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2014-05-12

AstraZeneca: AstraZeneca to present respiratory data at ATS 2014 international conference

Benralizumab and tralokinumab data both show improvement in key
measures of asthma control for patients with specific, severe forms
of asthma

Data underscore strength and breadth of AstraZeneca's respiratory
pipeline

AstraZeneca today announced that MedImmune, its global biologics
research and development arm, will present Phase IIb data on two
novel investigational molecules - benralizumab and tralokinumab - at
the upcoming American Thoracic Society (ATS) 2014 International
Conference being held in San Diego, California, 16-21 May.

In the Phase IIb data being presented, both benralizumab and
tralokinumab show promising safety and efficacy outcomes, suggesting
they may offer important new therapeutic options for patients with
specific forms of severe, uncontrolled asthma.

"AstraZeneca is pioneering innovative research and exploring novel
pathways in respiratory disease, one of our core therapeutic areas,
and we have a diverse emerging pipeline covering a broad set of
patients. Our approach leverages AstraZeneca and MedImmune's combined
expertise in monoclonal antibody research with our broad experience
in drug development," said Dr. Bahija Jallal, Executive Vice
President, MedImmune. "We are applying translational approaches and
generating clinical data that put us in a good position to understand
the biology, disease phenotypes and new drug combinations that will
help drive step-changes in clinical outcomes for asthma patients."

MedImmune is presenting Phase IIb asthma data on benralizumab, an
investigational monoclonal antibody binding to the interleukin-5
receptor alpha (IL-5Rα). Benralizumab has a unique mode of action as
it binds to IL-5Rα on eosinophils and subsequently depletes
eosinophils by inducing antibody dependent cellular cytotoxicity.
Eosinophils are white blood cells that are a key target in
inflammatory respiratory diseases such as asthma and Chronic
Obstructive Pulmonary Disease (COPD). Scientific literature supports
that elevated eosinophil levels are associated with the cause and
severity of asthma and asthma exacerbations, as well as COPD
exacerbations.

In the Phase IIb study, subjects with uncontrolled severe asthma and
elevated baseline blood eosinophil levels taking benralizumab had a
statistically significant reduction in their asthma exacerbation rate
(AER), as well as improvements in lung function (FEV1) and asthma
control versus subjects taking placebo over a period of one year.
Specifically, the study showed that benralizumab decreased blood
eosinophil counts to very low levels after the first dose, and
reduced asthma attacks by approximately 40-70 percent depending on
dose received and baseline blood eosinophil level. (Abstract 3699,
presentation 19 May at 2:00pm PDT)

The company is also presenting Phase IIb data for tralokinumab, a
human monoclonal antibody which potently and selectively neutralises
interleukin-13 (IL-13), a key cytokine considered to be a central
mediator of asthma. The study recruited a broad (all-comer)
intent-to-treat population with severe uncontrolled asthma allowing
subgroup analyses of sub-populations with biomarkers indicating an
IL-13 pathogenesis. The study did not meet its primary endpoint of
reduction in AER in the all-comer population versus placebo. However,
reversible and periostin-high subgroup AER reductions were 54 percent
(-65, 87 percent) and when excluding subjects receiving oral
corticosteroids, 67 percent (2, 89 percent). Improved lung function
(FEV1) and improvement in patient-reported measures and
health-related quality of life (AQLQ) were observed in periostin-high
subgroups of patients along with high airway reversibility in
patients who received treatment every two weeks versus placebo.
(A6670, presentation 20 May at 8:15am PDT)

As previously communicated, benralizumab is currently in Phase III
development for asthma. A personalised healthcare strategy is
included in the company's trial design and a simple blood test is
used to identify patients with elevated blood eosinophils who are
most likely to respond to therapy.

The company intends to move tralokinumab into Phase III development
for asthma and benralizumab into Phase IIl for COPD later this year.
Further details will be communicated once the first patient is dosed
in a Phase III programme.

