AstraZeneca to highlight the breadth of its respiratory medicines at American Thoracic Society 2016 International Conference

New data reflect advancements across novel inhaled therapies, respiratory biologics and research into underlying disease pathways

12 May 2016

AstraZeneca will demonstrate the breadth and depth of its industry-leading respiratory disease medicines with more than 60 abstracts and scientific presentations at the American Thoracic Society (ATS) 2016 International Conference in San Francisco, California, 13-18 May 2016.

Data support AstraZeneca’s novel inhaled combinations, respiratory biologics and innovative science, which targets new pathways in asthma and chronic obstructive pulmonary disease (COPD). Highlights include:

• 14 abstracts focused on unmet need in COPD as well as Bevespi Aerosphere (glycopyrrolate/formoterol fumarate), recently approved by the US FDA, a novel fixed-dose dual bronchodilator pMDI utilising the latest co-suspension technology for the treatment of COPD, including 24-hour lung function data compared to tiotropium bromide inhalation spray and placebo.
• Biomarker data on benralizumab, an anti–eosinophil monoclonal antibody currently in Phase III trials in both severe asthma and COPD. The data evaluate the potential for high baseline blood eosinophils as well as baseline serum biomarkers of the IL-13 pathway to predict treatment response. These data may be of value for both benralizumab and tralokinumab (IL-13 monoclonal antibody).
• Data highlighting breakthrough science aimed at addressing and potentially modifying the underlying causes of respiratory diseases, with a research focus on four key biological pathways: eosinophilic disease, Th2-driven disease, epithelial-driven pathobiology and autoimmunity.

In addition, data will be presented evaluating the effects on lung function and airway inflammation of Daxas (roflumilast), the oral PDE4 inhibitor, initiated in addition to standard therapy with corticosteroids and antibiotics at the onset of an acute exacerbation of COPD.

Tom Keith-Roach, Vice President, Global Product Strategy for Respiratory, Inflammation and Autoimmunity, said: “Respiratory is one of AstraZeneca’s main therapy areas and it’s exciting that the data being shared at ATS demonstrate how rapidly our pipeline and portfolio are developing. We believe Bevespi Aerosphere and investigational medicines such as benralizumab can make a real difference in the lives of patients living with respiratory conditions worldwide.”

AstraZeneca/MedImmune key presentations at ATS 2016

COPD, Bevespi Aerosphere (glycopyrrolate/formoterol fumarate) and PT010 (budesonide/glycopyrrolate/formoterol)

SYMBICORT (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol

Respiratory Biologics

Eklira (aclidinium)

Duaklir (aclidinium/formoterol)

Daliresp/Daxas (roflumilast)

Emerging and Disease Modification Science

About Asthma

Asthma is a common, chronic condition in which inflammation and narrowing of the airways may cause wheezing, breathlessness, chest tightness and coughing. Despite current and available treatment options, asthma continues to effect the health and day-to-day lifestyles of more than 300 million children, men and women worldwide. By 2020, asthma will likely increase in numbers to affect as many as 400 million people.

Approximately 10% of asthma is severe, of which a reported 40% is uncontrolled. Severe, uncontrolled asthma has eight times higher risk of mortality. Uncontrolled asthma can lead to a dependence on oral corticosteroids (OCS). Systemic steroid exposure leads to serious & irreversible adverse effects, including osteoporosis, anxiety, depression, weight gain, glaucoma and diabetes. There is also a significant physical and socio-economic burden of asthma with 10% of severe patients accounting for 50% of asthma related health costs.

About COPD

COPD (chronic obstructive pulmonary disease) 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 2030. Improving lung function and managing daily symptoms such as breathlessness are important to the management of COPD. It is estimated that eight out of 10 patients suffer symptoms at night, such as an irritative cough and difficulty breathing, frequent nocturnal awakenings, which leads to insomnia, worry and anxiety.

About Respiratory, Inflammation and Autoimmunity Diseases

Respiratory, Inflammation and Autoimmunity (RIA) is one of AstraZeneca’s main therapy areas, and we have a growing portfolio of medicines that reached more than 17 million patients in 2015. Our strong pipeline has the potential to deliver up to seven launches between 2016 and 2020. In respiratory disease, our aim is to transform asthma and COPD treatment through inhaled combinations at the core of care; precision biologics for the unmet needs of specific patient populations, and scientific advancements in disease modification. We are building on a 40-year heritage in respiratory disease, and our capability in inhalation technology spans both pressurised metered-dose inhalers (pMDIs) and dry powder inhalers (DPIs), as well as our unique Co-Suspension Technology.

In Inflammation and Autoimmunity, our aim is to develop innovative therapies for the treatment of autoimmune and rheumatoid diseases, with a lead programme in systemic lupus erythematosus. Across respiratory, inflammation and autoimmune diseases, our research is focused on four key biological pathways: eosinophilic disease, Th2-driven disease, epithelial-driven pathobiology, and autoimmunity.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com.

CONTACTS

Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and Metabolic Disease,

ING - Infection, Neuroscience and Gastrointestinal