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2017-09-04

AstraZeneca: AstraZeneca to present data on next generation of biologics at European Respiratory Society International Cong...

Presentation of the PATHWAY Phase IIb data for tezepelumab, a
first-in-class treatment that blocks thymic stromal lymphopoietin
(TSLP), in patients with severe, uncontrolled asthma

New analysis of benralizumab Phase III trials, SIROCCO and CALIMA,
which reinforces the potential new medicine's efficacy and identifies
key predictors of an enhanced treatment effect

AstraZeneca and its global biologics research and development arm,
MedImmune, will present new data on its respiratory portfolio and
pipeline at the European Respiratory Society (ERS) International
Congress, 9-13 September 2017 in Milan, Italy. The breadth and depth
of science are reflected in the 48 accepted abstracts, including 11
oral presentations, which will focus on areas of unmet treatment
needs in asthma and chronic obstructive pulmonary disease (COPD).

Highlights will cover rapidly-advancing research on the next
generation of biologics that target the underlying drivers of
respiratory disease. In particular, the full tezepelumab PATHWAY
Phase IIb data in patients with severe, uncontrolled asthma will be
presented as a late-breaking abstract at ERS. Tezepelumab is a
first-in-class biologic targeting thymic stromal lymphopoietin
(TSLP), an upstream `master-switch' that drives multiple inflammatory
pathways in asthma. Additionally, a new analysis of the benralizumab
SIROCCO and CALIMA Phase III trials in severe, uncontrolled asthma
will reinforce the potential new medicine's efficacy and will
identify those patients who may have an enhanced response to the new
medicine.

Tom Keith-Roach, Vice President, Respiratory at AstraZeneca, said:
"The tezepelumab and benralizumab data at the ERS Congress represent
the next generation of respiratory biologics that have the potential
to truly transform asthma care by targeting the underlying causes of
the disease. Respiratory is one of AstraZeneca's three main therapy
areas and we are excited to demonstrate the strength of our science
and the breadth of our rapidly-expanding portfolio with 48 abstracts
covering emerging science and new inhaled treatment paradigms."

Advancing biologics in severe, uncontrolled asthma

· Results from the tezepelumab PATHWAY Phase IIb study which
evaluates the impact of tezepelumab on exacerbations in patients with
severe, uncontrolled asthma (Late-breaking abstract OA3189 with oral
presentation).

Growing body of data to support benralizumab - a potential new
medicine

· Post-hoc analysis of the benralizumab SIROCCO and CALIMA Phase III
trials which identifies key factors that predict an enhanced response
to benralizumab for severe, uncontrolled asthma (Late-breaking
abstract OA2902 with oral presentation).

· Benralizumab attenuates airway eosinophilopoietic processes in
prednisone-dependent asthma (Abstract OA3217 with oral presentation).

· Asthma patients with high blood eosinophil counts have a greater
risk of rehospitalisation for exacerbations (Abstract OA3214 with
oral presentation).

New evidence on the protective benefit of Symbicort
(budesonide/formoterol) in COPD patients at risk of exacerbation

· Results from INCONTROL 1, a first-of-its-kind post-hoc analysis of
a large pooled data set of Phase III COPD studies, investigate
patient characteristics that may interact with the treatment response
to budesonide/formoterol versus formoterol alone. The analysis also
examines the relationship between blood eosinophil levels, risk of
exacerbation and treatment selection in COPD (Abstract PA394 with
poster discussion).

Breakthrough science in disease modification

Data highlighting our evolving scientific understanding of disease
modification and personalised medicine, including:

· New data on the role of rhinovirus infection as a cause of the
dysfunctional anti-bacterial mechanisms contributing to exacerbations
in COPD (Abstract OA286 with oral presentation).

· Novel approaches for the segmentation of asthma patients based on
biological disease drivers such as activation of eosinophils, Th17
and PI3Kgd (Abstracts PA1131, PA569 with poster discussion,
late-breaking abstract OA2933 with oral presentation, and PA4920 with
poster discussion).

Breakthrough science in drug delivery technology

· New data evaluates how Functional Respiratory Imaging (FRI) helps
characterise the physiological effect of PT003
(glycopyrrolate/formoterol fumarate MDI) formulated using the novel
AerosphereTMDelivery Technology, supporting lung function endpoint
improvements in COPD. (Late breaking abstract OA4404 with podium
presentation)

- ENDS -

NOTES TO EDITORS

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
Co-SuspensionTM Delivery Technology. The company's biologics include
benralizumab (anti-eosinophil, anti-IL-5r?), which has been accepted
for regulatory review in the US, EU and Japan, tralokinumab
(anti-IL-13), which is currently in Phase III, and tezepelumab
(anti-TSLP), which successfully achieved its Phase IIb primary
endpoint. AstraZeneca's research is focused on addressing underlying
disease drivers focusing on the lung epithelium, lung immunity and
lung regeneration

About MedImmune
MedImmune is the global biologics research and development arm of
AstraZeneca, a global, innovation-driven biopharmaceutical business
that focuses on the discovery, development and commercialisation of
small molecule and biologic prescription medicines. MedImmune is
pioneering innovative research and exploring novel pathways across
key therapeutic areas, including respiratory, inflammation and
autoimmunity; cardiovascular and metabolic disease; oncology;
neuroscience; and infection and vaccines. The MedImmune headquarters
is located in Gaithersburg, Md., one of AstraZeneca's three global
R&D centres, with additional sites in Cambridge, UK and Mountain
View, CA. For more information, please visit www.medimmune.com

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.

For more information, please visit www.astrazeneca.com and follow us
on Twitter @AstraZeneca.

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