Novartis once-daily QVA149 shows superior efficacy in reducing exacerbations, improving lung function and quality of life in COPD patients

New York, 23/04/2013 (informazione.it - comunicati stampa - salute e benessere)

• SPARK results published in Lancet Respiratory Medicine showed that dual bronchodilator QVA149 significantly reduced the rate of moderate or severe COPD exacerbations compared to glycopyrronium 50 mcg
• QVA149 significantly reduced the rate of all COPD exacerbations compared to open-label tiotropium 18 mcg and glycopyrronium
• QVA149 also demonstrated significant improvements in lung function and health-related quality of life

Basel, April 23, 2013 - Results from the 64-week SPARK study published today in Lancet Respiratory Medicine showed that investigational once-daily dual bronchodilator QVA149 (indacaterol maleate 110 mcg / glycopyrronium 50 mcg) was more effective at reducing all chronic obstructive pulmonary disease (COPD) exacerbations compared to glycopyrronium 50 mcg and open-label (OL) tiotropium 18 mcg[1] a treatment with established efficacy in preventing exacerbations[2],[3],[4],[5]. This is the first study to evaluate the effect on exacerbations of dual bronchodilation with a fixed-dose combination of a long-acting beta₂-agonist (LABA) and a long-acting muscarinic antagonist (LAMA), versus single LAMA therapies.

 

"We are delighted that results from SPARK demonstrated that QVA149 reduced the overall rate of exacerbations in patients with severe and very severe COPD. For physicians and their patients, these findings offer hope of a new effective treatment to prevent debilitating COPD exacerbations and improve health-related quality of life," said Tim Wright, Global Head of Development at Novartis Pharma AG.

 

SPARK was a 64-week, multi-center, double-blind, parallel-group, active controlled study with the primary objective to show superiority of QVA149 (indacaterol maleate 110 mcg / glycopyrronium 50 mcg) versus glycopyrronium 50 mcg for the rate of moderate to severe COPD exacerbations in 2,224 patients with severe to very severe COPD. The key secondary objective was to show superiority of QVA149 compared with OL tiotropium 18 mcg with respect to the rate of moderate or severe COPD exacerbations during the treatment period. Patients aged >=40 years with >=1 COPD exacerbation in the year before were randomized to receive either once-daily QVA149, glycopyrronium or OL tiotropium 18 mcg[1].

 

The study met its primary endpoint demonstrating that QVA149 significantly reduced the rate of moderate or severe COPD exacerbations by 12% versus glycopyrronium (p=0.038). The rate of moderate or severe exacerbations was numerically lower (p=0.096) in patients on QVA149 compared to OL tiotropium 18 mcg. The rate of all (mild, moderate, and severe) exacerbations was significantly reduced by 15% with QVA149 compared to glycopyrronium (p=0.0012) and by 14% compared with OL tiotropium 18 mcg (p=0.0017). All treatments had an acceptable safety profile, and there was no meaningful difference between the treatment groups in the incidence of adverse and serious adverse event reporting[1]. Novartis has previously released the First Interpretable Results (FIR) for SPARK.

 

SPARK also demonstrated that the dual bronchodilator effect of QVA149 resulted in substantially improved lung function. During the 64-week study, results showed that lung function, as measured by trough FEV₁ was significantly higher with QVA149 compared to glycopyrronium (p<0.0001) and OL tiotropium 18 mcg (p<0.0001) at each assessment during the treatment period.

 

Additionally, QVA149 showed significant differences in health-related quality of life during the study as demonstrated by lower St George&apos;s Respiratory Questionnaire (SGRQ) total scores of QVA149 versus glycopyrronium (p<0.01), and OL tiotropium 18 mcg (p<0.05). Percentages of patients achieving the minimum clinically important (>=4 unit) improvement in SGRQ total scores were higher with QVA149 compared to glycopyrronium (p=0.055) or OL tiotropium 18 mcg (p=0.051), even up to Week 64[1].  

 

The effective management of COPD exacerbations is very important to both patients and physicians, as exacerbations can impose a significant burden of morbidity, mortality, reduced quality of life and increased healthcare costs[6],[7]. Frequent exacerbations are linked to an accelerated decline in lung function[8],[9]and patients are also known to have a poorer quality of life[10]. Admissions to hospital due to exacerbations are increasing[11] and patients with more severe underlying disease account for around 70% of the direct medical costs of COPD[12].

 

Novartis is committed to addressing the unmet medical needs of COPD patients and improving their quality of life by providing innovative medicines and devices. SPARK is one of 10 studies investigating QVA149 for the treatment of COPD in the IGNITE Phase III clinical trial program, which involves more than 7,000 patients across 42 countries.

 

About the Novartis COPD portfolio

Onbrez^® Breezhaler^® (indacaterol maleate) is a 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. Onbrez Breezhaler 150 mcg QD provided greater clinical benefit in terms of reduced shortness of breath, lower use of rescue medication and improved health status, compared with blinded tiotropium 18 mcg. Onbrez Breezhaleris approved in more than 100 countries around the world. 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 (Arcapta^TM Neohaler^TM 75 mcg once-daily).

 

Once-daily Seebri^® Breezhaler^® (glycopyrronium bromide) is a novel inhaled LAMA (also referred to as a long-acting anticholinergic) so far approved in EU, Japan, Canada, Australia and other countries as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD. Glycopyrronium 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 the morning on Day 1 compared with placebo and sustained this for 24 hours over 52 weeks, and significantly improved exercise endurance versus placebo.

