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2015-09-02

AstraZeneca: Positive phase III results demonstrate efficacy of antibiotic medicine CAZ-AVI in complicated urinary tract infections

AstraZeneca today announced positive topline results from RECAPTURE 1
and RECAPTURE 2, the pivotal Phase III studies evaluating the
antibiotic, CAZ-AVI (ceftazidime-avibactam), as a treatment for adult
hospitalised patients with complicated Urinary Tract Infections
(cUTI), including pyelonephritis.

CAZ-AVI consists of a cephalosporin (ceftazidime), an established
treatment for serious bacterial infections, and a next generation
non-beta lactam beta-lactamase inhibitor (avibactam). CAZ-AVI is
being developed to treat a broad range of Gram-negative bacterial
infections which are becoming increasingly resistant to antibiotics
and pose a threat to public health. The addition of avibactam
protects ceftazidime from being broken down by beta-lactamases that
are produced by these resistant bacteria.

In the US, where AstraZeneca's partner Allergan holds the
commercialisation rights, CAZ-AVI (AVYCAZTM) was approved by the Food
and Drug Administration (FDA) in February 2015 for cUTI and
complicated intra-abdominal Infections (cIAI) for patients 18 years
of age and older who currently have limited or no alternative
treatment options, based on a previously submitted New Drug
Application with Phase II data. In the EU, where AstraZeneca holds
the commercialisation rights, the regulatory submission seeking
approval for a broad range of indications, was accepted and validated
by the European Medicines Agency (EMA) in May 2015 and is currently
under review.

The global RECAPTURE 1 and RECAPTURE 2 Phase III studies evaluated the
safety and efficacy of CAZ-AVI, administered intravenously as a
two-hour infusion (2000/500mg every 8 hours), compared to doripenem,
administered intravenously as a 30-minute infusion (500mg every 8
hours), in hospitalised adult patients with cUTI, including
pyelonephritis. Data from the studies were analysed as a
single-pooled dataset with the agreement of the US FDA and the EMA.

In the RECAPTURE 1 and RECAPTURE 2 Phase III studies, CAZ-AVI met the
objective of statistical non-inferiority compared to doripenem for
both the EMA primary and FDA co-primary endpoints. Additionally, for
the EMA primary endpoint, CAZ-AVI was statistically superior (at the
5% level) to doripenem.

CAZ-AVI was also effective in treating cUTI patients infected with
ceftazidime-resistant bacteria.

The most commonly reported adverse events were headache, nausea,
constipation and diarrhoea. No new safety concerns were identified
upon review of the most frequent events up to the late follow-up
visit (45-52 calendar days after randomisation).

Elisabeth Björk, Vice President, Global Medicines Development,
AstraZeneca, said: "These positive results show the efficacy of
CAZ-AVI in treating complicated urinary tract infections, including
those resistant to ceftazidime, and further support regulatory
submissions to make this medicine available to patients. AstraZeneca
is committed to addressing the public health challenge posed by
emerging infections through our portfolio of innovative antibiotics."

"We are very pleased by these results, which we plan to submit to the
FDA to further support the use of AVYCAZ as a treatment option for
patients with these serious and life-threatening complicated urinary
tract infections," said David Nicholson, Executive Vice President &
President, Global Brands R&D at Allergan.

The RECAPTURE data will be provided to the EMA as part of the
regulatory review process for the on-going CAZ-AVI Marketing
Authorisation Application.

- ENDS -

NOTES TO EDITORS

About RECAPTURE

RECAPTURE 1 and RECAPTURE 2 are Phase III, randomised, multi-centre,
double-blind, double-dummy, parallel-group, comparative studies to
determine the efficacy, safety, and tolerability of CAZ-AVI(2000 mg /
500 mg, q8h) versus doripenem (500mg, q8h) in the treatment of
complicated urinary tract infections in hospitalised adults. As
agreed with both the US FDA and the EMA, data from the RECAPTURE 1
and 2 studies have been analysed as single-pooled dataset. A total of
1033 patients have been randomised to the RECAPTURE1 and 2 trials
from 30 countries.

