Novartis announced positive results from two pivotal Phase III clinical trial programs for QVA149 and NVA237 in patients with COPD

  • QVA149 improved lung function, breathlessness and health-related quality of life in moderate-to-severe COPD patients, according to EXPEDITION trial results[1]-[7]
  • GEM 1 & 2 studies showed NVA237 provided significant and clinically meaningful improvements in lung function in moderate-to-severe COPD patients[8],[9]
  • In total, 26 Novartis abstracts presented at American Thoracic Society (ATS) 2015; showcasing breadth of respiratory portfolio

BASEL, 21-5-2015 — /EuropaWire/ — Novartis announced today positive results from two pivotal Phase III clinical trial programs for QVA149 (indacaterol/glycopyrronium bromide) and NVA237 (glycopyrronium bromide) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). The EXPEDITION (including FLIGHT 1, 2 and 3 studies) and GEM programs met their primary and secondary endpoints, and the results were presented for the first time at the ATS International Conference, May 15-20, 2015, in Denver, US[1]-[9].

Data from the EXPEDITION program demonstrated that QVA149, administered twice-daily, improved lung function (FEV1 AUC0-12h) compared to placebo and its individual monocomponents, indacaterol and glycopyrronium bromide (p<0.001), after 12 weeks of treatment, meeting its primary objective[1]-[2]. Further findings also confirmed that Novartis’ dual bronchodilator improved breathlessness, overall quality of life and COPD rescue medication use[1]-[4]. It also showed significant improvements in FEV1at 5 min and 15 min compared to placebo according to new pooled data from over 2,000 patients[5].

“These data confirm that QVA149 significantly improves lung function, breathlessness, and most importantly, overall quality of life”, said Vasant Narasimhan, Global Head of Development, Novartis Pharmaceuticals. “With millions of people in the US and around the world struggling to breathe due to COPD, Novartis is committed to advancing QVA149 and other new medicines to address this important unmet need”.

In the GEM 1 and 2 studies, NVA237, administered twice-daily, demonstrated significant and clinically meaningful improvements in lung function (FEV1 AUC0-12h) at week 12 in moderate-to-severe COPD patients compared to placebo (p<0.001); meeting its primary objective[8],[9]. Improvements in COPD symptoms, quality of life and rescue medication use in patients with moderate-to-severe airflow limitation were also observed[8],[9].

The safety profiles of QVA149, its monotherapy components and placebo were broadly similar across the EXPEDITION studies[6],[7], as was NVA237 to indacaterol and placebo in the GEM studies[8],[9].

There is an urgent need for new COPD treatments in the US as many people remain symptomatic despite receiving medical care[10]. Reflecting this, evidence from the EXPEDITION and GEM programs presented today has also been used to support current QVA149 and NVA237 US regulatory submissions.

About EXPEDITION
The EXPEDITION program consisted of trials, including FLIGHT 1 and 2, which were identical 12-week, multi-center, randomized, double-blind, parallel-group, placebo-and active-controlled studies to assess the efficacy, safety, and tolerability of QVA149 (indacaterol/glycopyrronium bromide) in moderate-to-severe COPD patients. The primary objective was to compare QVA149 27.5/12.5 mcg, administered twice-daily, to its monotherapy components in terms of lung function (FEV1 AUC0-12h) at week 12[1]-[4]. Breathlessness was measured by the transition dyspnea index (TDI) total score and overall quality of life by the St George’s Respiratory Questionnaire (SGRQ) total score.FLIGHT 3 was a 52-week randomized, double-blind, parallel-group study to assess the safety and tolerability of QVA149 27.5/12.5 mcg, administered twice-daily, compared to once-daily indacaterol 75 mcg in moderate-to-severe COPD patients. The primary endpoint was the overall rate of adverse events reported during the study[7].

About GEM
GEM 1 and 2 were 12-week multi-center, randomized, double-blind, placebo-controlled studies to assess the efficacy and safety of NVA237 (glycopyrronium bromide) 12.5 mcg, administered twice-daily, in moderate-to-severe COPD patients. The primary objective was to compare NVA237 to placebo in terms of lung function (FEV1 AUC0-12h) after 12 weeks of treatment[8],[9].

