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2017-11-01

AstraZeneca: AstraZeneca provides update on tralokinumab Phase III Programme in severe, uncontrolled asthma

AstraZeneca and its global biologics research and development arm,
MedImmune, today announced the top-line results of the Phase III
STRATOS 2 and TROPOS trials for tralokinumab, an anti-interleukin-13
(IL-13) human monoclonal antibody, in severe, uncontrolled asthma.

In STRATOS 2, tralokinumab did not achieve a statistically-significant
reduction in the annual asthma exacerbation rate (AAER), the primary
endpoint, in patients with severe, uncontrolled asthma and elevated
levels of a biomarker, Fractional exhaled Nitric Oxide (FeNO),
compared to placebo.

In TROPOS, tralokinumab did not achieve a statistically-significant
reduction in oral corticosteroid (OCS) use, the primary endpoint,
when added to the standard of care, in patients dependent on OCS.

Sean Bohen, Executive Vice President, Global Medicines Development and
Chief Medical Officer, said: "The results are disappointing as we had
hoped that tralokinumab would benefit patients with severe asthma,
which is a complex disease with limited treatment options today."

FeNO is a well-established biomarker for airway inflammation and was
identified in the previous pivotal trial (STRATOS 1) as most likely
to predict an enhanced response to tralokinumab.

The safety and tolerability findings in STRATOS 2 and TROPOS were
consistent with those observed in previous trials with tralokinumab.

Full data from STRATOS 1, STRATOS 2 and TROPOS will be presented at a
forthcoming medical meeting.

-ENDS-

NOTES TO EDITORS

About Severe Asthma

Asthma affects 315 million individuals worldwide, and up to 10% of
asthma patients have severe asthma, which may be uncontrolled despite
high doses of standard-of-care asthma controller medicines and can
require the use of chronic OCS.

Severe, uncontrolled asthma is debilitating and potentially fatal with
patients experiencing frequent exacerbations and significant
limitations on lung function and quality of life.

Severe, uncontrolled asthma can lead to a dependence on OCS, with
systemic steroid exposure potentially leading to serious short- and
long-term adverse effects, including weight gain, diabetes,
osteoporosis, glaucoma, anxiety, depression, cardiovascular disease
and immunosuppression. There is also a significant physical and
socio-economic burden of severe, uncontrolled asthma with these
patients accounting for 50% of asthma-related costs.

About Tralokinumab

Tralokinumab is an anti-IL-13 human immunoglobulin-G4 monoclonal
antibody that blocks binding and signalling of IL-13 to IL-13
receptors. IL-13 is an important signalling protein that is a key
driver in asthma. When IL-13 binds to receptors (IL-13R?1 and
IL-13R?2) found on cells in the airways, it can lead to inflammation,
hypersensitivity and structural changes.

About FeNO

In asthma, FeNO (fractional exhaled nitric oxide) is a
well-established biomarker for T2 airway inflammation driven by
T-helper cells type 2 (Th2). IL-13 and IL-4 are two inflammatory
cytokines produced by Th2 cells. These cytokines induce the release
of nitric oxide (NO) from airway epithelial cells which can be
measured in expired breath (FeNO).

About the ATMOSPHERE Programme

The ATMOSPHERE programme is comprised of 2,298 patients at 571 sites
across 27 countries including the pivotal efficacy trials, STRATOS 1
and STRATOS 2, along with the TROPOS, MESOS and Japan Long-Term
Safety (LTS) trials.

STRATOS 1 and 2 are Phase III multicentre, randomised, double-blinded,
parallel-group, placebo-controlled trials designed to evaluate the
efficacy and safety of a regular, subcutaneous administration of
tralokinumab for 52-weeks in adult and adolescent patients with
severe asthma inadequately controlled despite treatment with inhaled
corticosteroids (ICS) plus LABA. STRATOS 1 also explored potential
biomarkers to identify patients with an enhanced response to
tralokinumab and identified FeNO as the lead biomarker. STRATOS 2
sought to validate this.

TROPOS is a Phase III multicentre, randomised, double-blinded,
parallel-group, placebo-controlled trial for 40-weeks in adult and
adolescent patients with severe asthma who require continuous
treatment with ICS plus LABA, and chronic treatment with maintenance
oral corticosteroid (OCS) therapy.

MESOS is a Phase II multicentre, randomised, double-blinded, parallel
group, placebo-controlled trial for 12-weeks designed to evaluate the
effect of tralokinumab administered subcutaneously every 2-weeks on
airway inflammation in adults with uncontrolled asthma requiring
continuous treatment with ICS, with or without other asthma
controllers.

Japan LTS is an open-label, multicentre trial to evaluate the safety
of tralokinumab for 52-weeks in Japanese adults and adolescents with
asthma inadequately controlled on ICS plus LABA.

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-5r?), which has been accepted for
regulatory review in the US, EU and Japan, 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 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
Oncology, Respiratory, Cardiovascular & Metabolic Diseases, and
Infection and Vaccines. The MedImmune headquarters is 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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