ASTRAZENECA AND BRISTOL-MYERS SQUIBB ANNOUNCE TOP-LINE RESULTS FOR SAVOR-TIMI-53 CARDIOVASCULAR OUTCOMES TRIAL OF ONGLYZA® (SAXAGLIPTIN)

19 June, 2013

AstraZeneca and Bristol-Myers Squibb announced today top-line results of the
Phase IV SAVOR-TIMI-53 (Saxagliptin Assessment of Vascular Outcomes Recorded in
Patients with Diabetes Mellitus) clinical trial of Onglyza ® (saxagliptin). In
this study of adult patients with type 2 diabetes with either a history of
established cardiovascular disease or multiple risk factors, Onglyza met the
primary safety objective of non inferiority, and did not meet the primary
efficacy objective of superiority, for a composite endpoint of cardiovascular
death, non-fatal myocardial infarction or non-fatal ischaemic stroke, when added
to a patient’s current standard of care (with or without other anti-diabetic
therapies), as compared to placebo.

These preliminary SAVOR-TIMI-53 data are being analysed and the study results
will be submitted to the European Society of Cardiology (ESC) for potential
presentation at the ESC Congress in September.

– ENDS –

NOTES TO EDITORS

About Onglyza® (saxagliptin)
Onglyza is indicated as an adjunct to diet and exercise to improve glycemic
(blood sugar) control in adults with type 2 diabetes mellitus in multiple
clinical settings. Onglyza should not be used for the treatment of patients with
type 1 diabetes mellitus or diabetic ketoacidosis (increased levels of ketones
in the blood or urine), as it would not be effective in these settings. Onglyza
has not been studied in patients with a history of pancreatitis.

Onglyza is contraindicated in patients with a history of a serious
hypersensitivity reaction to Onglyza (e.g., anaphylaxis, angioedema or
exfoliative skin conditions). There have been post-marketing reports of acute
pancreatitis and serious hypersensitivity reactions in patients taking Onglyza.
If pancreatitis or a serious hypersensitivity reaction is suspected, promptly
discontinue Onglyza and institute appropriate medical treatment. It is unknown
whether patients with a history of pancreatitis are at an increased risk for
development of pancreatitis while using Onglyza.

When Onglyza was used in combination with a sulfonylurea or with insulin (two
medications known to cause hypoglycemia), the incidence of confirmed
hypoglycemia was increased over that of placebo used in combination with a
sulfonylurea or with insulin. Therefore, a lower dose of the insulin
secretagogue or insulin may be required to minimize the risk of hypoglycemia
when used in combination with Onglyza.

As of June 2013, Onglyza has been submitted for regulatory review in 95
countries and is approved in 86 countries including those in the European Union,
the United States, Canada, Mexico, India, Brazil and China.

About SAVOR
SAVOR-TIMI-53 was a randomized, double-blind, placebo-controlled trial that
involved 16,500 patients in 25 countries with type 2 diabetes who had a history
of established cardiovascular disease or multiple risk factors, with or without
renal impairment. SAVOR was led by the academic research organizations TIMI
Study Group and Hadassah University Medical Center and conducted at over 700
sites worldwide.

About Bristol-Myers Squibb and AstraZeneca Collaboration
Dedicated to addressing the global burden of diabetes by advancing
individualized patient care, AstraZeneca and Bristol-Myers Squibb are working in
collaboration to research, develop and commercialize a versatile portfolio of
innovative treatment options for diabetes and related metabolic disorders that
aim to provide treatment effects beyond glucose control. Find out more about the
Alliance and our commitment to meeting the needs of health care professionals
and people with diabetes at www.astrazeneca.com or www.bms.com.

About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to
discover, develop and deliver innovative medicines that help patients prevail
over serious diseases. For more information, please visit http://www.bms.com or
follow us on Twitter at http://twitter.com/bmsnews.

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

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