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Biopharmaceuticals Gastroenterology

 News Release - December 19, 2008

AstraZeneca Submits sNDA for NEXIUM(R) for the Short-Term Treatment of GERD in Infants 0 to 1 Year Old

Filing also includes age appropriate formulation of 2.5 mg and 5 mg strengths of NEXIUM for Delayed-Release Oral Suspension

WILMINGTON, Del., Dec. 19 (Healthcare Sales & Marketing Network) -- AstraZeneca (NYSE: AZN ) today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for NEXIUM® (esomeprazole magnesium) to seek approval for the short-term (up to 6 weeks) treatment of gastroesophageal reflux disease (GERD) in pediatric patients ages 0 to 1 year old.

GERD is a condition in which the contents of the stomach back up into the esophagus. Though it is often associated with adults, GERD also affects approximately 7 million children in the United States, causing symptoms such as pain, irritability, constant or sudden crying and frequent vomiting.(1) Although physiologic non-painful regurgitation is normal in the first year of life, a proportion of these infants may have persistent symptoms diagnosed as GERD that could require treatment with an acid-suppressive drug to help resolve the problem.(2)

NEXIUM is in a class of drugs known as proton pump inhibitors (PPIs) and was approved by the FDA for the short-term treatment of GERD in adolescents 12 to 17 years old in April 2006, and in children 1 to 11 years old in February 2008.

"An important medical need exists in infants younger than 1 year old, which is an often overlooked GERD population," said Marta Illueca, MD, FAAP, NEXIUM Brand Medical Director, AstraZeneca Pharmaceuticals, LP, U.S. "While some reflux and regurgitation are normal in infants and may not require medical treatment, persistent GERD symptoms can be very uncomfortable and cause damage to the esophagus, just as they can in older patients. Close medical supervision is key in the appropriate diagnosis and choice of treatment for these infants."

To ensure age-appropriate dosing and administration for the 0 to 1 year old patient population, AstraZeneca also filed for approval of 2.5 mg and 5 mg strengths of NEXIUM® (esomeprazole magnesium) for Delayed-Release Oral Suspension. This granular formulation, which is mixed with water to form a suspension that is administered orally or via feeding tubes, is currently available by prescription in 10 mg, 20 mg and 40 mg strengths. The formulation contains esomeprazole magnesium, the same active ingredient used in NEXIUM Delayed-Release Capsules.

The sNDA submission for NEXIUM in infants ages 0 to 1 year old is based on 3 studies performed in 167 infants ages 0 to 11 months. The first two studies provided data about the clinical pharmacology of NEXIUM in these young infants. The third study looked at the safety and effectiveness of NEXIUM in infants with various clinical manifestations of GERD. In this study, NEXIUM was well tolerated in these age groups and no new safety signals were detected.

For first-line treatment of pediatric GERD, families are encouraged to try lifestyle modifications, such as smaller, more frequent meals or dietary changes. If these methods fail, physicians at present have very few approved pharmacological options. At the time of this submission, no PPI is FDA approved for the treatment of GERD in infants younger than 1 year old.

About GERD

Approximately 60 million American adults experience gastroesophageal reflux disease (GERD) symptoms more than twice a week.(3) GERD is characterized by frequent and persistent heartburn, which occurs when the lower esophageal sphincter (the valve separating the esophagus and stomach) does not close properly, allowing acid to back up into the esophagus. GERD is chronic and, if left untreated, may potentially lead to more serious medical conditions such as erosive esophagitis.

The exact prevalence and frequency of GERD in children is unknown, as there are very few medical studies reporting the incidence of GERD symptoms in children. One study, a cross-sectional survey, looked at the prevalence of regurgitation in healthy infants 13 months old and younger. The study included a total of 948 parents of infants 13 months old and younger. Peak regurgitation was reported 23% of the time at 6 months. A proportion of these infants may have persistent symptoms diagnosed as GERD.(2) Close medical supervision is key in the proper diagnosis and choice of treatment for these infants.

About NEXIUM® (esomeprazole magnesium)

In adults, NEXIUM is approved for treating frequent, persistent heartburn and other symptoms associated with acid reflux disease as well as healing erosive esophagitis. Most erosions heal in four to eight weeks. Individual results may vary, and only a doctor can determine if erosions to the esophagus have occurred. Symptom relief does not rule out the existence of other serious stomach conditions.

NEXIUM was approved in April 2006 for the short-term treatment (up to 8 weeks) of GERD in adolescent patients 12 to 17 years old. NEXIUM was also approved for the short-term treatment (up to 8 weeks) of GERD in children 1 to 11 years old in February 2008. The approvals are supported by extrapolation of results from adequate and well-controlled studies that supported the approval of NEXIUM for adults, and safety and pharmacokinetic studies. The safety and effectiveness of NEXIUM for other pediatric uses other than GERD have not been established.

In adults, the most frequently reported adverse reactions with NEXIUM include headache, diarrhea, and abdominal pain. In patients 1 to 17 years of age, the most frequently reported adverse reactions with NEXIUM include headache, diarrhea, abdominal pain, nausea, and sleepiness. Symptomatic response to therapy does not preclude the presence of gastric malignancy. NEXIUM should be used only for the conditions, dosages, and durations specified in the Prescribing Information.

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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 a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. In the United States, AstraZeneca is a $13.35 billion healthcare business with 12,200 employees committed to improving people's lives. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

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(1) Pediatric/Adolescent Gastroesophageal Reflux Association (PAGER) Web site.

(2) North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) Pediatric GE Reflux Clinical Practice Guidelines. J Pediatr Gastroenterol Nutr, 2001;32:S1-S31.

(3) Shaker R, Castell DO, Schoenfeld PS, Spechler SJ. Nighttime heartburn is an under-appreciated clinical problem that impacts sleep and daytime function: The results of a Gallup survey conducted on behalf of the American Gastroenterological Association. Am J of Gastroenterol 2003;98(7):1487-1493.

Source: AstraZeneca

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