Novartis showcases 39 abstracts highlighting robust respiratory portfolio at ERS 2013

New data to be presented from the Novartis respiratory portfolio at the European Respiratory Society (ERS) Annual Congress 2013 in Barcelona, Spain, further demonstrates Novartis’ commitment to providing treatment options for patients with chronic obstructive pulmonary disease (COPD) or severe allergic asthma (SAA).

“Patients with COPD or severe allergic asthma, and the healthcare professionals that treat them, need effective treatment choices. Novartis is committed to providing a broad range of options to help reduce the significant burden of respiratory disease”, commented Tim Wright, Head of Development, Novartis Pharmaceuticals. “Novartis is very excited to be sharing important new data at ERS to further demonstrate the strength of our expanding respiratory portfolio and continued commitment to this therapeutic area.”

Data presented at ERS include the latest analyses from the Phase III IGNITE clinical trial program on Ultibro® Breezhaler® (QVA149 – indacaterol 85 mcg/glycopyrronium 43 mcg delivered dose, equivalent to 110 mcg/50 mcg metered dose per capsule)[1],[2],[3]. QVA149 is a once-daily investigational fixed dose combination of a long-acting beta2-adrenergic agonist (LABA) and a long-acting muscarinic antagonist (LAMA), that received a positive opinion for approval from the European Medicine Agency’s (EMA) Committee for the Human use of Medicinal Products (CHMP) in July 2013 as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD.

New exacerbation, lung function and safety data will also be presented on Seebri® Breezhaler® (glycopyrronium 44 mcg delivered dose equivalent to 50 mcg metered dose per capsule)[4],[5], and efficacy data on Onbrez® Breezhaler® (indacaterol maleate 150 mcg)[7], which are the monotherapy components of QVA149.

In severe allergic asthma, new data will be presented on Xolair® (omalizumab), an anti-IgE monoclonal antibody indicated as an add-on therapy for patients with uncontrolled severe allergic (IgE-mediated) asthma. It is well recognized that omalizumab can significantly reduce the risk of exacerbations in patients with severe allergic asthma and new studies are helping to better understand its effects on the processes that underlie the disease.

New clinical data relating to investigational QGE031 will be presented for the first time at ERS. QGE031 is a humanized anti-Immunoglobulin E monoclonal antibody in development for the treatment of IgE-driven diseases where a significant unmet need exists such as severe uncontrolled asthma, atopic dermatitis (AD) and food allergies[6].

Alongside abstract presentations, Novartis will also be holding the following three symposia at ERS:

• Rethinking the treatment landscape of COPD: September 8 (17:15-19:15 CET, Room 3.13)
• The omalizumab story: Past, present and future: September 8 (17:15-19:15 CET, Room 3.12)
• Dual bronchodilation: A new treatment option for COPD patients: September 9 (17:15-19:15 CET, Room 3.13.

ERS is the largest respiratory meeting in the world, with delegates attending from more than 100 countries. All abstracts and details on timings can be accessed through the ERS website: http://www.erscongress2013.org.

About the Novartis respiratory portfolio

Novartis is committed to addressing the unmet medical needs of patients with respiratory diseases and improving their quality of life by providing innovative medicines and devices. In addition, the company is currently conducting more than 145 sponsor-led clinical trials involving more than 140,000 patients in support of regulatory submissions for new respiratory medicines. Novartis is consistently rated as having one of the industry’s most respected pharmaceutical development pipelines with more than 140 projects in pharmaceutical clinical development.

Onbrez® Breezhaler® (indacaterol maleate) is a long-acting beta2-adrenergic agonist (LABA) that offers clinically relevant 24-hour bronchodilation combined with a rapid onset of action within five minutes at first dose, as demonstrated in the INERGIZE Phase III trial program[10]-[24]. Onbrez Breezhaler 150 mcg once-daily provided greater clinical benefit in terms of reduced shortness of breath, lower use of rescue medication and improved health status, compared with blinded tiotropium bromide 18 mcg in patients with moderate-to-severe COPD[21]. Onbrez Breezhaleris approved in approximately 100 countries around the world for maintenance bronchodilator treatment of airflow obstruction in adult patients with COPD[25]. It was first launched in the EU (150 mcg and 300 mcg once-daily doses) and has since received approvals in markets worldwide including Japan (Onbrez® Inhalation Capsules 150 mcg once-daily) and US (ArcaptaTM NeohalerTM 75 mcg once-daily).

Once-daily Seebri® Breezhaler® (glycopyrronium bromide) is a novel inhaled long-acting muscarinic antagonist (LAMA; also referred to as a long-acting anticholinergic) indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD[26]. Glycopyrronium bromide was exclusively licensed to Novartis in April 2005 by Vectura and its co-development partner Sosei. Phase III data from the GLOW 1, 2 and 3 studies demonstrated that glycopyrronium 50 mcg delivered rapid and significant sustained improvements in lung function (measured by mean FEV1) from Day 1 compared with placebo and sustained this for 24 hours over 52 weeks, and significantly improved exercise endurance versus placebo[27],[28],[29]. Seebri Breezhaler is approved in the EU/EEA, Japan, Switzerland, Canada, Australia and a number of other countries.

