Press release
Nov 25, 2011

Novartis files NDA for NVA237 as a treatment for chronic obstructive pulmonary disease (COPD) in Japan

Tokyo, Japan – 25 November 2011: Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565), announces that Novartis Pharma K.K. filed an application today for sales and marketing approval of NVA237 (glycopyrronium bromide) for the treatment of adult patients with chronic obstructive pulmonary disease (COPD) in Japan.

NVA237 is a long-acting muscarinic antagonist (LAMA) submitted for approval in the European Union in September as a once-daily treatment for COPD under the brand name Seebri® Breezhaler®.

Mr. Shinichi Tamura, CEO of Sosei, said: “Filing of NVA237 in Japan represents an important milestone for us, and we are very happy to see that development of NVA237 is progressing to plan. It is estimated that over 5 million people in Japan suffer from COPD and we are looking forward to seeing this drug being delivered to patients in the near future.”

Furthermore, Novartis Pharma K.K. announced on 18 November that it had reached an agreement with Eisai Co. Ltd. regarding a co-promotion contract for up to three therapies for chronic obstructive pulmonary disease (COPD). These include Onbrez® 150 mcg Capsules for Inhalation (indacaterol maleate), and, if approved, NVA237 and QVA149 (a fixed-dose combination of indacaterol and NVA237).