Further delays for Eurand's Zentase

Milan, Italy-headquartered specialty pharmaceutical firm Eurand has provided an update on the status of Zentase (EUR-1008), its lead innovative pancreatic enzyme replacement product candidate being developed to treat pancreatic insufficiency.

While Eurand says it has provided responses to the US Food and Drug Administration's questions outlined in its "approvable letter" relating to the manufacture of the product, the firm's raw material supplier will not be filing its answers to queries over the drug master file for several weeks. As a result, Eurand is revising its guidance for the commercial launch of Zentase from the late fourth quarter of 2008 to the first quarter of 2009.

The product is being developed to treat pancreatic insufficiency, a condition associated with cystic fibrosis, chronic pancreatitis and other diseases. The company plans to market Zentase in the USA and out-license it to potential partners elsewhere.