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AstraZeneca plc : AstraZeneca and Bristol-Myers Squibb resubmit dapagliflozin New Drug Application for the treatment of type 2 diabetes in the U.S

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07/25/2013 | 02:26pm CEST

AstraZeneca and Bristol-Myers Squibb today announced they have resubmitted to the U.S. Food and Drug Administration (FDA), a New Drug Application (NDA) for dapagliflozin for the treatment of adults with type 2 diabetes.

The NDA resubmission, which is pending acceptance by the FDA, includes several new studies and additional long-term data (up to four years' duration) from previously submitted studies.

NOTES TO EDITORS About dapagliflozin

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.

About Type 2 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 characterised 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.

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.www.astrazeneca.com

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Financials ($)
Sales 2018 22 568 M
EBIT 2018 5 551 M
Net income 2018 1 898 M
Debt 2018 14 767 M
Yield 2018 3,96%
P/E ratio 2018 38,31
P/E ratio 2019 29,29
EV / Sales 2018 4,63x
EV / Sales 2019 4,39x
Capitalization 89 830 M
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Spread / Average Target 7,2%
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Pascal Soriot Chief Executive Officer & Executive Director
Leif Valdemar Johansson Non-Executive Chairman
Pam P. Cheng Executive VP-Operations & Information Technology
Marc Dunoyer Chief Financial Officer & Executive Director
Sean Bohen Chief Medical Officer & Executive Vice President
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