About QVA149
QVA149 (indacaterol/glycopyrronium bromide) 27.5/12.5 mcg, administered twice daily, as used in the EXPEDITION program, has been submitted for US registration. Outside of the US, QVA149 is marketed as Ultibro® Breezhaler® 110/50 mcg, which is a once-daily maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD11. Once-daily Ultibro Breezhaler is currently approved for use in over 60 countries, including countries within the EU and Latin America, Japan, Canada, Switzerland and Australia.

About NVA237
NVA237 (glycopyrronium bromide) 12.5 mcg, administered twice-daily, as used in the GEM trials, has been submitted for US registration. Outside of the US, NVA237 is marketed as Seebri® Breezhaler® 50 mcg, which is a once-daily medication indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD. Once-daily Seebri Breezhaler is approved for use in over 80 countries, including countries within the EU and Latin America, Japan, Canada, Switzerland and Australia[12].

About the Novartis COPD portfolio
Novartis is committed to addressing the unmet medical needs of COPD patients and improving their quality of life by providing innovative medicines and devices. The Novartis COPD portfolio includes QVA149/Ultibro Breezhaler (indacaterol/glycopyrronium bromide), NVA237/Seebri Breezhaler (glycopyrronium bromide) and Onbrez® Breezhaler®/Arcapta®Neohaler® (indacaterol inhalation powder), which are all indicated as maintenance treatments for COPD patients. Glycopyrronium bromide was exclusively licensed to Novartis in April 2005 by Vectura and its co-development partner Sosei.

Worldwide, Novartis continues development of respiratory products for delivery via the low resistance Breezhaler® inhalation device, which makes it suitable for patients with different severities of airflow limitation[13]. The Breezhaler device allows patients to hear, feel and see that they have taken the full dose correctly[11],[13].

About COPD
COPD affects an estimated 210 million people worldwide[14] and nearly 27 million in the United States (US)[15]. It is a progressive lung condition associated with chronic morbidity and mortality[14]. Deaths from COPD are projected to increase over the next 10 years by more than 30% unless underlying risk factors are addressed[16]. COPD is the third leading cause of death in America, claiming the lives of 134,676 Americans in 2010[17], and is expected to be the third leading cause of death worldwide by 2030[16].

COPD makes it difficult to breathe, with symptoms that have a destructive impact on patients’ ability to function and their quality of life[14],[18]. It 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[19],[20].

Disclaimer
The foregoing release contains forward-looking statements that can be identified by words such as “committed,” “continues,” “projected,” “expected,” or similar terms, or by express or implied discussions regarding potential marketing approvals for QVA149 and NVA237, or regarding potential future revenues from QVA149, NVA237 and the other products in the Novartis COPD portfolio. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that QVA149 or NVA237 will be approved for sale in any markets where they have been submitted, or will be submitted or approved for sale in any additional markets, or at any particular time. Nor can there be any guarantee that QVA149, NVA237 and the other products in the Novartis COPD portfolio will be commercially successful in the future. In particular, management’s expectations regarding QVA149, NVA237 and the other products in the Novartis COPD portfolio could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; the company’s ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; unexpected manufacturing issues, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. 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 and cost-saving generic pharmaceuticals. Novartis is the only global company with leading positions in these areas. In 2014, the Group achieved net sales of USD 58.0 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 120,000 full-time-equivalent associates and sell products in more than 150 countries around the world. For more information, please visit http://www.novartis.com.

