Press release
Aug 26, 2013

First in class once-daily dual bronchodilator QVA149 gains endorsement for approval from Drug Committee of MHLW (Ministry of Health, Labour and Welfare) for the treatment of COPD in Japan

Tokyo, Japan – 26 August 2013: Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565) confirms that the Drug Committee of MHLW has endorsed approval of once-daily QVA149 (glycopyrronium / indacaterol), developed by Novartis, as a treatment to relieve symptoms due to airway obstruction in chronic obstructive pulmonary disease (COPD) in Japan. The Japanese MHLW is expected to follow with approval in due course.

In July 2013, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the approval of QVA149 in Europe under the brand name Ultibro® Breezhaler®.

Ultibro ® and Breezhaler® are registered trademarks of Novartis AG.