FDA ACKNOWLEDGES RECEIPT OF RESUBMISSION OF THE NEW DRUG APPLICATION FOR INVESTIGATIONAL COMPOUND DAPAGLIFLOZIN FOR THE TREATMENT OF TYPE 2 DIABETES


AstraZeneca and Bristol-Myers Squibb Company today announced that the U.S. Food
and Drug Administration (FDA) has acknowledged receipt of the New Drug
Application (NDA) resubmission for investigational drug dapagliflozin for the
treatment of adults with type 2 diabetes. The FDA assigned a new Prescription
Drug User Fee Act goal date of January 11 2014.

The dapagliflozin Phase II/III clinical development program included more than
12,000 adult patients with diabetes (more than 8,000 patients received
dapagliflozin) in 26 clinical trials. In response to the FDA’s January 2012
complete response letter requesting additional data to allow a better assessment
of the benefit-risk profile of dapagliflozin, the NDA resubmission includes
several new studies and additional long-term data (up to four years’ duration)
from previously submitted studies, resulting in an overall increase in patient
-years exposure to dapagliflozin of more than 50 percent.

Dapagliflozin, an investigational compound, is a selective and reversible
inhibitor of sodium-glucose cotransporter 2 (SGLT2), which works independently
of insulin. It is currently approved for the treatment of type 2 diabetes in the
European Union, Australia, Brazil, Mexico and New Zealand.

– ENDS –

NOTES TO EDITORS

About SGLT2 Inhibition
The kidney plays an important role in maintaining normal glucose balance by
filtering and reabsorbing glucose from circulation. SGLT2, a sodium-glucose
cotransporter found predominantly in the kidney, is responsible for
approximately 90% of glucose reabsorption. In patients with type 2 diabetes, the
capacity of the kidney to reabsorb glucose is increased by approximately 20%,
further exacerbating the hyperglycemia associated with the disease. Selective
inhibition of SGLT2 reduces the reabsorption of excess glucose and enables its
removal via the urine.

About Diabetes
In 2012, diabetes was estimated to affect more than 370 million people
worldwide. The prevalence of diabetes is projected to reach more than 550
million by 2030. Type 2 diabetes accounts for approximately 90% to 95% of all
cases of diagnosed diabetes in adults. Type 2 diabetes is a chronic disease
characterized by insulin resistance and dysfunction of beta cells in the
pancreas, leading to elevated glucose levels. Over time, this sustained
hyperglycemia contributes to further progression of the disease. Significant
unmet needs still exist, as many patients remain inadequately controlled on
their current glucose-lowering regimen.

AstraZeneca/Bristol-Myers Squibb Diabetes Alliance
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 commercialise 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 http://www.astrazeneca.com or www.bms.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.

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 about Bristol-Myers Squibb, visit
http://www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.

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