POSITIVE CHMP OPINION FOR CAZ AVI

POSITIVE CHMP OPINION FOR CAZ AVI IN THE EU FOR SERIOUS BACTERIAL INFECTIONS

AstraZeneca today announced that the Committee for Medicinal Products for Human
Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion,
recommending the approval of a new antibiotic, CAZ AVI 2g/0.5g powder.

CAZ AVI is being developed to treat a broad range of Gram-negative bacterial
infections that are increasingly resistant to antibiotics, including multi-drug
resistant P. aeruginosa, carbapenem-resistant Gram-negative pathogens, and ESBL
-producing Enterobacteriaceae. Increasing antibiotic resistance in Gram-negative
bacteria is a growing public health concern because of the limited new treatment
options for these serious infections. In Europe, Gram-negative bacteria are
responsible for two thirds of the annually reported 25,000 deaths resulting from
antimicrobial resistance.1

The recommendation is for intravenous use in the treatment of adult patients
with complicated intra-abdominal infection (cIAI), complicated urinary tract
infection (cUTI) including pyelonephritis, and hospital-acquired pneumonia
(HAP), including ventilator associated pneumonia (VAP). The CHMP also
recommended that CAZ AVI be indicated for the treatment of infections caused by
aerobic Gram-negative organisms in adult patients who have limited treatment
options.

The CHMP's positive opinion is based on a review of data from an extensive
clinical trial programme demonstrating the safety and efficacy of CAZ AVI. The
submission included data from three Phase III studies in cIAI; Phase II and III
studies in cUTI; and data from a Phase I study for HAP/VAP. An additional Phase
III study, which evaluated the efficacy of CAZ AVI in ceftazidime-resistant cUTI
and cIAI compared to the best available therapy, was also included for
consideration.

The CHMP's positive opinion on CAZ AVI will now be reviewed by the European
Commission (EC), which has the authority to approve medicines for the European
Union (EU). The final decision by the EC is expected in the coming months and
will be applicable to all 28 EU member countries plus Iceland, Norway and
Liechtenstein.

CAZ AVI is being jointly developed by AstraZeneca and Allergan. AstraZeneca
holds the global rights to commercialise ceftazidime-avibactam, with the
exception of North America, where the rights are held by Allergan.

About CAZ AVI CAZ AVI is an investigational antibiotic being developed to treat
serious Gram-negative bacterial infections. It consists of a combination of
avibactam and ceftazidime - a third generation antipseudomonal cephalosporin
with a well-established efficacy and safety profile. Avibactam is a first-in
-class broad-spectrum β-lactamase inhibitor, which protects ceftazidime against
degradation by Class A, C and some D, β-lactamases.

The addition of avibactam to ceftazidime protects ceftazidime from breakdown by
β-lactamases. CAZ AVI offers a differentiated profile versus existing treatment
options in serious Gram-negative infections through its coverage of a broad
range of species of Enterobacteriaceae including those that produce ESBL and KPC
together with activity against difficult to treat P. aeruginosa.

About Complicated Intra-abdominal Infection (cIAI)

Most intra-abdominal infections (IAI) are a result of processes involving
inflammation and perforations of the gastrointestinal tract, such as
appendicitis, peptic ulcer disease, and diverticulitis (a common digestive
disease which involves the formation of pouches within the bowel wall). IAI is
an important cause of morbidity and mortality. In fact, it is the second most
commonly identified cause of severe sepsis in the intensive care unit (ICU).

About Complicated Urinary Tract Infection (cUTI)

Complicated urinary tract infections (cUTI) are defined as a clinical syndrome
characterized by pyuria and a documented microbial pathogen on culture of urine
or blood. Patients usually present with symptoms including fever, chills,
malaise, flank pain, back pain, and/or costo-vertebral angle pain or tenderness,
that occur in the presence of a functional or anatomical abnormality of the
urinary tract or in the presence of catheterization.

About Hospital Acquired Pneumonia (HAP) including Ventilator Associated
Pneumonia (VAP)

Hospital-acquired pneumonia (HAP) refers to the development of lung infections
after a patient has been hospitalised for a minimum of 48 hours. If, after 48
hours the infection develops despite the use of intubation and mechanical
ventilation, the condition is then called Ventilator associated Pneumonia (VAP).

VAP is generally a severe illness, with patients requiring treatment in the
intensive care unit (ICU). Some non-intubated patients with HAP can have either
mild or more severe pneumonia.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that
focuses on the discovery, development and commercialisation of prescription
medicines, primarily for the treatment of diseases in three main therapy areas -
respiratory, inflammation, autoimmune disease (RIA), cardiovascular and
metabolic disease (CVMD) and oncology - as well as in infection and
neuroscience. 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
Neil Burrows         UK/Global            +44 20 7604 8032
Vanessa Rhodes       UK/Global            +44 20 7604 8037
Karen Birmingham     UK/Global            +44 20 7604 8120
Jacob Lund           Sweden               +46 8 553 260 20
Abigail Bozarth      US                   +1 302 885 2677
Investor Enquiries
UK
Thomas Kudsk Larsen   UK                  +44 7818 524185
Eugenia Litz         RIA                  +44 7884 735627
Nick Stone           CVMD                 +44 7717 618834
Craig Marks          Finance              +44 7881 615764
Christer Gruvris     Consensus Forecasts  +44 7827 836825
US
Lindsey Trickett     Oncology, ING        +1 240 543 7970
Mitch Chan           Oncology             +1 240 477 3771
Dial / Toll-Free                          +1 866 381 7277

Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and
Metabolic Disease,

ING - Infection, Neuroscience and Gastrointestinal

References

1. European Centre for Disease Prevention and Control (ECDC). Technical Report:
the bacterial challenge: time to react. Available at:
http://www.ema.europa.eu/docs/en_GB/document_library/Report/2009/11/WC500008770.
p 
df accessed April 2016.

29 April 2016

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