Eurand Files Zentase NDA

Eurand Pharmaceuticals Ltd. initiated the rolling submission of its NDA with the FDA for Zentase for the treatment of Exocrine Pancreatic Insufficiency (EPI), a deficiency of digestive enzymes normally produced by the pancreas that can result from a number of diseases, including cystic fibrosis, chronic pancreatitis, and pancreatic cancer. Zentase, the company’s lead product candidate, has been granted fast-track designation by the FDA.

Zentase is a pancreatic enzyme product (PEP) designed to meet FDA guidelines for PEPs. In April 2004, the FDA mandated that all manufacturers of EPI drug products file a NDA and receive approval for their products by April 2008 or be subject to regulatory action.

Pancreatic enzyme products are inherently unstable and in order to compensate for enzyme degradation over time, all manufacturers currently include an overfill of enzymes in the finished product. As a result, patients receive PEPs with variable and uncertain levels of potency, resulting in inconsistent therapeutic effect. In April 2006, the FDA issued ‘Guidance for Industry’ addressing the elimination of product overfill allowed under current regulations. As a highly stable product, Zentase does not require overfill and is filled at 100% of label claim.

The Zentase NDA filing includes the results of two Phase III studies that show a clinically relevant increase in the absorption of fat, protein and other nutrients, which is maintained over time. The studies also show that Zentase led to fewer symptoms associated with impaired nutrient absorption and was well tolerated.