Sosei Group Announces Positive Results for Ultibro® and Seebri® Presented at ERS 2014, 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**3
  • Novartis has signed an exclusive promotion agreement for Ultibro® Breezhaler® and Seebri® Breezhaler® in the United Kingdom with Pfizer Limited.

TOKYO--()--Sosei Group Corporation (“Sosei”)(TOKYO: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.

About LANTERN

LANTERN was a randomized, double-blind, parallel-group, 26-week study involving 744 patients and conducted at 56 sites across China, Argentina, Chile and Taiwan8. The primary objective of the study was to demonstrate the non-inferiority of Ultibro® Breezhaler® 110/50 mcg to SFC 50/500 mcg in terms of lung function (trough FEV1) after 26 weeks of treatment in stable patients with moderate-to-severe COPD, with a history of one exacerbation or none in the previous year1. Ultibro® Breezhaler® demonstrated non-inferiority and additionally showed superior efficacy versus SFC for the primary objective. In this study, exacerbations were a pre-specified exploratory endpoint.

About QUANTIFY

QUANTIFY was a 26-week treatment, multicenter, randomized, parallel group, blinded study to assess the efficacy and safety of once-daily Ultibro® Breezhaler® in 934 patients with moderate-to-severe COPD, versus the free-combination of tiotropium 18 mcg plus formoterol 12 mcg. The primary objective of QUANTIFY was to demonstrate non-inferiority of Ultibro® Breezhaler® in HRQoL, as assessed by the St. George’s Respiratory Questionnaire-COPD (SGRQ-C), versus tiotropium plus formoterol after 26 weeks of treatment in patients with moderate-to-severe COPD2. Secondary endpoints included transition dyspnea index (TDI) score, trough FEV1, forced vital capacity (FVC) and safety and tolerability2.

About GLISTEN

The primary objective of GLISTEN was to demonstrate non-inferiority of Seebri® Breezhaler® 50 mcg versus tiotropium 18 mcg when added to salmeterol/fluticasone 50/500 mcg on trough FEV1 after 12 weeks of treatment in patients with moderate-to-severe COPD3. The secondary endpoints included comparison of Seebri® Breezhaler® 50mcg added to salmeterol/fluticasone compared with salmeterol/fluticasone plus placebo3.

About Ultibro® Breezhaler®

Once-daily Ultibro® Breezhaler® (EU)/ Ultibro® Inhalation Capsules (Japan) is a novel, once-daily dual bronchodilator approved as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD9. Ultibro® Breezhaler® is a fixed-dose combination of the long acting muscarinic antagonist (LAMA), glycopyrronium bromide (brand name: Seebri® Breezhaler®) and the long acting beta2-agonist (LABA), indacaterol maleate, and was developed by Novartis under development code QVA149. Clinical trials have shown that Ultibro® Breezhaler® offers statistically significant improvements in bronchodilation compared to treatments widely used as current standards of care, including salmeterol/fluticasone 500/50 mcg and open-label tiotropium 18 mcg10-12. Ultibro® Breezhaler® is currently approved for use in over 40 countries, including countries within the EU, Japan, countries within Latin America and Australia.

About Seebri® Breezhaler®

Once-daily Seebri® Breezhaler® (EU)/ Seebri® Inhalation Capsules 50 mcg (Japan), (NVA237, glycopyrronium bromide), is a novel inhaled long-acting muscarinic antagonist (LAMA) indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD. Seebri® Breezhaler® has been approved as a maintenance bronchodilator treatment for COPD in over 70 countries across Europe, Japan, Canada, Australia, South America, Middle East and Asia. In addition, Novartis is conducting Phase III trial for Seebri® Breezhaler® in asthma patients.

Glycopyrronium bromide was exclusively licensed to Novartis in April 2005 by Sosei and its co-development partner Vectura.

Ultibro®, Seebri® and Breezhaler® are registered trademarks of Novartis AG.

About COPD

COPD affects an estimated 210 million people worldwide13 and is projected to be the third leading cause of death by 20204. It is progressive (usually gets worse over time), and can be a life-threatening disease4,13. COPD makes it difficult to breathe, with symptoms that have a destructive impact on patients’ function (i.e. activity limitation, decreased mobility) and quality of life4,13. 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 participation14,15.

About Sosei

Sosei is an international biopharmaceutical company anchored in Japan with a global reach. It practises a reduced risk business model by acquiring compounds from, and bringing compounds into, Japan through exploitation of its unique position within global markets.

For further information about Sosei, please visit www.sosei.com.

*The LANTERN study used Seretide® (salmeterol/fluticasone) 50/500 mcg, which is indicated in the UK for the symptomatic treatment of patients with COPD, with a FEV1 <60% predicted normal (prebronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy16. The patient population in the LANTERN study were stable moderate-to-severe COPD patients with a history of one exacerbation or none in the previous year. Seretide® is also known as Advair®, and Accuhaler® is also known as Diskus®. Seretide®, Advair®, Diskus® and Accuhaler® are registered trademarks of the GlaxoSmithKline group of companies.

**LABA (long-acting beta agonist); ICS (inhaled corticosteroid)

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/chronic-obstructive-pulmonary-disease/Pages/Introduction.aspx. Visited 21 August 2014.
  18. IMS PADDS Qtrly, Medical March 2014. COPD Only Indication: ICD10 – J42, J43, J44

Forward-looking statements

This press release contains forward-looking statements, including statements about the discovery, development and commercialisation of products. Various risks may cause Sosei’s actual results to differ materially from those expressed or implied by the forward-looking statements, including: adverse results in clinical development programmes; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialise products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialisation activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts

Sosei Group Corporation
Tokyo Office
Milica STOJKOVIC, +81-(0)3-5210-3399
Investor Relations
mstojkovic@sosei.com
or
London Office
Kathryn LYDON, +44-(0)20-7691-0983
PA to CEO & Corporate Communication
klydon@sosei.com

Contacts

Sosei Group Corporation
Tokyo Office
Milica STOJKOVIC, +81-(0)3-5210-3399
Investor Relations
mstojkovic@sosei.com
or
London Office
Kathryn LYDON, +44-(0)20-7691-0983
PA to CEO & Corporate Communication
klydon@sosei.com