Press release
Apr 4, 2017

Availability of UTIBRON™ NEOHALER® (indacaterol/glycopyrrolate) Inhalation Powder in the United States

UTIBRON™ NEOHALER® is the latest combination therapy for people with chronic obstructive pulmonary disease (COPD) that addresses unmet patient and physician needs

Tokyo, Japan – 4 April 2017: Sosei Group Corporation (“Sosei”; TSE Mothers Index:4565) is pleased to confirm that Sunovion Pharmaceuticals Inc. (Marlborough, Mass.,) announced the availability of Utibron™ Neohaler® (indacaterol/glycopyrrolate) inhalation powder in the United States for the long-term maintenance treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. UTIBRON NEOHALER is not indicated to treat asthma or for the relief of sudden symptoms of COPD.

UTIBRON NEOHALER is a twice-daily combination long-acting beta agonist and longacting muscarinic antagonist (LABA/LAMA). Sunovion entered into an exclusive license agreement with Novartis for the U.S. commercialization rights to UTIBRON NEOHALER, as well as Seebri™ Neohaler® and Arcapta® Neohaler®, on December 21, 2016. Novartis received approval from the U.S. Food and Drug Administration (FDA) for UTIBRON NEOHALER in October 2015.

Sunovion expects to launch SEEBRI NEOHALER, which was approved by the FDA in 2015, and begin promotion of ARCAPTA NEOHALER, which was launched in the U.S. in 2012, in the U.S. during fiscal year 2017 (April 2017-March 2018).