 

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 10 studies in total* (ILLUMINATE, SHINE, BRIGHT, ENLIGHTEN, SPARK, BLAZE, ARISE, BEACON, RADIATE, LANTERN) with more than 7,000 patients across 42 countries. The first eight studies (ILLUMINATE, SHINE, BRIGHT, ENLIGHTEN, SPARK, BLAZE**, ARISE**, BEACON) have already 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.

 

*Total refers to all 10 IGNITE studies.

**BLAZE & ARISE were not included within the Q4 2012 filings to the EU and Japan.

 

Novartis continues development of respiratory products for delivery via the Breezhaler^® device. This is a single-dose dry powder inhaler (SDDPI), which has low air flow resistance, making it suitable for patients with airflow limitation[13]. The Breezhaler^® device allows patients to hear, feel and see that they have taken the full dose correctly[14].

 

About COPD

COPD is a progressive life-threatening disease that makes it hard to breathe, with symptoms that have a destructive impact on patients&apos; function and quality of life. It affects an estimated 210 million people worldwide[15] and is projected to be the third leading cause of death by 2020[16]. 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[17].

 

Disclaimer

The foregoing release contains forward-looking statements that can be identified by terminology such as "hope," "committed," "being investigated," "projected," or similar expressions, or by express or implied discussions regarding potential marketing approvals for QVA149 or regarding potential future revenues from QVA149. You should not place undue reliance on these statements.  Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with QVA149 to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that QVA149 will be submitted or approved for sale in any market. Nor can there be any guarantee that QVA149 will achieve any particular levels of revenue in the future. In particular, management&apos;s expectations regarding QVA149 could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; competition in general; government, industry and general public pricing pressures; unexpected manufacturing issues; the company&apos;s ability to obtain or maintain patent or other proprietary intellectual property protection; the impact that the foregoing factors could have on the values attributed to the Novartis Group&apos;s assets and liabilities as recorded in the Group&apos;s consolidated balance sheet, and other risks and factors referred to in Novartis AG&apos;s current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

 

About Novartis

Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2012, the Group achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 128,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.

 

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References:

[1] Wedzicha JA, Decramer M, Ficker JH, et al. Analysis of Chronic Obstructive Pulmonary Disease Exacerbations with the Dual Bronchodilator QVA149 Compared with Glycopyrronium and Tiotropium (SPARK): a Randomized, Double-blind, Parallel-group Study. Lancet Respir Med 2013 http://www.thelancet.com/journals/lanres/onlinefirst Accessed 23 April 2013
[2] Niewoehner DE, Rice K, Cote C, et al. Prevention of exacerbations of chronic obstructive pulmonary disease with tiotropium, a once-daily inhaled anticholinergic bronchodilator: a randomized trial. Ann Intern Med 2005; 143: 317-26.
[3] Wedzicha JA, Calverley PM, Seemungal TA, et al, for the INSPIRE Investigators. The prevention of chronic obstructive pulmonary disease exacerbations by salmeterol/fluticasone propionate or tiotropium bromide. Am J Respir Crit Care Med 2008; 177: 19-26.
[4] Vogelmeier C, Hederer B, Glaab T, et al. Tiotropium versus salmeterol for the prevention of exacerbations of COPD. N Engl J Med 2011; 364: 1093-103.
[5] Tashkin DP, Celli B, Senn S, et al, for the UPLIFT Study Investigators. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med 2008; 359: 1543-54.
[6] Simoens S et al. Clinical and economic analysis of antimicrobial therapy of chronic obstructive pulmonary disease exacerbations. Int J Clin Pract. 2007; 61: 200-206.
[7] Hurst J et al. Chronic obstructive pulmonary disease: the clinical management of an acute exacerbation. Postgrad Med J. 2004; 80: 497-505.
[8] Kanner RE, Anthonisen NR, Connett JE; Lung Health Study Research Group. Lower respiratory illnesses promote FEV(1) decline in current smokers but not ex-smokers with mild chronic obstructive pulmonary disease: results from the lung health study. Am J Respir Crit Care Med 2001; 164:358-64
[9] Donaldson GC, Seemungal TA, Bhowmik A, Wedzicha JA. Relationship between exacerbation frequency and lung function decline in chronic obstructive pulmonary disease. Thorax 2002; 57:847-52.
[10] Seemungal TA, Donaldson GC, Paul EA, et al. Effect of exacerbation on quality of life in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med 1998; 157: 1418-22.
[11] Lung and Asthma Information Agency. Trends in hospital admissions for lung disease. Fact sheet 2001/4. London: St George&apos;s Hospital Medical School.
[12] Sullivan SD, Ramsey SD, Lee TA: The economic burden of COPD. Chest 2000;117(suppl 2):5S-9S.
[13] Pavkov et al. Characteristics of a capsule based dry powder inhaler for the delivery of indacaterol. CMRO 2010; 26; 11:2527-2533. doi:10.1185/03007995.2010.518916.
[14] SPC: EMA. 2012. Seebri Breezhaler EU Summary of Product Characteristics. [Online] 17 October 2012. Last accessed 6 February 2013.
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Product_Information/human/002430/WC500133769.pdf
[15] Global Alliance Against Chronic Respiratory Diseases (GARD). Global surveillance, prevention and control of chronic respiratory diseases: a comprehensive approach. Available at: http://www.who.int/gard/publications/GARD%20Book%202007.pdf. Last accessed 18 April 2013.
[16] Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. Updated 2011. http://www.goldcopd.org/guidelines-global-strategy-for-diagnosis-management.html. Last accessed 14 April 2013.
[17] Fletcher MJ 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. 

 

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