FDA REVIEWS SAVOR OUTCOMES STUDY RESULTS

FDA ADVISORY COMMITTEE REVIEWS SAVOR OUTCOMES STUDY RESULTS FOR ONGLYZA®
(SAXAGLIPTIN) AND KOMBIGLYZE® XR (SAXAGLIPTIN AND METFORMIN HCI EXTENDED
-RELEASE)

AstraZeneca today announced that the US Food and Drug Administration (FDA)
Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 13to 1 (1
abstained; 15 total votes) that the results of the Saxagliptin Assessment of
Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR) study
demonstrated that the use of saxagliptin in patients with type 2 diabetes has an
acceptable cardiovascular risk profile. In addition, 14 out of 15 Committee
members recommended that the FDA supplement the products' labeling to add new
safety information, with one vote to withdraw saxagliptin from the market.

AstraZeneca will also conduct further investigation to better understand the
signal of hospitalisation for heart failure found in the SAVOR results.

The Advisory Committee was asked to consider data from SAVOR, a large,
randomised, double-blind, placebo-controlled postmarketing study designed to
evaluate the cardiovascular effects of ONGLYZA when added to current type 2
diabetes background therapy in adult patients with type 2 diabetes mellitus at
risk for cardiovascular disease.

SAVOR met the primary safety objective, demonstrating that ONGLYZA did not
increase the risk for cardiovascular death, nonfatal myocardial infarction and
nonfatal ischemic stroke when added to a patient's current standard of care,
with or without other antidiabetic therapies, as compared to placebo. The
supplemental New Drug Applications (sNDAs) based on the SAVOR results, if
approved, will provide prescribers and patients important additional information
about the benefit-risk profile of ONGLYZA and KOMBIGLYZEXR.

The Advisory Committee was convened to discuss previously submitted sNDAs to the
FDA for ONGLYZA and KOMBIGLYZE XR. The FDA is not bound by the Advisory
Committee's recommendation but takes its advice into consideration when
reviewing these sNDAs. AstraZeneca remains committed to working closely with the
FDA to support further review of these sNDAs.

About SAVOR

The SAVOR (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with
Diabetes Mellitus) clinical trial of ONGLYZA (saxagliptin) was a large,
randomised, double-blind, placebo-controlled Phase IV study in patients with
type 2 diabetes at high risk of cardiovascular disease, designed and conducted
in accordance with the 2008 FDA guidance, "Diabetes Mellitus - Evaluating
Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes." The
primary objective of this trial was to determine that the addition of
saxagliptin to standard of care in this patient population did not significantly
increase the incidence of major cardiovascular events as compared to placebo.

SAVOR met the primary safety objective, demonstrating that ONGLYZA did not
increase the risk for cardiovascular death, nonfatal MI and nonfatal ischaemic
stroke when added to a patient's current standard of care (with or without other
antidiabetic therapies), as compared to placebo (613 patients [3.7 per 100
person-years] in the ONGLYZA group compared with 609 patients [3.7 per 100
person-years] in the placebo group (Hazard Ratio [HR]: 1.00; 95% Confidence
Interval [CI]: 0.89, 1.12; non-inferiority p-value < 0.001; superiority p-value
= 0.99]). ONGLYZA did not meet the primary efficacy objective of superiority to
placebo for the same composite endpoint. For the secondary endpoint of nonfatal
MI, nonfatal stroke, cardiovascular death, hospitalisation for heart failure
(hHF), hospitalisation for unstable angina, or hospitalisation for coronary
revascularization, no statistically significant treatment differences were
observed between ONGLYZA and placebo (HR 1.02 [95% CI 0.94, 1.11]; nominal
p=0.66 for a difference between the 2 treatment groups). However, an increased
risk for hHF, a component of the balanced secondary endpoint, was observed with
ONGLYZA treatment. The analysis showed a numerical imbalance with more events on
ONGLYZA (HR 1.11 [95% CI 0.96, 1.27]; nominal p=0.154). This finding was most
relevant for patients at increased risk for heart failure (HF), such as those
with a history of HF or renal impairment, and is manageable in the context of
the routine care of patients at risk for HF. The other secondary endpoint of the
SAVOR study was all-cause mortality. The analysis showed a numerical imbalance
with more events on ONGLYZA (HR 1.11 [95% CI 0.96, 1.27]; nominal p=0.154). The
results of the evaluation of all-cause mortality indicate that there was no
excess mortality attributable to saxagliptin in the SAVOR study.

About DPP-4 inhibitors

Saxagliptin belongs to the class of dipeptidyl peptidase-4 (DPP-4) inhibitors.
Incretin hormones decrease elevated blood sugar levels (glucose) by increasing
the body's utilisation of sugar, mainly through increasing insulin production in
the pancreas, and by reducing the liver's production of glucose. DPP-4
inhibitors work by increasing the activity of the incretin hormones, increasing
the release of insulin when glucose levels are elevated and reducing the levels
of sugar produced by the liver.

About Type 2 Diabetes

Diabetes is estimated to affect 29.1 million people in the US and more than 382
million people worldwide. The prevalence of diabetes is projected to reach more
than 592 million people worldwide by 2035. Type 2 diabetes accounts for
approximately 90-95 percent of all cases of diagnosed diabetes in the US. Type 2
diabetes is a chronic disease characterised by pathophysiologic defects leading
to elevated glucose levels. Significant unmet needs still exist, as many
patients remain inadequately controlled on their current glucose-lowering
regimen. It is estimated that more than half of people living with type 2
diabetes are not achieving recommended HbA1c goals based on guidelines
established by professional societies and advocacy organisations for diabetes
management.

About AstraZeneca in Diabetes

AstraZeneca is pushing the boundaries of science to create life-changing
medicines to reduce the burden and complications of diabetes. Our comprehensive
diabetes portfolio provides treatment options to patients throughout the
different stage of their disease, supporting them to reach treatment goals with
a mono or combination therapies.As a core strategic area for the company, we are
focusing our research and development efforts in diverse populations and
patients with significant co-morbidities, such as cardiovascular disease, heart
failure, obesity, NASH, and chronic kidney disease. Our research efforts are
also targeting the regeneration of pancreatic cells aiming to address the
underlying cause of the disease. In partnership with diabetes professional and
patient societies and associations, AstraZeneca is contributing to solutions
supporting prevention, awareness, diagnosis, professional education and advance
care for diabetic patients.

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                     +44 20 7604 8030 (UK/Global)
Vanessa Rhodes                    +44 20 7604 8037 (UK/Global)
Ayesha Bharmal                     +44 20 7604 8034 (UK/Global)
Jacob Lund                             +46 8 553 260 20 (Sweden)

Michele Meixell                        +1 302 885 6351 (US)

Investor Enquiries

Thomas Kudsk Larsen            +44 20 7604 8199       mob: +44 7818 524185
Karl Hård                                 +44 20 7604 8123    mob: +44 7789
654364
Eugenia Litz                            +44 20 7604 8233       mob: +44 7884
735627
Craig Marks                             +44 20 7604 8591       mob: +44 7881
615764

Christer Gruvris                       +44 20 7604 8126       mob: +44 7827
836825

15 April 2015

-ENDS-