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 controlled1,2,3. 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 uncontrolled4,5. Patients with uncontrolled asthma may downplay or underestimate the severity of their disease and are at a higher risk of exacerbation, hospitalization or death6,7,8. Barriers, such as treatment mismatch, safety issues with an oral corticosteroid and ineligibility for biologics, have created an unmet medical need in asthma9,10.
Enerzair® and Breezhaler® are registered trademarks of Novartis AG.
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