For the FDA, the co-primary analysis was conducted in the
Microbiological Modified Intent-to-Treat (mMITT) population and the
non-inferiority margin was 10%. The co-primary endpoints were

(1) Symptomatic resolution of UTI-specific symptoms except flank pain
(frequency/urgency/dysuria/suprapubic pain) and resolution of, or
improvement in, flank pain based on the patient-reported symptom
assessment response at the Day 5 visit and

(2) Proportion of patients with both a symptomatic resolution of
UTI-specific symptoms at Test of Cure (TOC) visit and a favourable
microbiological response at TOC.

The lower and upper bounds of the 95% confidence interval for the
difference (CAZ-AVI - doripenem) in the percentage of patients for
(1) were -2.39% and 10.42% respectively and for (2) were 0.30% and
13.12% respectively.

For the EMA, the primary analysis of Favourable microbiological
response was conducted at the TOC in the mMITT population and the
non-inferiority margin was 12.5%. The lower and upper bounds of the
95% confidence interval for the difference (CAZ-AVI - doripenem) in
the percentage of patients with a favourable microbiological response
were 0.3% and 12.4% respectively. This result shows statistical
superiority of CAZ-AVI with the lower limit of the 2-sided 95%
confidence interval for the treatment difference of 0.33 being above
zero.

The mMITT population included all enrolled patients who met the cUTI
diagnosis criteria and were identified as carrying an eligible
baseline pathogen.

About CAZ-AVI

CAZ-AVI is an antibiotic being developed to treat serious
Gram-negative bacterial infections. It consists of ceftazidime, a
third-generation, antipseudomonal cephalosporin, that is an
established and respected treatment for serious Gram-negative
bacterial infections, and avibactam, a next generation, non-β lactam
β-lactamase inhibitor.

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 Pseudomonas aeruginosa.

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

About ALLERGAN

Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a
unique, global pharmaceutical company and a leader in a new industry
model-Growth Pharma. Allergan is focused on developing,
manufacturing, and commercialising innovative branded
pharmaceuticals, high-quality generic and over-the-counter medicines,
and biologic products for patients around the world.

Allergan markets a portfolio of best-in-class products that provide
valuable treatments for the central nervous system, eye care, medical
aesthetics, gastroenterology, women's health, urology, cardiovascular
and anti-infective therapeutic categories, and operates the world's
third-largest global generics business, providing patients around the
globe with increased access to affordable, high-quality medicines.
Allergan is an industry leader in research and development, with one
of the broadest development pipelines in the pharmaceutical industry
and a leading position in the submission of generic product
applications globally.

With commercial operations in approximately 100 countries, Allergan is
committed to working with physicians, health care providers, and
patients to deliver innovative and meaningful treatments that help
people around the world live longer, healthier lives.

For more information, visit Allergan's website at www.allergan.com.

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
cardiovascular, metabolic, respiratory, inflammation, autoimmune,
oncology, infection and neuroscience diseases. 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
Esra Erkal-Paler UK/Global +44 20 7604 8030
Vanessa Rhodes UK/Global +44 20 7604 8037
Ayesha Bharmal UK/Global +44 20 7604 8034
Karen Birmingham UK/Global +44 20 7604 8120
Jacob Lund Sweden +46 8 553 260 20
Michele Meixell US +1 302 885 2677
Investor Enquiries
UK
Thomas Kudsk Larsen +44 20 7604 8199 +44 7818 524185
Eugenia Litz RIA +44 20 7604 8233 +44 7884 735627
Nick Stone CVMD +44 20 7604 8236 +44 7717 618834
Karl Hård Oncology +44 20 7604 8123 +44 7789 654364
Craig Marks ING +44 20 7604 8591 +44 7881 615764
Christer Gruvris +44 20 7604 8126 +44 7827 836825
US
Lindsey Trickett ING +1 301 398 5118 +1 301 398 5118
Dial / Toll-Free +1 301 398 3251 +1 866 381 7277

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

ING - Infection, Neuroscience and Gastrointestinal

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Författare WKR

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