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AstraZeneca Submits NDA for Low Dose Aspirin/Esomeprazole Combination Product
Date:5/4/2009

- Company Also Submits sNDA for NEXIUM Capsules for Risk Reduction of Low-Dose Aspirin-Associated Peptic Ulcer -

WILMINGTON, Del., May 4 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE: AZN) today announced the submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for a product combining low dose aspirin with esomeprazole magnesium for the risk reduction of low dose aspirin-associated gastric and/or duodenal ulcers in patients at risk.

AstraZeneca also submitted a supplemental new drug application (sNDA) for NEXIUM(R) (esomeprazole magnesium) for the risk reduction of low dose aspirin-associated gastric and/or duodenal ulcers. NEXIUM already is approved for the risk reduction in the occurrence of gastric ulcers associated with continuous non-steroidal anti-inflammatory drug (NSAID) therapy in patients at risk for developing gastric ulcers.(1)

Low-dose aspirin is the mainstay in the prevention of cardio- and cerebrovascular events such as heart attack and stroke.(2A,3A) However, even at low doses, aspirin is associated with a risk of peptic ulcers and gastrointestinal symptoms.(3B,3C) These gastrointestinal side effects can lead patients to discontinue their aspirin therapy.(3D,3E) Discontinuation due to GI problems is associated with a three-fold higher risk of major CV events,(4A) which can occur within just 1-2 weeks of discontinuation.(4B) Up to 1 in 3 patients on low-dose ASA may develop upper GI symptoms.(5A,6A)

AstraZeneca conducted two studies to evaluate the safety and efficacy of NEXIUM in reducing the risk of gastric and/or duodenal ulcers in patients who take low dose aspirin (75-325 mg continuously during the study, which is defined as at least 5 days per week). One study compared NEXIUM 40 mg or 20 mg with placebo, while the other study compared NEXIUM 20 mg with placebo. Both the NDA and sNDA submissions are based on the results of these studies.

About NEXIUM(R) (esomeprazole magnesium)

NEXIUM 20 mg is indicated to maintain symptom resolution and healing of EE (controlled studies did not extend beyond 6 months), and for treatment of heartburn and other symptoms associated with GERD. NEXIUM 40 mg and 20 mg daily are indicated for short-term treatment (4 to 8 weeks) in healing and symptomatic resolution of diagnostically confirmed erosive esophagitis (EE).

NEXIUM should be used only for the conditions, dosages, and durations specified in the Prescribing Information. For more information visit www.NEXIUM-US.com.

IMPORTANT SAFETY INFORMATION

NEXIUM is contraindicated in patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles.

The most frequently reported adverse events with NEXIUM include headache, diarrhea, and abdominal pain. Symptomatic response to therapy does not preclude the presence of gastric malignancy.

Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with omeprazole, of which NEXIUM is an enantiomer.

As with all PPIs, patients treated concomitantly with warfarin may need to be monitored for increases in INR and prothrombin time. Like other proton pump inhibitors, esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g., ketoconazole, iron salts, and digoxin).

Concomitant use of NEXIUM and atazanavir or nelfinavir is not recommended because the plasma concentrations and therapeutic effects of those antiretroviral drugs may be reduced.

NEXIUM may increase the plasma levels of saquinavir. Dose reduction of saquinavir should be considered.

Please see full Prescribing Information for NEXIUM.

For additional information, questions, or to request a copy of the NEXIUM prescribing information, please contact the Information Center at AstraZeneca at 1-800-236-9933, Monday through Friday, from 8 a.m. to 6 p.m. ET, excluding holidays.

About AstraZeneca

AstraZeneca is engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and in the supply of healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with global healthcare sales of $31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. In the United States, AstraZeneca is a $13.5 billion dollar healthcare business. For more information about AstraZeneca in the US or our AZ&Me(TM) Prescription Savings programs, please visit: www.astrazeneca-us.com.

References:

  1. Prescribing Information for NEXIUM. Indications and Usage section.
  2. Antithrombotic Trialists' Collaboration. Collaborative Meta-Analysis of Randomised Trials of Antiplatelet Therapy for Prevention of Death, Myocardial Infarction, and Stroke in High Risk Patients. BMJ. 2002;324:71-86.
  3. U.S. Preventative Services Task Force. Aspirin for the Prevention of Cardiovascular Disease: U.S. Preventive Services Task Force Recommendation Statement. Annals of Internal Medicine. 2009;150;396-404.
  4. Giuseppe G.L., Biondi-Zoccai, et al. A Systematic Review and Meta-Analysis on the Hazards of Discontinuing Or Not Adhering to Aspirin Among 50 279 Patients at Risk for Coronary Artery Disease. European Heart Journal. 2006;27:2667-2674.
  5. CAPRIE Steering Committee. A Randomised, Blinded, Trial of Clopidogrel Versus Aspirin in Patients at Risk of Ischaemic Events (CAPRIE).The Lancet. 1996;348:1329-39.
  6. Thiefin Gerard, Gilles Montalescot, et al. Prevalence and Clinical Impact of Upper Gastrointestinal Symptoms in Patients Treated with Low-Dose Aspirin. W1924 DDM. 2008.


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SOURCE AstraZeneca
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