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Eurand's Zentase Effective in Treating Exocrine Pancreatic,Insufficiency, Studies Show

Zentase Improves Absorption of Fat, Protein and Other Nutrients in Patients with Mild, Moderate or Severe Malabsorption, While Controlling Symptoms of Exocrine Pancreatic Insufficiency

MILAN, Italy and DAYTON, Ohio, June 19, 2007 /PRNewswire-FirstCall/ -- Eurand N.V. today announced results that were presented at the recent European Cystic Fibrosis Society meeting in Antalya, Turkey, held June 13-16. Results from two phase III studies of Zentase(TM) (EUR-1008) showing a statistically and clinically significant improvement in the absorption of fat, protein and nutrients in patients suffering from Exocrine Pancreatic Insufficiency (EPI). Absorption levels were measured by coefficient of fat (CFA) and coefficient of nitrogen (CNA) absorption, common measurements for malabsorption in EPI patients. In the pivotal study, the mean CFA after Zentase was 88.3 percent and the mean CNA after Zentase was 87.2 percent. Levels under placebo were 62.8 and 65.7 percent respectively (p=0.001). Scientific evidence suggests that to normalize EPI, treatment needs to raise CFA levels to at least 85 percent.(1)

The data were the basis for the recent rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Zentase as a treatment for EPI. EPI is a potentially lethal disease marked by the deficiency of digestive enzymes normally produced by the pancreas. This deficiency results in poor digestion and reduced absorption of nutrients, which, if left untreated, can lead to malnutrition, impaired growth, weakened immune response, and shortened life expectancy. Treatment with pancreatic enzyme products (PEPs) replaces enzymes lost through the disease. Currently, there are no known alternative therapies to PEPs for EPI.

EPI can occur as a complication of a variety of diseases, including cystic fibrosis, pancreatic cancer, surgery and chronic pancreatitis. There are no reliable statist
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