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2018-09-18

AstraZeneca: Fasenra shows consistent safety and sustained efficacy in long-term Phase III BORA trial in severe eosinophili...

74% of continuously-treated patients with a blood eosinophil count of
300 or greater were exacerbation-free in the second year of treatment

Data presented at the European Respiratory Society (ERS) International
Congress 2018

AstraZeneca today announced results from the BORA Phase III extension
trial evaluating the long-term safety and efficacy of Fasenra
(benralizumab) as an add-on maintenance treatment in patients with
severe eosinophilic asthma who had previously completed one of the
two pivotal SIROCCO or CALIMA Phase III trials.

In the BORA trial, Fasenra given for an additional 56 weeks showed a
safety and tolerability profile similar to that observed in the
placebo-controlled SIROCCO and CALIMA trials, with no increase in the
frequencies of overall or serious adverse events. The improvements in
efficacy measures observed with Fasenra in the SIROCCO or CALIMA
trials were maintained over the second year of treatment. Patients
who were treated with placebo in the SIROCCO or CALIMA trials and
subsequently transitioned to Fasenra in the BORA trial experienced
improvements in efficacy outcomes consistent with those observed for
Fasenra-treated patients in the previous trials.1

74% of patients with a baseline blood eosinophil count of 300 cells
per ?L or greater (the primary efficacy population in the Phase III
trials) who received Fasenra every eight weeks continuously from
SIROCCO or CALIMA and into BORA, were exacerbation-free in BORA in
their second year of treatment and maintained improvements in lung
function and asthma control.1

65% and 66%, respectively, of patients with a baseline blood
eosinophil count of 300 cells per ?L or greater who received Fasenra
30 mg every eight weeks were exacerbation-free in their first year of
treatment in the one-year, predecessor SIROCCO and CALIMA trials (49%
for placebo arms in both trials).2,3

The BORA data will be presented today during a late-breaking oral
session at the European Respiratory Society (ERS) International
Congress 2018 in Paris, France.

Sean Bohen, Executive Vice President, Global Medicines Development and
Chief Medical Officer, said: "The BORA data are important news for
patients with severe eosinophilic asthma who need a treatment with
sustained efficacy to help control their disease, and with a safety
profile that supports long-term use."

Dr. William Busse, Professor of Medicine, Division of Allergy,
Pulmonary and Critical Care Medicine, University of Wisconsin School
of Medicine and Public Health, and lead investigator on BORA, said:
"As a clinician, I am excited by the BORA trial results, which
provide confidence to patients with severe eosinophilic asthma and
physicians that the positive outcomes they are seeing with Fasenra
can be maintained over a second year of treatment. In Fasenra, we
have a biologic treatment that can improve outcomes for these
patients long-term."

The overall annual asthma exacerbation rate for patients with baseline
blood eosinophil counts of 300 cells per ?L or greater who received
Fasenra every eight weeks continuously was consistent with the
predecessor SIROCCO and CALIMA trials (0.46 in BORA; 0.65 and 0.66 in
SIROCCO and CALIMA, respectively).2,3 Overall improvements in lung
function, asthma control, asthma-related and general health-related
quality of life scores were maintained for patients who received
Fasenra continuously and were improved for patients previously
receiving placebo in SIROCCO or CALIMA.1 Near complete eosinophil
depletion was maintained in patients who continuously received
Fasenra.1

The most commonly-reported adverse events (? 5%) in BORA were upper
respiratory tract infection, worsening asthma, headache, bronchitis
and acute sinusitis.1

Fasenra is AstraZeneca's first respiratory biologic and is approved as
an add-on maintenance treatment for severe eosinophilic asthma in the
US, EU, Japan and several other countries.

- ENDS -

NOTES TO EDITORS

About Severe Asthma

Asthma affects approximately 339 million individuals worldwide.4,5 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).6,7,8 Severe, uncontrolled asthma is debilitating and
potentially fatal with patients experiencing frequent exacerbations
and significant limitations on lung function and quality of
life.6,8,9,10 Severe, uncontrolled asthma has higher risk of
mortality than severe asthma.8

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.11,12,13,14 There is also a significant
physical and socio-economic burden of severe, uncontrolled asthma
with these patients accounting for 50% of asthma-related costs
despite compromising only 10% of the asthma population.7,15

Clinical features associated with an eosinophilic phenotype that can
act as markers for enhanced efficacy with targeted therapy in severe
eosinophilic asthma include: greater baseline blood eosinophil
counts, a history of more frequent exacerbations, chronic OCS use and
a history of nasal polyposis.8,16

About Fasenra

Fasenra is a monoclonal antibody that binds directly to the IL-5?
receptor on eosinophils, and attracts natural killer cells to induce
rapid and near-complete depletion of eosinophils via apoptosis
(programmed cell death).17,18 Eosinophils are a type of white blood
cell that are a normal part of the body's immune system and elevated
levels of eosinophils are seen in about half of severe asthma
patients.9,19 Elevated levels of eosinophils impact airway
inflammation and airway hyper-responsiveness, resulting in increased
asthma severity and symptoms, decreased lung function and increased
risk of exacerbations.7,9

Fasenra is AstraZeneca's first respiratory biologic, now approved as
an add-on treatment in severe eosinophilic asthma in the US, EU,
Japan, and several other countries, and under regulatory review in
several other jurisdictions. Where approved, Fasenra is available as
a fixed-dose subcutaneous injection via a prefilled syringe
administered once every four weeks for the first three doses, and
then once every eight weeks thereafter.20 Fasenra is also being
studied in severe nasal polyposis.

Fasenra was developed by AstraZeneca with MedImmune, the company'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 the BORA Trial

BORA is one of the six Phase III trials in the Fasenra WINDWARD
programme in asthma, which also includes SIROCCO, CALIMA, ZONDA, BISE
and GREGALE. BORA is a randomised, double-blind, parallel-group,
Phase III extension trial of patients who had completed one of the
three pivotal Phase III trials, SIROCCO, CALIMA or ZONDA.21 The
current analysis includes results for 1926 patients from the two
placebo-controlled exacerbation trials, SIROCCO (48 week) and CALIMA
(56 week). Patients continued add-on treatment with subcutaneous
Fasenra 30 mg every four weeks (Q4W) or every eight weeks (Q8W; first
three doses four weeks apart) or, for patients previously receiving
placebo, were re-randomised 1:1 to either Q4W or Q8W.

Once the BORA target enrolment had been achieved, adult patients who
wanted to continue treatment for a longer period of time had the
option to continue therapy in an additional open-label, long term
extension trial, without completing the full, planned follow up in
BORA. Approximately half of patients in the shorter (28 weeks) and
smaller ZONDA study went into an additional extension trial without
completing the planned 56-week treatment period in BORA. Therefore,
ZONDA patients were not included in this BORA analysis, and will be
reported separately according to the analysis plan.

Additional analyses from the BORA trial, including treatment in
adolescents up to 108 weeks, will be available in the second half of
2019.

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 2017. 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
pressurised metered-dose inhalers and dry powder inhalers, as well as
the Aerosphere Delivery Technology. The Company also has a growing
portfolio of respiratory biologics including Fasenra
(anti-eosinophil, anti-IL-5r?), now approved for severe eosinophilic
asthma and in development for severe nasal polyposis, and tezepelumab
(anti-TSLP), which is in Phase III trials and 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 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, Renal & Metabolism
and Respiratory. 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.

Media Relations
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Investor Relations
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