Eurand Announces Positive Phase III Clinical Study Results
Eurand, a global specialty pharmaceutical company, today unveiled data from two phase III clinical trials on its lead product candidate, Zentase(TM), formerly EUR-1008, for the treatment of Exocrine Pancreatic Insufficiency (EPI). The US Food and Drug Administration (FDA) granted fast track status for 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.
Zentase is a zero-overfill, highly-stable, porcine-derived pancreatic enzyme replacement therapy used to treat EPI and was designed to meet FDA guidelines for pancreatic enzyme replacement products(1). According to the FDA, no currently marketed pancreatic enzyme product (PEP) has been shown to demonstrate consistent enzyme bioactivity that results in predictable safety and effectiveness(2). Many of the current enzyme products contain overfill to compensate for product instability during shelf life, which can lead to variability in dosing. As a highly-stable product, Zentase does not require overfill. Currently, there are no FDA approved PEPs for the treatment of EPI on the market in the US.
"We are excited to present the results of our phase III studies supporting Zentase for the full spectrum of cystic fibrosis patients suffering from EPI, including those needing limited supplementation to those with very aggressive enzyme deficiency," said Gearoid Faherty, Eurand Chairman and CEO.
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 a pediatric (younger than 7 years) and an older patient population.
Study results showed a clinically and statistically significant increase in the coefficient of fat absorption (CFA) in patients treated with Zentase. The mean percentage of CFA in patients receiving Zentase was 88.3 percent versus 62.8 percent in patients receiving placebo (p