ASTRAZENECA RECEIVES SIX MONTHS' MARKET EXCLUSIVITY FOR PRILOSEC®

In 1999, the FDA requested that AstraZeneca provide information on the clinical efficacy of Prilosec® in the paediatric population, as well as pharmacologic and clinical safety information. In response to the FDA's request, AstraZeneca submitted the results of a clinical programme consisting of five studies involving children one month to 16 years of age. AstraZeneca is pursuing efforts to have these additional data included in the product labelling to provide guidance on the use of Prilosec® in children.

Prilosec® is not currently indicated for use in children. Prilosec® is indicated for treating certain acid-related conditions, including gastroesophageal reflux disease (GERD), in adults.

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of ethical (prescription) pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of $15.8 billion and leading positions in sales of gastrointestinal, oncology, anaesthesia (including pain management), cardiovascular, central nervous system (CNS) and respiratory products.

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