ASTRAZENECA PLC ANNOUNCES NEW ANTIBIOTIC ZAVICEFTA APPROVED IN THE EUROPEAN UNION FOR PATIENTS WITH SERIOUS BACTERIAL INFECTIONS

28 June 2016

AstraZeneca today announced that the European Commission (EC) has granted
marketing authorisation for Zavicefta (ceftazidime-avibactam, previously known
as CAZ AVI), a new combination antibiotic for the treatment of patients with
serious Gram-negative bacterial infections requiring hospitalisation.

The approval includes intravenous use of Zavicefta for the treatment of adult
patients suffering from complicated intra-abdominal infections (cIAI);
Complicated urinary tract infections (cUTI), including pyelonephritis; hospital
-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP); and,
the treatment of aerobic Gram-negative infections in adult patients who have
limited treatment options.

Zavicefta has been developed in response to the urgent need for new antibiotics
to treat serious infections that are becoming increasingly resistant, such as
multi-drug resistant P. aeruginosa, carbapenem-resistant Gram-negative
pathogens, and ESBL-producing Enterobacteriaceae.

Hans Sijbesma, Managing Director, AstraZeneca Antibiotics Business Unit, said:
"Zavicefta is an important addition to the arsenal of antibiotics in the global
fight against antimicrobial resistance. Effective treatment options are rapidly
running out for serious Gram-negative infections. Zavicefta helps bridge that
gap and allows a broad population of patients across Europe to benefit from this
new medicine."

The approval is based on data from an extensive clinical trial programme
demonstrating the safety and efficacy of Zavicefta. The data include results
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 evaluating the
efficacy of Zavicefta in ceftazidime-resistant cUTI and cIAI, compared to the
best available therapy, was also included in the submission.

The EC marketing authorisation applies to all 28 EU member countries plus
Iceland, Norway and Liechtenstein.

About Zavicefta
Zavicefta (ceftazidime-avibactam) is a combination antibiotic that has been
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. Zavicefta 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.

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

About Antimicrobial Resistance
The increasing resistance to antibiotics is a growing public health concern
because of the limited treatment options available for these serious infections.
In Europe, antimicrobial resistance causes approximately 25,000 deaths every
year, and two-thirds of these deaths are estimated to be due to resistant Gram
-negative bacteria1. The clinical burden associated with antimicrobial
resistance is estimated to cost Europe approximately €1.5 billion per year1. At
present, 700,000 deaths are estimated to be attributed to antimicrobial
resistance globally.2

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
characterised 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 catheterisation.

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 during 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

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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.

2. Review on AMR, Antimicrobial resistance: Tackling a crisis for the health and
wealth of nations, 2014.

28 June 2016

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