Sosei Heptares notes Enerzair approval in Japan – the world’s first approval of this novel LABA/LAMA/ICS combination for treating bronchial asthma

• Announcement by Novartis Pharma K. K. highlights key milestone for once-daily Enerzair (IND/GLY/MF) complete with new sensor-enabled Breezhaler device
• Sosei Heptares to receive a milestone payment from Novartis
• IND/GLY/MF recently recommended for approval in the European Union and is under regulatory review in other countries

Tokyo, Japan and London, UK, 29 June 2020 – Sosei Group Corporation (“the Company”; TSE: 4565) notes that Novartis Pharma K.K., the Japan business of strategic alliance partner Novartis, announced today the world’s first manufacturing and marketing approval for its Enerzair Inhalation Capsules (medium-dose and high-dose) in Japan as a treatment of bronchial asthma  (in cases requiring combination use of inhaled corticosteroid, inhaled long-acting β2-adrenergic agonist and inhaled long-acting anticholinergic agent). The achievement of this milestone will result in a payment to Sosei Heptares from Novartis under the terms of the 2005 Development and Licensing agreement.

Enerzair, which contains the long-acting beta₂-agonist (LABA) indacaterol acetate, the long-acting muscarinic antagonist (LAMA) glycopyrronium bromide and the inhaled corticosteroid (ICS) mometasone furoate (IND/GLY/MF), is a LABA/LAMA/ICS combination and delivers its bronchodilating and anti-inflammatory action through treatment once per day with the Breezhaler inhaler. The two medium-dose and high-dose specifications each contain 150 μg of indacaterol acetate and 50 μg of glycopyrronium bromide, with 80 μg and 160 μg respectively of mometasone furoate.

For the first time in Japan, a new digital device combining a sensor with the Breezhaler inhaler is being made available.  The sensor connects with a smartphone to record   daily treatment doses and provide medication reminders. It also enables communication between patients and their physicians, contributing to the long-term management of insufficiently controlled asthma.

The full announcement in Japanese from Novartis Pharma K.K. is available at https://www.novartis.co.jp/news.

High-dose IND/GLY/MF received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in April 2020. Additional regulatory reviews are currently underway in multiple countries, including Switzerland and Canada.

Shinichi Tamura, President and CEO of Sosei Heptares, commented: “I would like to congratulate Novartis for achieving this important milestone with Enerzair. The addition of this new product and the new digital device combining a sensor with the Breezhaler inhaler provides a new option for the treatment and long-term management of under-controlled asthma. We look forward to the final decision by the European Commission in the near future and further updates in relation to filings in other countries over the coming year.”

About Uncontrolled Asthma

Asthma affects an estimated 358 million people worldwide, including approximately 8 million people in Japan, and can cause a significant personal, health and financial burden when not adequately controlled^1,2,3. 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 uncontrolled^4,5. Patients with uncontrolled asthma may downplay or underestimate the severity of their disease and are at a higher risk of exacerbation, hospitalization or death^6,7,8. Barriers, such as treatment mismatch, safety issues with an oral corticosteroid and ineligibility for biologics, have created an unmet medical need in asthma^9,10.

References

1.       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. Available at: https://doi.org/10.1016/S2213-2600(17)30293-X. Last accessed June 2020.

2.       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 June 2020.

3.       Ministry of Health, Labour and Welfare Science Research “Research on epidemiological surveys and epidemiological database creation required for countermeasures against allergic diseases (President Akira Akazawa) 2016 report”

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

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

7.       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.

8.       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.

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

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

About Sosei Heptares

We are an international biopharmaceutical group focused on the discovery and early development of new medicines originating from our proprietary GPCR-targeted StaR technology and structure-based drug design platform capabilities. We are advancing a broad and deep pipeline of novel medicines across multiple therapeutic areas, including CNS, immuno-oncology, gastroenterology, inflammation and other rare/specialty indications.

We have established partnerships with some of the world’s leading pharmaceutical companies, including AbbVie, AstraZeneca, Genentech (Roche), Novartis, Pfizer and Takeda, and additionally with multiple emerging biotechnology companies. Sosei Heptares is headquartered in Tokyo, Japan with R&D facilities in Cambridge, UK.

“Sosei Heptares” is the corporate brand and trademark of Sosei Group Corporation, which is listed on the Tokyo Stock Exchange (ticker: 4565). Sosei, Heptares, the logo and StaR are trademarks of Sosei Group companies.

For more information, please visit https://www.soseiheptares.com/

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