Eurand Announces Findings on Pancreatic Enzyme Product

Eurand has released data from two Phase III clinical trials of its lead product candidate, Zentase, for the treatment of exocrine pancreatic insufficiency (EPI). The FDA has granted fast-track status to Zentase for the treatment of EPI. The company intends to file for FDA approval during the second quarter of 2007 for this potentially first-in-class pancreatic enzyme replacement therapy.

EPI is a deficiency of digestive enzymes normally produced by the pancreas that is commonly associated with cystic fibrosis (CF) and chronic pancreatitis.

Zentase is a zero-overfill, highly stable, porcine-derived pancreatic enzyme replacement therapy. According to the FDA, no currently marketed pancreatic enzyme product has been shown to demonstrate consistent enzyme bioactivity that results in predictable safety and effectiveness.

Zentase met all primary and secondary endpoints in two Phase III clinical trials. The studies were designed to determine whether the product candidate could alleviate serious malabsorption associated with EPI in both pediatric (younger than 7) and older patients.

One randomized, double-blind, placebo-controlled, cross-over study evaluated CF patients with EPI ages 7 and older. Patients treated with Zentase showed a statistically significant increase in the coefficient of fat absorption and the coefficient of nitrogen absorption compared with those receiving a placebo.

An open-label study in CF patients under the age of 7 involved a seven-day dose stabilization period followed by a seven-day treatment period. The study evaluated the percentage of responders, or those patients without excess fat in stools and without signs and symptoms of malabsorption after one and two weeks of treatment. Secondary endpoints included weight change, nutritional status, stool frequency and consistency, incidences of bloating, pain and flatulence as well as physician and parent or guardian judgment of clinical symptoms improvement. In the study, malabsorption symptoms were significantly lower at the end of treatment than at screening, consistent with control of malabsorption symptoms with Zentase in the pivotal Phase III trial.