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AstraZeneca: Benralizumab Phase III trials show positive results in severe asthma

AstraZeneca's first biologic respiratory medicine met primary and key
secondary endpoints in pivotal trials for severe asthma

Results from pivotal Phase III trials presented at the European
Respiratory Society (ERS) International Congress demonstrated that
adding benralizumab to standard-of-care medicine significantly
reduced exacerbations and improved lung function and asthma symptoms
in severe asthma patients with an eosinophilic phenotype, as
indicated by the presence of eosinophils in their blood.

The SIROCCO and CALIMA trials evaluated the effect of two dosing
regimens of benralizumab 30mg administered in 4-week and 8-week
regimens as add-on therapy to standard-of-care medicine across
primary and key secondary endpoints. Results showed:

· Reductions in the annual rate of asthma exacerbations (up to 51%)
· Improvement in lung function (change in FEV1of up to 159 mL),
which was seen at 4 weeks after the first benralizumab dose and
sustained throughout the treatment period

· Improvement in asthma symptoms, such as wheeze, cough, chest
tightness and shortness of breath

The outcomes were demonstrated for the 8-week dosing regimen, with no
additional benefit observed with 4-week dosing, which may support
less-frequent dosing. In addition, post-hoc analysis showed greater
improvements in exacerbation rate reduction, FEV1 and total asthma
symptom scores in patients with a history of more frequent asthma
exacerbations (? 3 in the previous year). Detailed results were
published today in The Lancet for the Phase III SIROCCO

Sean Bohen, Executive Vice President, Global Medicines Development and
Chief Medical Officer, said: "Severe asthma affects the lives of
millions of patients around the world and can be life threatening.
The SIROCCO and CALIMA Phase III trials have shown that benralizumab
can offer a meaningful treatment option for patients as evidenced by
reductions in exacerbations, improvement in lung function and
symptoms, with the promise of fewer doses a year. Benralizumab has a
unique way of working in patients with severe asthma with an
eosinophilic phenotype and reflects AstraZeneca's progress in
bringing the next generation of respiratory medicines to patients."

The adverse event frequency was similar between benralizumab-treated
patients versus placebo-treated patients for both SIROCCO and CALIMA
(72% and 74% for all benralizumab treated patients vs. 76% and 78%
for placebo-treated patients observed in SIROCCO and CALIMA,
respectively). The most common (?5%) adverse events in
benralizumab-treated patients observed in SIROCCO were asthma,
nasopharyngitis, upper respiratory infection, headache, bronchitis,
sinusitis, influenza and pharyngitis; and in CALIMA were
nasopharyngitis, asthma, bronchitis, upper respiratory tract
infection, headache and sinusitis.

Severe uncontrolled asthma is a debilitating and potentially fatal
form of the disease, where patients experience frequent exacerbations
every year and have significant limitations on lung function and
quality of life. Uncontrolled asthma can lead to a dependence on oral
corticosteroids (OCS), with systemic steroid exposure leading to
serious and irreversible adverse effects.

Benralizumab is an anti-eosinophil monoclonal antibody that induces
direct, rapid and near-complete depletion of eosinophils, with an
onset of action within 24 hours as confirmed in early phase I/II
trials. Eosinophils are the biological effector cells that drive
inflammation and airway hyper-responsiveness in approximately 50% of
asthma patients, leading to frequent exacerbations, impaired lung
function and asthma symptoms.

The data from the SIROCCO and CALIMA trials will be included in
regulatory submissions for benralizumab that are planned for the US
and EU later in 2016.

- ENDS -


About Severe Asthma

Asthma currently affects the health and day-to-day lifestyles of 315
million individuals worldwide, and by 2020 will likely increase in
numbers to as many as 400 million people. Up to 10% of asthma cases
are severe, of which approximately 40% remain uncontrolled on current
standard of care medicine. Severe, uncontrolled asthma has an eight
times higher risk of mortality than severe asthma. Uncontrolled
asthma can lead to a dependence on OCS. Systemic steroid exposure can
lead to serious and irreversible adverse effects, including
osteoporosis, anxiety, depression, weight gain, glaucoma and
diabetes. There is also a significant physical and socio-economic
burden of severe asthma with these patients accounting for 50% of
asthma-related costs.

About the WINDWARD Programme

The WINDWARD programme in asthma is made up of six Phase III trials,
the largest Phase III development programme for a biologic medicine
in respiratory disease, evaluated a total of 3,068 patients in 798
sites across 26 countries.

The two pivotal trials, SIROCCO and CALIMA, are randomised,
double-blind, 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 2,511 patients (1,205 in SIROCCO and 1,306 in CALIMA)
currently receiving standard of care medicine (including high-dosage
inhaled corticosteroids and long-acting beta 2 agonists [ICS/LABA])
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 accessorized
pre-filled syringe.

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 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.

About AstraZeneca in Respiratory Disease

Respiratory disease is one of AstraZeneca's main therapy areas, and we
have a growing portfolio of medicines that reached more than 17
million patients in 2015. Our 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. We are building on a 40-year
heritage in respiratory disease, and our capability in inhalation
technology spans both pressurised metered-dose inhalers (pMDIs) and
dry powder inhalers (DPIs), as well as our unique
Co-SuspensionTMDelivery Technology. Our research is focused on three
key biological pathways: eosinophilic disease, Th2-driven disease and
epithelial-driven pathobiology.

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 - Respiratory and Autoimmunity, Cardiovascular
and Metabolic Diseases, and Oncology. The company is also active in
inflammation, infection and neuroscience through numerous
collaborations. AstraZeneca operates in over 100 countries and its
innovative medicines are used by millions of patients worldwide. For
more information please visit:


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