Enerzair® Breezhaler® is a fixed dose, once daily combination of the long-acting muscarinic antagonist (LAMA) glycopyrronium bromide, the long-acting beta agonist (LABA) indacaterol, and the inhaled corticosteroid (ICS) mometasone furoate.
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 (LSE: VEC). Novartis is responsible for the development and commercialization of Enerzair® Breezhaler®. Under the agreement, Sosei Heptares is entitled to certain development milestones, and royalties on net sales upon successful commercialisation of Enerzair® Breezhaler®.
Enerzair® Breezhaler® is currently being registered in multiple key territories worldwide as a maintenance treatment of uncontrolled asthma in adult patients by Novartis.
Asthma affects an estimated 358 million people worldwide and can cause a significant personal, health and financial burden when not adequately controlled. 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. Patients with uncontrolled asthma may downplay or underestimate the severity of their disease and are at a higher risk of exacerbation, hospitalization or death. Barriers, such as treatment mismatch, safety issues with an oral corticosteroid and ineligibility for biologics, have created an unmet medical need in asthma.
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