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2017-09-11

AstraZeneca: Astrazeneca presents new results identifying severe asthma patients who would benefit most from Benralizumab

Further analysis of the Phase III trials, SIROCCO and CALIMA,
reinforces benralizumab's efficacy and identifies more frequent prior
exacerbations and/or greater baseline blood eosinophil count as key
predictors of an enhanced treatment effect

Findings pave the way for a personalised treatment approach to guide
more precise selection of the benralizumab-responsive patient and
help achieve maximum clinical benefit

11 September 2017

AstraZeneca today announced results from a subgroup analysis of the
SIROCCO and CALIMA Phase III trials. The results confirm
benralizumab's compelling efficacy and identify key factors that
predict which patients with severe, uncontrolled asthma would respond
best to treatment with this potential new medicine.

Benralizumab is a monoclonal antibody that recruits natural killer
cells, a component of the innate immune system, causing direct, rapid
and near-complete depletion of eosinophils. Eosinophils are the
biological effector cells that impact airway inflammation and airway
hyper-responsiveness in approximately 50% of asthma patients, which
leads to increased asthma symptoms, impaired lung function and more
frequent exacerbations.

In this post-hoc analysis, benralizumab demonstrated efficacy across
the full range of baseline blood eosinophil counts, with an increased
number of prior exacerbations and a higher baseline blood eosinophil
count associated with a greater treatment effect. A combination of
both higher baseline blood eosinophil count and a history of more
frequent exacerbations predicted an even greater magnitude of
response for patients treated with benralizumab. Additionally,
patients on oral corticosteroids and with nasal polyposis were more
likely to have an enhanced treatment response. The results are being
presented at the European Respiratory Society (ERS) International
Congress 2017 in Milan, Italy and published simultaneously today in
The Lancet Respiratory Medicine.
(http://www.thelancet.com/journals/lanres/article/PIIS2213-2600(17)30344-2/fulltext?elsca1=tlxpr)

The overall safety profiles of the benralizumab and placebo arms were
similar for both the SIROCCO and CALIMA trials, and the overall
safety profile for benralizumab was in line with prior experiences.

J. Mark FitzGerald, MD, Director of the Centre for Heart and Lung
Health at the Vancouver Coastal Health Research Institute and
Principal Investigator of the study, said: "As a treating physician,
I want to be confident that I am prescribing the right treatment that
will provide maximum benefit to patients with severe, uncontrolled
asthma. This important analysis shows benralizumab provides enhanced
benefits for patients who experience more frequent exacerbations
despite being on standard-of-care medicines and/or who present with
higher baseline blood eosinophil counts. Knowing this will help us
identify which patients can benefit most from benralizumab, and will
ultimately help us improve the therapeutic management of severe,
uncontrolled asthma."

Colin Reisner, Head of Respiratory, Global Medicines Development at
AstraZeneca, said: "Severe, uncontrolled asthma affects millions of
people around the world and exacerbations can be life-threatening.
This new analysis of SIROCCO and CALIMA builds on robust clinical
evidence supporting benralizumab for patients with severe,
uncontrolled asthma, including more recent data from the Phase III
ZONDA trial."

Benralizumab is under regulatory review in the US, EU, Japan and
several other countries, with a US PDUFA date during the fourth
quarter of 2017 and expected regulatory decisions elsewhere during H1
2018.

- 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 oral corticosteroids (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 has an eight times higher risk of mortality than
severe asthma.

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 the WINDWARD Programme
The WINDWARD programme in asthma is made up six Phase III trials,
including SIROCCO, CALIMA, ZONDA, BISE, BORA and GREGALE. The two
pivotal trials included in this analysis, SIROCCO
(http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)31324-1/abstract)
and CALIMA
(http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)31322-8/abstract),
are randomised, double-blinded, parallel-group, placebo-controlled
trials designed to evaluate the efficacy and safety of a regular,
subcutaneous administration of benralizumab (fixed 30mg dose) for up
to 56 weeks in exacerbation-prone adult and adolescent patients 12
years of age and older.

A total of 2,295 patients (1,204 in SIROCCO and 1,091 in CALIMA)
received standard-of-care medicine (including high-dosage inhaled
corticosteroids and long-acting beta-2 agonists [ICS/LABA]) and were
randomised globally and received either benralizumab 30mg every 4
weeks; benralizumab 30mg every 4 weeks for the first three doses
followed by 30mg every 8 weeks; or placebo. All benralizumab doses
were administered via subcutaneous injection using an accessorised
pre-filled syringe.

The third registrational trial, ZONDA, demonstrated a
statistically-significant and clinically-meaningful reduction in
daily-maintenance, OCS use compared with placebo for patients with
severe, uncontrolled OCS-dependent eosinophilic asthma receiving
benralizumab. Patients treated with benralizumab achieved a median
reduction in OCS dose of 75%, and were more than four times as likely
to reduce their OCS dose than those on placebo. The results were
published in the New England Journal of Medicine
(http://www.nejm.org/doi/full/10.1056/NEJMoa1703501) in May 2017.

In addition to WINDWARD, the Phase III VOYAGER programme is currently
underway, which is evaluating the efficacy and safety of benralizumab
in patients with severe, chronic obstructive pulmonary disease
(COPD).

About Benralizumab
Benralizumab is a monoclonal antibody that recruits natural killer
cells causing direct, rapid and near complete depletion of
eosinophils. Depletion of circulating eosinophils is rapid, with an
onset of action within 24 hours as confirmed in early phase I/II
trials. In the pivotal Phase III trials, SIROCCO and CALIMA,
benralizumab demonstrated significant reduction in exacerbations and
improved lung function and asthma symptoms in severe, uncontrolled
eosinophilic asthma patients. Eosinophils are the biological effector
cells in approximately 50% of asthma patients, leading to frequent
exacerbations, impaired lung function and asthma symptoms.
Benralizumab is not approved anywhere in the world, but is under
regulatory review in the US, EU, Japan and several other countries.

Benralizumab was developed by MedImmune, AstraZeneca's global
biologics research and development arm and is in-licensed from BioWa,
Inc., a wholly-owned subsidiary of Kyowa Hakko Kirin Co., Ltd.,
Japan.

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-SuspensionTMDelivery 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 trials, 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 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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