QVA149 is an investigational inhaled, once-daily, fixed-dose combination of indacaterol maleate and glycopyrronium bromide. QVA149 is being investigated for the treatment of COPD in the Phase III IGNITE clinical trial program. IGNITE is one of the largest international clinical trial programs in COPD comprising 11 studies in total (ILLUMINATE, SHINE, BRIGHT, ENLIGHTEN, SPARK, BLAZE, ARISE, BEACON, RADIATE, LANTERN, FLAME) with more than 10,000* patients across 52 countries[30]-[42]. The first eight studies (ILLUMINATE, SHINE, BRIGHT, ENLIGHTEN, SPARK, BLAZE, ARISE, BEACON) completed in 2012. The studies are designed to investigate efficacy, safety and tolerability, lung function, exercise endurance, exacerbations, shortness of breath and quality of life of patients treated with QVA149.

Results from the Phase III IGNITE trials[30]-[38],[42] demonstrated statistically significant improvements in bronchodilation with QVA149 versus certain treatments widely used as current standards of care[43]. Data showed that QVA149 significantly improved bronchodilation compared to open-label (OL) tiotropium 18 mcg, salmeterol/fluticasone fixed dose combination (SFC) 50 mcg/500 mcg, indacaterol maleate 150 mcg, glycopyrronium 50 mcg and placebo providing a rapid onset within five minutes, and sustained bronchodilation during a 24 hour period which was maintained for up to 26 weeks. In the IGNITE phase III trial program, QVA149 also showed symptomatic improvements versus placebo in COPD patients[31],[33],[34],[43]. These symptomatic improvements included breathlessness, exercise tolerance, rescue medication use and health-related quality of life[31],[33],[34],[43].

In clinical studies, QVA149 demonstrated an acceptable safety profile with no meaningful differences between the treatment groups (placebo, indacaterol 150 mcg, glycopyrronium 50 mcg, OL tiotropium 18 mcg, SFC 50 mcg/500 mcg) in the incidence of adverse and serious adverse events[30],[31],[33],[34],[44].

Novartis continues development of respiratory products for delivery via a platform called the Breezhaler® device. This is a single-dose dry powder inhaler (SDDPI), which has low air flow resistance, making it suitable for patients with different severity of airflow limitation[45]. The Breezhaler® device allows patients to hear, feel and see that they have taken the full dose correctly[26].

In 2003, the US Food and Drug Administration (FDA) approved Xolair® (omalizumab), an injectable therapy, for the treatment of patients 12 years of age and older with moderate-to-severe persistent allergic asthma that is inadequately controlled with inhaled corticosteroids[46]. In 2005, the Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion on the marketing authorization for Xolair for the treatment of severe persistent allergic asthma in adults and adolescents (>=12 years of age)[47], who have multiple severe asthma exacerbations despite daily high dose inhaled corticosteroids plus a long acting beta agonist. This was followed by the European Commission granting marketing authorization for all 25 EU member states[47]. In 2009, Novartis also received marketing approval for Xolair in the EU as an add on therapy to high dose inhaled corticosteroid (ICS) plus a LABA, to treat children aged 6 to <12 years with severe persistent allergic asthma[48].

Xolair is a humanized monoclonal antibody that blocks the action of immunoglobulin E (IgE), an antibody involved in the underlying mechanism of allergic asthma. In three pivotal trials[49],[50],[51]involving 482, 525 and 546 patients respectively, by targeting IgE, Xolair was shown to significantly decrease the incidence of asthma exacerbations in severely affected patients when added to an ICS and LABA[49],[50],[51]. Novartis co-promotes Xolair with Genentech/Roche in the US and shares a portion of the operating income, but does not book US sales.

*Total refers to all 11 IGNITE studies.

About COPD

COPD is a progressive life-threatening disease that makes it hard to breathe, with symptoms that have a destructive impact on patients’ function and quality of life[52],[53]. It affects an estimated 210 million people worldwide[54] and is projected to be the third leading cause of death by 2020[52]. COPD is often considered to be a disease of later years, but estimates suggest that 50% of those with COPD are now less than 65 years old, resulting in increases in absenteeism, premature retirement and reductions in workforce participation[55].

About severe allergic asthma

Asthma is a chronic, inflammatory lung disease that is often triggered by allergies. Asthma is characterized by airway obstruction, resulting in the symptoms of chest tightness, wheezing and coughing[56].

Asthma affects around 300 million people globally[57] and is one of the most common chronic diseases among children[58]. For an estimated 5-8% of patients, symptoms are more severe[59]. A proportion of asthmatic patients have their symptoms triggered when exposed to everyday allergens such as dust and mould – these patients have allergic asthma[57],[59].

References

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