Eurand's Zentase is bioavailable in study

Dutch drug developer Eurand NV has completed a gastrointestinal bioavailability study on Zentase (EUR-1008), the company's lead product candidate for the treatment of exocrine pancreatic insufficiency. Results from the trial will be included in Eurand's US New Drug Application for Zentase. The firm initiated its rolling submission in June 2007 and has been granted fast-track designation by the Food and Drug Administration.

Zentase is a porcine-derived pancreatic enzyme replacement therapy which is being developed to treat EPI, a condition associated with cystic fibrosis, chronic pancreatitis and other conditions. The product is a highly stable formulation that includes eight key enzymes and a number of co-enzymes and co-factors and is biologically similar to endogenous human pancreatic secretions necessary for proper human digestion. To date, Eurand says Zentase has demonstrated positive results in two Phase III trials, one pivotal study, and a supportive program in pediatric patients. The company believes that the pediatric study was one of the first studies of its type and size conducted in such a young patient population in the USA.