Press release
Mar 22, 2019

Sosei Heptares announces that Ultibro® Breezhaler® and Seebri® Breezhaler® launched in China for the treatment of COPD

Tokyo, Japan and London, UK, 22 March 2019 – Sosei Group Corporation (“the Company”; TSE: 4565) confirms that Ultibro® Breezhaler® and Seebri® Breezhaler® have been launched by Novartis in China for the treatment of chronic obstructive pulmonary disease (COPD). The Company, together with Vectura (LSE: VEC), exclusively licensed key intellectual property integral to the development of both products to Novartis in April 2005 and is eligible for royalties on global product sales.

Ultibro® Breezhaler® is an inhaled once-daily fixed-dose combination of indacaterol (a long-acting beta 2 agonist; LABA) and glycopyrronium bromide (a long-acting muscarinic antagonist; LAMA) and Seebri® Breezhaler® is an inhaled fixed-dose formulation of glycopyrronium bromide (a long-acting muscarinic antagonist; LAMA). Both products are approved and launched in over 90 countries worldwide, including the US, EU and Japan. Ultibro®Breezhaler® is the leading LABA/LAMA in Europe and continues to show continued global growth (+10% in FY2018 vs. FY2017), driven by positive FLAME and CLAIM clinical study results as well as the GOLD Strategy 2018 Report.

Both products will be promoted in China by Huizheng (Shanghai) Technology Co., Ltd. (“Huizheng”), a group company of Zheijiang Hisun Pharmaceutical Co., Ltd. (SHG: 600267) under license from Beijing Novartis Pharma Co., Ltd and Sandoz (China) Pharmaceutical Co., Ltd, both controlled subsidiaries of Novartis.

Huizheng has applied to include Ultibro® Breezhaler® and Seebri® Breezhaler® in the National Health Insurance Drug List.

COPD is the fourth leading cause of death in China[1], and affects nearly 100 million people in China[2]. According to IMS, in 2017, the anti-asthma and COPD market was estimated to be ~RMB11.043bn (~US$1.65bn) in China, and the sales of long-acting inhaled bronchodilators is ~RMB5.8bn (~US$870m).

Shinichi Tamura, Chairman, President & CEO of Sosei Heptares, said: “We are delighted that Novartis has launched Ultibro® Breezhaler® and Seebri® Breezhaler® in China. In a large, nationally representative sample of adults aged 40 years or older, the estimated overall prevalence of COPD in China in 2014–2015 was 13.6%, indicating that this disease has become a major public-health problem. Strategies aimed at prevention and treatment of COPD are needed urgently. ”[3] 

The effect of the launch on our consolidated financial results for the accounting period ending December 2019 has not yet been determined. After determination thereof, any material matters will be announced promptly.

– Ends –

[2] Wang C, Xu J, Yang L, et al. Lancet 2018; 391:1706–17.
[3] Fang L, Gao P, Bao H, Tang X, Wang B, Feng Y et al. Lancet Respiratory Medicine 2018; 6: 421-430