FDA concludes no increased risk of cardiac events for patients treated with omeprazole and Nexium

Dec 10 2007

The US Food and Drug Administration (FDA) has issued its final assessment of two small, open, long-term, clinical studies in patients with gastro-esophageal reflux disease (GERD), comparing anti-reflux surgery with either omeprazole (SOPRAN study) or NEXIUM (LOTUS study) treatment.

AstraZeneca agrees with the FDA conclusion which states "FDA continues to conclude that long-term use of these drugs is not likely to be associated with an increased risk of heart problems. FDA recommends that health care providers continue to prescribe, and patients continue to use, these products as described in the labeling for the two drugs." AstraZeneca also supports the conclusion made by the FDA that the overall benefit/risk profiles of omeprazole and NEXIUM remain unchanged. AstraZeneca continues to be confident in the safety profiles of omeprazole and NEXIUM.

The conclusion confirms the public announcement made on August 9, 2007 when the FDA stated that preliminary evaluation of the SOPRAN and LOTUS data does not suggest an increased risk of cardiac events for patients treated with omeprazole or NEXIUM. This announcement was in response to a communication sent to worldwide Health Authorities by AstraZeneca in May 2007 regarding the SOPRAN and LOTUS studies.

PRILOSEC(R)/LOSEC (omeprazole)(*) was first launched outside the US in 1988 and in the US in 1989. NEXIUM was first launched outside the US in 2000 and in the US in 2001. Proton Pump Inhibitors (PPIs) have been shown to be beneficial for patients with gastroesophageal reflux disease (GERD). PPIs are generally well tolerated and PRILOSEC/LOSEC and NEXIUM have been used in the management of GERD in over 1 billion patient treatments.

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

In the United States, AstraZeneca is a $12.44 billion healthcare business with more than 12,000 employees. For nearly three decades, AstraZeneca has offered drug assistance programs side by side with its medicines, and over the past five years, has provided over $3 billion in savings to more than 1 million patients throughout the US and Puerto Rico. AstraZeneca has been named one of the "100 Best Companies for Working Mothers" by Working Mother magazine and is the only large pharmaceutical company named to FORTUNE magazine's 2007 list of "100 Best Companies to Work For." In 2006, for the fifth consecutive year, Science magazine named AstraZeneca a "Top Employer" on its ranking of the world's most respected biopharmaceutical employers.

NEXIUM, launched in the U.S. in 2001, is approved for the treatment of heartburn and other symptoms associated with GERD, as well as for the short- term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 week course of NEXIUM may be considered. NEXIUM is indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months.

Common side effects with NEXIUM include headache, diarrhea, and abdominal pain. Symptom relief does not rule out other serious stomach conditions.

AstraZeneca is committed to helping people get the medicines they need. In 2006, 97,614 NEXIUM patients were provided patient assistance through AstraZeneca programs, which equates to patient savings of $105M. Nationwide, the majority of people with prescription coverage can get NEXIUM for less than a dollar a day, based on national average co-pay. Individual costs may vary.

For more information about NEXIUM, including the US Prescribing Information please visit: www.NEXIUM-us.com.

PRILOSEC, launched in the U.S. in 1989, was the first in a class of medications called proton pump inhibitors (PPIs) that block acid production by inhibiting an enzyme system (hydrogen-potassium ATPase) on the surface of the stomach's parietal cells.

PRILOSEC is indicated for the treatment of heartburn and other symptoms associated with gastroesophageal reflux disease. PRILOSEC is also indicated for the short-term treatment (4 to 8 weeks) of erosive esophagitis that has been diagnosed by endoscopy.

The efficacy of PRILOSEC used for longer than 8 weeks in these patients has not been established. If there is recurrence of erosive esophagitis or GERD symptoms (e.g., heartburn), additional 4 to 8 weeks courses of omeprazole may be considered. PRILOSEC is also indicated to maintain healing of erosive esophagitis. Controlled studies do not extend beyond 12 months.

Common side effects with PRILOSEC include headache, diarrhea, and abdominal pain. Symptom relief does not rule out other serious stomach conditions.