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4-Traders Homepage  >  Equities  >  London Stock Exchange  >  AstraZeneca plc    AZN   GB0009895292

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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

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)
Michele Meixell +1 302 885 2677 (US)
Jacob Lund +46 8 553 260 20 (Sweden)

Colleen Proctor + 44 207 604 8128 mob: +1 302 357 4882
Ed Seage + 44 207 604 8125 mob: +1 302 373 1361

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Financials ($)
Sales 2017 21 460 M
EBIT 2017 5 837 M
Net income 2017 2 646 M
Debt 2017 12 099 M
Yield 2017 4,48%
P/E ratio 2017 28,14
P/E ratio 2018 22,96
EV / Sales 2017 4,20x
EV / Sales 2018 4,06x
Capitalization 78 041 M
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Mean consensus OUTPERFORM
Number of Analysts 34
Average target price 63,5 $
Spread / Average Target 3,0%
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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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