tolerability, lung function, exercise endurance, exacerbations, dyspnea and quality of life.

SHINE is a 26-week, multicenter, randomized, double-blind, parallel-group, placebo and active controlled pivotal trial of 2,144 patients with moderate to severe COPD to assess efficacy in terms of trough FEV1. BRIGHT is a three-week, randomized, blinded, double-dummy, multi-center, placebo controlled, three-period crossover pivotal trial of 85 patients with moderate or severe COPD to assess the effect on exercise tolerance of QVA149. ENLIGHTEN is a 52-week, multicenter, randomized, double-blind, parallel-group, placebo controlled pivotal trial of 339 patients with moderate or severe COPD to assess the safety and tolerability of QVA149.

COPD is a progressive disease associated mainly with tobacco smoking, air pollution or occupational exposure, which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness. It affects an estimated 210 million people worldwide[6] and is predicted to be the third leading cause of death by 2020[4]. Although COPD is often thought of as a disease of the elderly, 50% of patients are estimated to be within the ages of 50 and 65, which means that half of the COPD population are likely to be impacted at the peak of their earning power and family responsibilities[7].

QVA149 would be the third innovation in the Novartis COPD portfolio to be delivered using the Breezhaler® Single Dose Dry Powder Inhaler, along with Onbrez® Breezhaler® (indacaterol) and investigational Seebri® Breezhaler® (glycopyrronium bromide/NVA237).

Onbrez® Breezhaler® (indacaterol maleate) is the only COPD treatment to offer clinically relevant 24-hour bronchodilation combined with a rapid onset of action at first dose and has shown significant symptomatic improvement especially on breathlessness[8]. In March 2012, Novartis launched the 75 mcg once-daily dose in the US under the brand name Arcapta(TM) Neohaler(TM). It is also available as a 150 mcg once-daily dose in Japan under the brand name Onbrez® Inhalation Capsules.

Seebri® Breezhaler® (glycopyrronium bromide/NVA237) is an investigational long-acting muscarinic antagonist (LAMA) developed as a once-daily inhaled maintenance therapy for the treatment of COPD. Phase III data from the GLOW 1, 2 and 3 studies demonstrated that Seebri increased patients' lung function over a 24-hour period compared to placebo with a fast onset of action at first dose, as well as improving exercise endurance. Glycopyrronium bromide (Seebri® Breezhaler®) was licensed to Novartis in April 2005 by Vectura and its co-development partner Sosei, and was submitted for regulatory approval in Europe in Q3 2011 and Japan in Q4 2011.

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[1] QVA149 A2303 (SHINE). Data on file, Novartis Pharma AG. identifier: NCT01202188.

[2] QVA149 A2307 (ENLIGHTEN). Data on file, Novartis Pharma AG. identifier: NCT01120717.

[3] QVA149 2305 (BRIGHT). Data on file, Novartis Pharma AG. identifier: NCT01294787.

[4] Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. Updated 2011. Last accessed 23 March 2012.

[5] Seretide is a registered trademark of GSK

[6] Global Alliance against Chronic Respiratory Diseases (GARD). Global surveillance, prevention and control of chronic respiratory diseases: a comprehensive approach. Available at: Last accessed 23 March 2012.

[7] Fletcher, M, et al. COPD Uncovered: An International survey on the impact of chronic obstructive pulmonary disease (COPD) on a working age population. BMC Public Health 2011, 11:612.

[8] Onbrez® Breezhaler® (indacaterol)EU Summary of Product Characteristics May 31, 2011

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Last updated on: 02/04/2012

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