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Sosei Heptares Announces That the COPD Treatment Ultibro® Breezhaler® has been Included in the National Reimbursement Drug List in China

TOKYO and LONDON, Nov. 28, 2019 /PRNewswire/ -- Sosei Group Corporation ("the Company";) (TSE: 4565) announces that Ultibro® Breezhaler® (an inhaled once-daily fixed-dose combination of indacaterol/glycopyrronium bromide) has been included in the 2019 National Reimbursement Drug List (NRDL) in China for the treatment of chronic obstructive pulmonary disease (COPD). The product was launched in China in March 2019, along with related product Seebri® Breezhaler® and both are approved for use in over 100 countries worldwide, including countries within the EU and Latin America, Japan, Canada, Switzerland and Australia.

The NRDL is a list of therapies that are partially, if not fully, reimbursed for eligible patients. The list is approved nationally with the aim of providing basic medical coverage to China's population of 1.4 billion. The list covers well-established medicines as well as newer, innovative medicines.

Glycopyrronium bromide and certain use and formulation intellectual property were exclusively licensed to Novartis in April 2005 by Sosei Heptares and Vectura. Sosei Heptares is eligible to receive royalties on global product net sales.

Shinichi Tamura, Chairman, President and CEO of Sosei Heptares, said: "We are pleased that COPD patients in China will have improved access to this novel inhaled product through the inclusion in the 2019 NRDL. COPD is the fourth leading cause of death in China1 and a major public-health problem affecting nearly 100 million people2. Ultibro® has shown to be effective in managing COPD symptoms to improve lung function and quality of life and to reduce the incidence of acute exacerbations. Broadened access to new COPD treatments in China could significantly improve the lives of those patients most in need."

The event reported today does not generate a milestone payment and therefore has no immediate impact on the consolidated financial results for the accounting period ending December 2019.

About Ultibro® Breezhaler® 

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).

Ultibro® Breezhaler® and Seebri® Breezhaler® are being 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, which are controlled subsidiaries of Novartis.

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

References

1 http://www.nhc.gov.cn.

2 Wang C, Xu J, Yang L, et al. Lancet 2018; 391:1706–17.

About Sosei Heptares

We are an international biopharmaceutical group focused on the discovery and early development of new medicines originating from our proprietary GPCR-targeted StaR® technology and structure-based drug design platform capabilities. We are advancing a broad and deep pipeline of novel medicines across multiple therapeutic areas, including CNS, immuno-oncology, gastroenterology, inflammation and other rare/specialty indications.

We have established partnerships with some of the world's leading pharmaceutical companies, including Allergan, AstraZeneca, Daiichi-Sankyo, Genentech (Roche), Novartis, Pfizer and Takeda; and with innovative biotechnology companies, including Kymab, MorphoSys and PeptiDream. Sosei Heptares is headquartered in Tokyo, Japan with R&D facilities in Cambridge, UK.

"Sosei Heptares" is the corporate brand of Sosei Group Corporation, which is listed on the Tokyo Stock Exchange (ticker: 4565). Sosei, Heptares, the logo and StaR® are Trade Marks of Sosei Group companies.

Forward-looking statements

This press release contains forward-looking statements, including statements about the discovery, development and commercialization of products. Various risks may cause Sosei Group Corporation's actual results to differ materially from those expressed or implied by the forward-looking statements, including: adverse results in clinical development programs; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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