Sosei Heptares notes Enerzair® Breezhaler® approval in the European Union as a treatment for uncontrolled asthma

• European Commission approves once-daily Enerzair® Breezhaler® (QVM149; IND/GLY/MF) in the EU, the first-in-class LABA/LAMA/ICS fixed-dose combination for patients whose asthma is uncontrolled with LABA/ICS¹
• Optional digital companion with sensor and app that provide inhalation confirmation, medication reminders and access to objective data to better support therapeutic decisions also covered by EC approval
• Sosei Heptares to receive a milestone payment of US$5 million from Novartis and is eligible for royalties on future sales
• Enerzair® Breezhaler® is approved in Japan and is under regulatory review in multiple countries

Tokyo, Japan and London, UK, 7 July 2020 – Sosei Group Corporation (“the Company”; TSE: 4565) notes that strategic alliance partner Novartis announced today that the European Commission (EC) has approved Enerzair® Breezhaler® (QVM149; indacaterol acetate, glycopyrronium bromide and mometasone furoate [IND/GLY/MF]) as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long-acting beta₂-agonist (LABA) and a high-dose of an inhaled corticosteroid (ICS) who experienced one or more asthma exacerbations in the previous year.

Once-daily Enerzair® Breezhaler® is the first LABA/long-acting muscarinic antagonist (LAMA)/ICS fixed-dose combination available in the European Union (EU) for these patients. The approval also includes an optional digital companion with sensor and app that provides inhalation confirmation, medication reminders and access to objective data to better support therapeutic decisions.

EC approval is based on robust efficacy and safety data from over 3,000 asthma patients in Novartis’ Phase III IRIDIUM study, in which once-daily Enerzair® Breezhaler® was superior to once-daily Atectura® Breezhaler® (IND/MF) in improving the lung function of patients whose asthma is uncontrolled with LABA/ICS standard-of-care treatment².

The EC decision is applicable to all 27 European Union member states as well as the UK, Iceland, Norway and Liechtenstein.

Once-daily Enerzair® Breezhaler® has been approved in Japan and Canada, and additional regulatory reviews are currently underway in multiple countries, including Switzerland.

The achievement of this milestone results in a payment to Sosei Heptares of US$5 million from Novartis under the terms of its 2005 Development and Licensing agreement. Sosei Heptares is eligible to receive royalties from future sales of Enerzair® Breezhaler® in the EU and other markets in which it is approved.

The full announcement from Novartis, which includes further product and clinical information, is available at www.novartis.com.

Shinichi Tamura, President and CEO of Sosei Heptares, commented: “I would like to congratulate Novartis for achieving this important milestone with Enerzair® Breezhaler®. The addition of this new product and the novel digital companion provides a new option for many patients whose asthma remains uncontrolled despite existing therapies. We look forward to further updates in relation to filings and launches of this innovative new product in other countries over the coming year.”

About Uncontrolled Asthma

Asthma affects an estimated 358 million people worldwide and can cause a significant personal, health and financial burden when not adequately controlled^3,4. 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 inadequately controlled^5,6. Patients with uncontrolled asthma may downplay or underestimate the severity of their disease and are at a higher risk of exacerbation, hospitalization or death^7-9. 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 asthma^10-13.

*About Enerzair® Breezhaler® (IND/GLY/MF) in the EU

The EC approved high-dose Enerzair® Breezhaler® (IND/GLY/MF) 150/50/160 μg once-daily as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a LABA and a high-dose of an ICS who experienced one or more asthma exacerbations in the previous year¹. This formulation combines the bronchodilation of indacaterol acetate (a LABA) and glycopyrronium bromide (a LAMA) with mometasone furoate (ICS) in a precise once-daily formulation, delivered via the dose-confirming Breezhaler® device. Glycopyrronium bromide certain use and formulation intellectual property were exclusively licensed to Novartis in April 2005 by Sosei Heptares and Vectura. Mometasone furoate is exclusively licensed to Novartis from a subsidiary of Merck & Co., Inc, Kenilworth, NJ, USA, for use in IND/GLY/MF (worldwide excluding the US).

Novartis developed the optional digital companion in collaboration with Propeller Health, which includes the Propeller Health app and sensor custom-built for the Breezhaler® device.  The sensor is a CE marked Medical Device, designed and licensed to Novartis for use with the Breezhaler® inhaler worldwide. The sensor includes a microchip, a microphone, Bluetooth capabilities, an antenna and a battery. The sensor does not alter the drug delivery characteristics of the Breezhaler® inhaler itself but produces a recording of each administered dose. Based on the patient’s recorded medication usage, personalized content is presented within the app to help the patient better self-manage their asthma.

References

1 Enerzair^® Breezhaler^® (indacaterol acetate, glycopyrronium bromide and mometasone furoate [IND/GLY/MF]) SmPC.

2 Data on file

3 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. 2017;5(9)691-706.

4 AAFA. My Life With Asthma Survey Findings Report. Available at: https://www.aafa.org/media/1684/my-life-with-asthma-in-2017-survey-findings-report.pdf. Last accessed July 2020.

5 Chung KF et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J 2014;43(2):343-73.

6 Fang 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

7 Peters SP et al. Uncontrolled asthma: a review of the prevalence, disease burden and options for treatment. Respir Med 2006;100(7):1139-1151.

8 Katsaounou P 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.

9 Price D et al. 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.

10 Price D, et al. Adverse outcomes from initiation of systemic corticosteroids for asthma: long-term observational study. J Asthma Allergy 2018;11:193-204.

11 Albers FC et al. Biologic treatment eligibility for real-world patients with severe asthma: The IDEAL study. J Asthma 2018;55(2):152-160.

12 Bourdin A, Halimi L. et al. Adherence in Severe Asthma. Clin Exp Allergy 2012;42(11):1566-74.

13 Global Initiative for Asthma (GINA). Pocket guide for asthma management and prevention. Available at: https://ginasthma.org/wp-content/uploads/2019/04/GINA-2019-main-Pocket-Guide-wms.pdf Last accessed July 2020.

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