Bevespi Aerosphere demonstrates statistically significant improvement in lung function in patients with COPD

AstraZenecaAstraZeneca today announced positive top-line results of the Phase III, PINNACLE 4 trial in which Bevespi Aerosphere* (glycopyrronium and formoterol fumarate 14.4/9.6 µg) demonstrated a statistically significant improvement in lung function as measured by trough forced expiratory volume in one second (FEV1), compared to its monotherapy components (glycopyrronium 14.4 µg and formoterol fumarate 9.6 µg) and placebo, all administered twice daily via pressurised metered-dose inhaler (pMDI) to patients with moderate to very severe chronic obstructive pulmonary disease (COPD). AstraZeneca will make regulatory filing applications for Bevespi Aerosphere in Japan and China in 2018, based on data from PINNACLE 4, as well as previously reported trials.

Dr. Colin Reisner, Head of Respiratory, Global Medicines Development at AstraZeneca, said: "These positive results add to the strong established efficacy and safety profile of Bevespi Aerosphere in the treatment of patients with COPD. PINNACLE 4 will support our regulatory filings in Japan and China where respiratory diseases such as COPD remain a significant and growing public health burden with unmet treatment needs."

The 24-week PINNACLE 4 trial was designed to provide data on the efficacy and safety of Bevespi Aerosphere. It included 1,756 patients across Asia, Europe and the US. Safety and tolerability data for Bevespi Aerosphere were consistent with previous trials. Data from PINNACLE 4 will be presented at a forthcoming medical meeting.

Bevespi Aerosphere is approved in the US for the long-term maintenance treatment of airflow obstruction in COPD. A Marketing Authorisation Application for Bevespi Aerosphere has been accepted for review by the European Medicines Agency with a regulatory decision anticipated in the second half of 2018.

About COPD
Chronic obstructive pulmonary disease (COPD) is a progressive disease associated mainly with tobacco smoking, air pollution or occupational exposure, which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness. It affects an estimated 329 million people worldwide and is predicted to be the third leading cause of death by 2020. Improving lung function, reducing exacerbations and managing daily symptoms such as breathlessness are important to the management of COPD.

In Japan, COPD represents a significant health, economic, social and psychological burden. It is the tenth leading cause of death.(1) In China, one in 10 adults over the age of 40 (2) lives with COPD and prevalence is increasing.(3) COPD is the third largest(4) cause of death among chronic diseases.

About the PINNACLE 4 Trial
The PINNACLE 4 trial is a randomised, double-blind, 24-week chronic-dosing, placebo-controlled, parallel-group, multi-centre trial to assess the efficacy and safety of Bevespi Aerosphere (glycopyrronium and formoterol fumarate 14.4/9.6 µg) administered twice daily via pressurised metered-dose inhaler (pMDI) compared to its monotherapy components glycopyrronium, 14.4 µg twice-daily pMDI, and formoterol fumarate, 9.6 µg twice-daily pMDI, and compared with placebo, in patients with moderate to very severe COPD.

The primary outcome was the change from baseline in morning pre-dose (trough) FEV1 for Bevespi Aerosphere 14.4/9.6 µg compared to formoterol fumarate, 9.6 µg twice-daily pMDI, glycopyrronium, 14.4 µg twice-daily pMDI, and placebo. Secondary outcomes included assessments of dyspnoea, health-related quality of life, time to onset and rescue medication use.

About Bevespi Aerosphere
Bevespi Aerosphere (glycopyrronium and formoterol fumarate) is a fixed-dose dual bronchodilator combining glycopyrronium, a long-acting muscarinic antagonist (LAMA), and formoterol fumarate, a long-acting beta-2 adrenergic agonist (LABA). Bevespi Aerosphere is the first and only LAMA/LABA with Aerosphere Delivery Technology. Aerosphere Delivery Technology is also the platform for investigational medicines including PT010, our triple combination of budesonide/glycopyrronium/formoterol fumarate.

The efficacy of Bevespi Aerosphere has been studied in more than 5,000 patients through the PINNACLE trial programme. In PINNACLE 1 and PINNACLE 2 trials, Bevespi Aerosphere demonstrated statistically-significant improvements in trough FEV1 versus glycopyrronium, formoterol fumarate and placebo.

About AstraZeneca in Respiratory Disease
Respiratory disease is one of AstraZeneca's main therapy areas, and the Company has a growing portfolio of medicines that reached more than 18 million patients in 2016. AstraZeneca's aim is to transform asthma and COPD treatment through inhaled combinations at the core of care, biologics for the unmet needs of specific patient populations, and scientific advancements in disease modification.

The Company is building on a 40-year heritage in respiratory disease and AstraZeneca's capability in inhalation technology spans both pMDIs and dry powder inhalers, as well as the innovative Aerosphere Delivery Technology. The company's biologics include benralizumab (anti-eosinophil, anti-IL-5rɑ), which has been accepted for regulatory review in the US, EU and Japan, tralokinumab (anti-IL-13), which is currently in Phase III trials, and tezepelumab (anti-TSLP), which successfully achieved its Phase IIb primary and secondary endpoints. AstraZeneca's research is focused on addressing underlying disease drivers focusing on the lung epithelium, lung immunity and lung regeneration.

About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

* Bevespi Aerosphere is a registered trademark of AstraZeneca. The trade name is subject to regulatory review and approval in other countries outside of the US. References

1. Ministry of Health, Labour and Welfare. Summary of population dynamics statistics in Heisei: Number of deaths/mortality rate by rank of death factors by gender. [Online]. Available at: http://www.mhlw.go.jp/toukei/saikin/hw/jinkou/kakutei15/dl/10_h6.pdf Last accessed September 2017.
2. Chinese nutrition and chronic disease report (2015), China National Health and Family Planning Commission.
3. Bao Heling, et al. Chinese Journal of Epidemiology. 2016,37 (1): 119-124.
4. Yang GH, et al. Lancet. 2013;381(9882):1987-2015.

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