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References

[1] Kerwin EM, Fowler Taylor A, Ayers T et al. QVA149 improves lung function to a greater extent than monocomponents in patients with poderate-to-severe COPD: The FLIGHT 1 Study. [ATS abstract 62856; Session D36; Date: Wednesday, May 20, 2015; 9:30am – 3:30pm].
[2] Kerwin EM, Ayers T, Fowler Taylor A et al. QVA149 provides superior improvement in lung function versus its monocomponents in patients with moderate-to-severe COPD: the FLIGHT 2 study [ATS abstract 62690; Session D36; Date: Wednesday, May 20, 2015; 9:30am – 3:30pm].
[3] Jones P, Mahler D, Fowler Taylor A, Ayers T et al. QVA149 show superior improvements in quality of life, as measured by SGRQ, compared with placebo in patients with moderate-to-severe COPD: the FLIGHT 2 study. [ATS abstract 62846; Session D36; Date: Wednesday, May 20, 2015; 9:30am – 3:30pm].
[4] Mahler D, Fowler Taylor A, Ayers T et al. QVA149 reduces dyspnea in patients with moderate-to-severe COPD as measured by the transition dyspnea index: the FLIGHT 2 study [ATS abstract 61730; Session D36; Date: Wednesday, May 20, 2015; 9:30am – 3:30pm].
[5] Banerji D, Fowler Taylor A, Ayers T et al. QVA149 shows rapid onset of bronchodilation versus placebo and its mono-components in patients with moderate-to-severe COPD: pooled data from the FLIGHT studies. [ATS abstract 62677; Session D36; Date: Wednesday, May 20, 2015; 9:30am – 3:30pm].
[6] Fowler Taylor A, Ayers T, Thach C et al. Safety of QVA149 versus its monocomponents and placebo: a pooled safety analysis from FLIGHT 1 and FLIGHT 2 studies. [ATS abstract 63617; Session D36; Date: Wednesday, May 20, 2015; 9:30am – 3:30pm].
[7] Ferguson G, Fowler Taylor A, Ayers T et al. QVA149 is safe and well tolerated in patients with moderate-to-severe COPD: FLIGHT 3, a 52-week safety study. [ATS abstract 63609; Session D36; Date: Wednesday, May 20, 2015; 9:30am – 3:30pm].
[8] LaForce C, Pearle J, Feldman G, et al. efficacy and safety of glycopyrronium in COPD patients with moderate-to-severe airflow limitation: The GEM 1 Study. [ATS abstract 62680; Session D36; Date: Wednesday, May 20, 2015; 9:30am – 3:30pm].
[9] Kerwin EM, Siler TM, Korenblat PE et al. Glycopyrronium twice daily improves lung function and quality of life and is well tolerated in COPD patients with moderate-to-severe airflow limitation: The GEM 2 Study. [ATS abstract 63673; Session D36; Date: Wednesday, May 20, 2015; 9:30am – 3:30pm].
[10] Price D, West D, Brusselle G, et al. Management of COPD in the UK primary-care setting: an analysis of real-life Prescribing Patterns. International Journal of COPD. 2014;9:889-905.
[11] EMA (2015) Ultibro Breezhaler EU Summary of Product Characteristics. [Online] Revised 27 January 2015. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_- Product_Information/human/002679/WC500151255.pdf[Accessed 16 March 2015].
[12] EMA (2014). Seebri Breezhaler EU Summary of Product Characteristics. [Online] Revised 28 September 2012. Available at: https://www.medicines.org.uk/emc/medicine/27138/SPC/Seebri+Breezhaler+Inhalation+Powder,+Hard+Capsules+44mcg/%20[Accessed 13 April 2015].
[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] Global Alliance Against Chronic Respiratory Diseases (GARD). 8th General Meeting. Available at: http://www.who.int/gard/publications/GARDGMreport2013.pdf. [Accessed 16 March 2015].
[15] NIH NHLIB Chartbook 2012. Available at: https://www.nhlbi.nih.gov/files/docs/research/2012_ChartBook_508.pdf [Last accessed 21 April 2015]
[16] World Health Organization: Chronic Obstructive Pulmonary Disease (COPD) Fact Sheet. Available at: http://www.who.int/respiratory/copd/burden/en/. [Accessed 16 March 2015]
[17] National Vital Statistics Report (NVSR): Deaths: Final Data for 2012. Available at: http://www.cdc.gov/nchs/data/nvsr/nvsr63/nvsr63_09.pdf [Accessed 16 March 2015].
[18] Joshi M, Joshi A, Bartter T. Symptom burden in chronic obstructive pulmonary disease and cancer. Curr Opin Pulm Med2012;18:97-103.
[19] DaCosta M et al. The burden of chronic obstructive pulmonary disease among employed adults. Int J Chron Obstruct Pulmon Dis 2012;7:211-219. Published online 2012 March 19. doi: 10.2147/COPD.S29280. [Accessed 16 March 2015].
[20] 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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