In the benralizumab and tralokinumab trials to date, frequencies of
treatment emergent serious adverse events/adverse events have been
similar within treatment and placebo groups.

"It is encouraging that benralizumab is positively affecting lung
function and asthma control in addition to reducing the rate of
exacerbations in patients with elevated eosinophils. Tralokinumab is
also showing positive effect in patients with potential biomarkers
for IL-13, which helps us identify a path forward in Phase III
trials," said Dr. Bing Yao, Senior Vice President and Head of
MedImmune's Respiratory, Inflammation and Autoimmunity Innovative
Medicines Unit. "Our scientists are using the necessary biomarkers to
identify which patients are most likely to benefit from our
respiratory therapies, opening doors of exploration into new and
improved treatment pathways for patient care."

AstraZeneca and MedImmune will present a combined 33 abstracts at ATS.
Other accepted abstracts of note include:

· Dosing studies of PT003, a combination of glycopyrronium and
formoterol fumarate in a pressurised metered-dose inhaler being
developed by AstraZeneca's Pearl Therapeutics. (A3758 and A3759, both
presentations 19 May at 2:00pm PDT)

· Analyses of database and survey data examining the association
between higher sputum and blood eosinophils and more frequent asthma
attacks. (A2311, presentation 18 May at 2:00pm PDT, and A4235,
presentation 20 May at 8:15am PDT)

· Benralizumab Phase IIa COPD data will be presented (A3771,
presentation 19 May at 2:00pm PDT)

AstraZeneca will host a briefing for analysts and investors during the
ATS conference, to be held in San Diego on 20 May 2014.

- ENDS -

NOTES TO EDITORS

Note: data beyond what is included in the abstracts are embargoed
until date and time of presentation at ATS.

About benralizumab

Benralizumab is a humanized monoclonal antibody directed at the alpha
subunit of the interleukin-5 receptor (IL-5Rα) that depletes
eosinophils, a key target cell in inflammatory respiratory disease.
Scientific literature supports that eosinophil levels are associated
with exacerbations and increased eosinophils are associated with
frequent exacerbations. In October 2013, AstraZeneca announced the
start of the Phase III Windward programme for benralizumab. The goal
of CALIMA, the first study in the Windward programme, is to determine
whether benralizumab reduces the number of exacerbations in patients
with severe asthma that remains uncontrolled, despite receiving high
doses of inhaled corticosteroids in combination with a second
controller such as a long-acting beta agonist.

An estimated 5 to 10 percent of the 300 million people worldwide who
suffer from asthma have a severe form, and people with eosinophilic
airway inflammation represent approximately 40 to 60 percent of the
severe asthmatic population.

Benralizumab is in-licensed from BioWa, Inc., a wholly-owned
subsidiary of Kyowa Hakko Kirin Co., Ltd.

About tralokinumab

Tralokinumab is a human IgG4 monoclonal antibody that targets IL-13, a
key cytokine that is believed to play a key role in the pathogenesis
of asthma through the promotion of inflammation, airway
hyper-responsiveness, mucus hyper-secretion, airway remodeling via
fibrosis, increased IgE synthesis and mast cell activation.

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 commercialization 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 centers. For more information, please visit www.medimmune.com.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business
that focuses on the discovery, development and commercialization 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

Media Enquiries

Esra Erkal-Paler +44 20 7604 8030 (UK/Global)
Vanessa Rhodes +44 20 7604 8037 (UK/Global)
Ayesha Bharmal +44 20 7604 8034 (UK/Global)
Susannah Budington +1 301 398 6717 (US)
Jacob Lund +46 8 553 260 20 (Sweden)

Investor Enquiries

Karl Hård +44 20 7604 8123  mob: +44 7789 654364
Colleen Proctor + 1 302 886 1842 mob: +1 302 357 4882
Anthony Brown +44 20 7604 8067 mob: +44 7585 404943
Jens Lindberg +44 20 7604 8414 mob: +44 7557 319729

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