Press release
Sep 8, 2014

Positive results from three clinical trials presented at ERS 2014 further confirmed efficacy of Ultibro® Breezhaler® and Seebri® Breezhaler®, and promotion agreement with Pfizer in the UK


  • LANTERN study further confirmed superiority of Ultibro® Breezhaler® in improving lung function compared to Seretide® Accuhaler®* in moderate-to-severe COPD patients1 
  • QUANTIFY study showed superiority of Ultibro® Breezhaler® in lung function and shortness of breath versus tiotropium plus formoterol2 
  • New data from GLISTEN study will provide important evidence for the benefits of once-daily Seebri® Breezhaler® as add on therapy to LABA/ICS**
  • Novartis has signed an exclusive promotion agreement for Ultibro® Breezhaler® and Seebri® Breezhaler® in the United Kingdom with Pfizer Limited.
 
Tokyo, Japan – 8 September 2014: Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565) confirms the new data from three clinical trials presented by Novartis at the European Respiratory Society (ERS) International Congress, September 6-10, in Munich, Germany.
 
The LANTERN study demonstrated that once-daily Ultibro® Breezhaler® (indacaterol/glycopyrronium bromide) was superior in reducing exacerbations (flare ups) and improving lung function compared to twice-daily Seretide® Accuhaler®* (salmeterol/fluticasone (SFC)), in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). The study showed Ultibro® Breezhaler® significantly reduced the rate of moderate-to-severe exacerbations by 31% compared to SFC1, in moderate-to-severe COPD patients with a history of one exacerbation or none in the previous year. In addition, Ultibro® Breezhaler® patients had significantly increased lung function (trough FEV1 0.075 L (p<0.001); AUC0-4h 0.122 L (p<0.001)), as compared to SFC after 26 weeks of treatment. The safety profile of Ultibro® Breezhaler® was comparable to SFC1.
 
The new findings from LANTERN support the use of Ultibro® Breezhaler® as an alternative steroid-free treatment to SFC in moderate-to-severe COPD patients1. This approach is consistent with the Global Initiative for Chronic Obstructive Lung Disease 2014 guidelines3.
 
Analyses from the QUANTIFY study demonstrated that Ultibro® Breezhaler® significantly improved lung function and shortness of breath in patients with moderate-to-severe COPD, compared to the combination of tiotropium plus formoterol2. Results also showed that Ultibro® Breezhaler® is comparable to tiotropium plus formoterol in improving health related quality of life2.
 
Data from the GLISTEN trial showed that Seebri® Breezhaler® (glycopyrronium bromide) when added to LABA/ICS provided significant improvements in lung function, health status and rescue medication use in moderate-to-severe COPD patients when compared to LABA/ICS alone3. This study provides much-needed evidence for add-on therapy to LABA/ICS in COPD, to support physicians care choices where very little data exist4.
 
The safety profiles of Ultibro® Breezhaler® and Seebri® Breezhaler® were similar to those of their respective study comparators in the LANTERN, QUANTIFY and GLISTEN studies1,2,3.
 
COPD symptoms can have a major negative impact on a patient’s ability to breathe and function, reducing their quality of life4,5. Essential daily activities such as climbing stairs can become very difficult as the condition gradually worsens6. There is a need for newer treatment options in COPD because many patients remain symptomatic despite medical therapy7.
 
Furthermore, Novartis Pharmaceuticals UK Ltd has announced that it had signed an exclusive promotion agreement for Ultibro® Breezhaler® and Seebri® Breezhaler® in the United Kingdom with Pfizer Limited (“Pfizer”). Under the terms of this agreement, Pfizer will assume sole responsibility for commercial activities relating to Ultibro® Breezhaler® and Seebri® Breezhaler® in the UK, while Novartis will continue to be responsible for the manufacture, sale and distribution of both medicines, in addition to regulatory, pharmacovigilance and medical information commitments.
 
