Press release
Sep 7, 2020

Sosei Heptares notes presentation of post hoc analysis showing high-dose Enerzair® Breezhaler® reduces asthma exacerbations versus medium-dose, complementing key pivotal IRIDIUM study findings


•       Analysis presented at the European Respiratory Society (ERS) Virtual International Congress 2020

 

Tokyo, Japan and London, UK, 7 September 2020 – Sosei Group Corporation (“the Company”; TSE: 4565) notes that its strategic alliance partner Novartis announced today that high-dose, once-daily Enerzair® Breezhaler® (indacaterol acetate, glycopyrronium bromide and mometasone furoate [IND/GLY/MF]) significantly reduces both moderate-to-severe and severe asthma exacerbation rates in patients whose asthma is uncontrolled  on medium- or high-dose LABA/ICS*, when compared with a once-daily medium-dose of the same treatment.

The post hoc analysis – presented at the European Respiratory Society (ERS) Virtual International Congress 2020 – showed high-dose Enerzair® Breezhaler® (150/50/160 μg) significantly reduced the annualized rate of moderate-to-severe asthma exacerbations by 21% (p=0.026) and severe exacerbations by 31% (p=0.003) in asthma patients not adequately controlled on current inhaled therapies, compared with medium-dose (150/50/80 μg) over 52 weeks1.

High-dose Enerzair® Breezhaler® also reduced the annualized rate of all exacerbations (mild, moderate and severe) by 14% (p=0.132) compared with medium-dose, but this finding was not statistically significant. Both doses tested presented with a favorable safety and tolerability profile.

The post hoc analysis complements findings from Novartis’ pivotal Phase III IRIDIUM study, recently published in The Lancet Respiratory Medicine2. The data also showed the safety profile for high-dose Enerzair® Breezhaler® was in line with previous studies in the Phase III/IIIb PLATINUM clinical development program.

Enerzair® Breezhaler®, which includes an optional digital companion (sensor and app) is the first LABA/LAMA/ICS fixed-dose combination approved for patients whose asthma is uncontrolled with a LABA/ICS3. The product is approved in the European Union, Japan and Canada. Further regulatory reviews are currently underway in other countries.

The full announcement from Novartis is available at www.novartis.com.

Glycopyrronium bromide and certain intellectual property relating to its use and formulation were exclusively licensed to Novartis in April 2005 by Sosei Heptares and Vectura Group Plc. Novartis is responsible for the development and commercialization of Enerzair® Breezhaler® (QVM149). Under the agreement, Sosei Heptares is entitled to certain development milestones and royalties on net sales upon successful commercialization of Enerzair® Breezhaler®.

Shinichi Tamura, President and CEO of Sosei Heptares, commented: “A significant proportion of asthma patients do not achieve optimal symptom control on existing therapies. These latest findings from a post-hoc analysis of the IRIDIUM study not only support the use of high-dose Enerzair® Breezhaler® to significantly improve lung function and reduce exacerbations relative to standard of care LABA/ICS, but also its potential as a step-up treatment option in patients with uncontrolled asthma.”

*Abbreviations used: LABA – long acting beta2-agonist (e.g. IND); LAMA – long-acting muscarinic antagonist (e.g. GLY); ICS - inhaled corticosteroid (e.g. MF)

 

About Uncontrolled Asthma

Asthma affects an estimated 358 million people worldwide and can cause a significant personal, health and financial burden when not adequately controlled4,5. Despite current therapy, over 40% of patients with asthma at Global Initiative for Asthma (GINA) Step 3, and over 45% at GINA Steps 4 and 5 remain uncontrolled6,7. Patients with uncontrolled asthma may downplay or underestimate the severity of their disease and are at a higher risk of exacerbation, hospitalization or death8-10. Barriers, such as less than optimal adherence, incorrect inhaler technique, treatment mismatch, safety issues with oral corticosteroids and ineligibility for biologics, have created an unmet medical need in asthma11-14.

 

References

  1. Chapman KR, Kostikas K, Kerstjens H, et al. Reduction in asthma exacerbations with indacaterol/ glycopyrronium/ mometasone high-dose versus medium-dose: a post hoc analysis from the IRIDIUM study. e-Poster presented at the European Respiratory Society (ERS) Virtual Congress; 2020 Sept 7–9.
  2. Kerstjens HAM, Maspero J, Chapman KR, et al. Once-daily, single-inhaler mometasone-indacaterol-glycopyrronium-mometasone versus indacaterol-mometasone or twice-daily fluticasone-salmeterol in patients with inadequately controlled asthma (IRIDIUM): a randomised, double-blind, controlled Phase III study. Lancet Resp Med 2020. doi: 10.1016/S2213-2600(20)30190-9.
  3. European Medicines Agency. Enerzair Breezhaler. Available from: https://www.ema.europa.eu/en/medicines/human/summaries-opinion/enerzair-breezhaler [Last accessed: August 2020].
  4. GBD Chronic Respiratory Disease Collaborators. Global, regional, and national deaths, prevalence, disability-adjusted life years, and years lived with disability for chronic obstructive pulmonary disease and asthma, 1990–2-15: a systematic analysis for the Global Burden of Disease Study 2015. Lancet Resp Med 2017;5(9):691–706.
  5. Asthma and Allergy Foundation of America. My Life With Asthma Survey Overview. Available from: https://www.aafa.org/media/1684/my-life-with-asthma-in-2017-survey-findings-report.pdf [Last accessed: August 2020].
  6. Chung KF, Wenzel SE, Brozek JL, et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J 2014;43(2):343–373.
  7. Fang J, Busse WW, Marvel J, et al. Demographic, Clinical Characteristics and Control Status of Pediatric, Adolescent, and Adult Asthma Patients by GINA Step in a US Longitudinal Cohort. Am J Resp Crit Care Med 2018;197:A1903.
  8. Peters SP, Ferguson G, Deniz Y, Reisner C. Uncontrolled asthma: a review of the prevalence, disease burden and options for treatment. Respir Med 2006;100(7):1139–1151.
  9. Katsaounou P, Odemyr M, Spranger O, et al. Still Fighting for Breath: a patient survey of the challenges and impact of severe asthma. ERJ Open Res 2018;4(4):00076–2018.
  10. Price D, Fletcher M, van der Molen T. Asthma control and management in 8,000 European patients: the REcognise Asthma and LInk to Symptoms and Experience (REALISE) survey. NPJ Prim Care Respir Med 2014;24:14009.
  11. Price DB, Trudo F, Voorham J, et al. Adverse outcomes from initiation of systemic corticosteroids for asthma: long-term observational study. J Asthma Allergy 2018;11:193–204.
  12. Albers FC, Müllerová H, Gunsoy NB, et al. Biologic treatment eligibility for real-world patients with severe asthma: The IDEAL study. J Asthma 2018;55(2):152–160.
  13. Bourdin A, Halimi L, Vachier I, et al. Adherence in Severe Asthma. Clin Exp Allergy 2012;42(11):1566–1574.
  14. Global Initiative for Asthma (GINA). 2020 GINA Pocket guide for asthma management and prevention. Available from: https://ginasthma.org/wp-content/uploads/2020/04/Main-pocket-guide_2020_04_03-final-wms.pdf [Last accessed: August 2020].

 

Enerzair® and Breezhaler® are registered trademarks of Novartis AG.

 

– ENDS –

 


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