It is estimated that there are three million people living with the COPD in the UK17. The UK market is estimated to be the second largest globally in terms of COPD market value18.
 
 

References
1. Zhong N et al. Efficacy and safety of once-daily QVA149 compared with twice-daily salmeterol/fluticasone combination (SFC) in patients with COPD: the LANTERN study. [ERS abstract 700090; Session 281; Date: September 8 2014 Time: 12:50-14:40].
2. Korn S et al. Once-daily QVA149 improves lung function and dyspnoea compared with tiotropium plus formoterol: the QUANTIFY study [ERS abstract 850533; Session 101; Date: September 7, 2014 Time: 12:50-14:40].
3. Frith P et al. Glycopyrronium once-daily significantly improves lung function and health status when added to fluticasone/salmeterol in patients with COPD: The GLISTEN study. [ERS abstract 700128; Session 281; September 8, 2014 Time: 12:50-14:40].
4. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Updated 2014. http://www.goldcopd.org/uploads/users/files/GOLD_Report2014_Feb07.pdf [Accessed 23 July 2014].
5. Joshi M, Joshi A, Bartter T. Symptom burden in chronic obstructive pulmonary disease and cancer. Curr Opin Pulm Med 2012;18:97-103.
6. World Health Organization. Chronic Obstructive Pulmonary Disease Factsheet No. 315, Available at: http://www.who.int/mediacentre/factsheets/fs315/en/. [Accessed 5 August 2014].
7. Hersh CP. Pharmacogenetics of chronic obstructive pulmonary disease: challenges and opportunities. Pharmacogenomics 2010;11(2):237-247. Clinicaltrials.gov. A 26-week treatment randomized, double-blind, double dummy study to assess the efficacy and safety of QVA149 (LANTERN). NCT01709903. http://clinicaltrials.gov/ct2/show/NCT01709903 [Accessed 23 July 2014].
8. Clinicaltrials.gov. A 26-week treatment randomized, double-blind, double dummy study to assess the efficacy and safety of QVA149 (LANTERN). NCT01709903. http://clinicaltrials.gov/ct2/show/NCT01709903 [Accessed 23 July 2014].
9. Ultibro Breezhaler EU Summary of Product Characteristics. [Online] 3 October 2013. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Product_Information/human/002679/WC500151255.pdf [Accessed 23 July 2014].
10. Vogelmeier C et al. Once-daily QVA149 provides clinically meaningful improvements in lung function and clinical outcomes versus placebo, indacaterol, glycopyrronium, tiotropium and salmeterol/fluticasone in patients with COPD. [ATS abstract 40759; Session C45; Date: May 21, 2013 Time: 8:15 -10:45].
11. Vogelmeier C et al. Once-daily QVA149 provides clinically meaningful improvements in lung function and clinical outcomes. [ERS 2013 abstract 851178; Session 82; Date: September 8, 2013 Time: 12:50-14:40].
12. Banerji D et al. Dual bronchodilation with once-daily QVA149 improves dyspnea and health status and reduces symptoms and rescue medication use in patients with COPD: the IGNITE trials. [ERS 2013 abstract 851388; Session 346; Date: September 10, 2013 Time: 8:30-10:30].
13. 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_Manual/en/. [Accessed 23 July 2014].
14. 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.
15. 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 23 July 2014].
16. Seretide® Summary of Product Characteristics [Online] Available at: https://www.medicines.org.uk/emc/medicine/2317/SPC/Seretide+100,+250,+500+Accuhaler [Accessed 1 August 2014]
17. NHS Choices. Chronic Obstructive Pulmonary Disease. Available at: http://www.nhs.uk/conditions/chronicobstructive-pulmonary-disease/Pages/Introduction.aspx. Visited 21 August 2014.
18. IMS PADDS Qtrly, Medical March 2014. COPD Only Indication: ICD10 – J42, J43, J44.
 
 
 
 
 
 

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