PHILADELPHIA, Dec. 20, 2007 (PRIME NEWSWIRE) -- Eurand N.V. (Nasdaq:EURX), a specialty pharmaceutical company that develops enhanced pharmaceutical and biopharmaceutical products based on its proprietary drug formulation technologies, announced today that it has completed the filing of its New Drug Application (NDA) with the Food and Drug Administration (FDA) for Zentase(tm) (EUR-1008), the Company's lead product candidate for the treatment of exocrine pancreatic insufficiency (EPI).
Eurand initiated its rolling NDA submission in June 2007 and was granted fast-track designation by the FDA.
In the NDA, the Company included results from two Phase III trials, one pivotal trial, and a supportive trial of Zentase in pediatric patients. Also included in the NDA were results from a gastrointestinal (GI) bioavailability study of Zentase conducted in chronic pancreatitis patients in the U.S., which was completed in November 2007.
Gearoid Faherty, Chief Executive Officer of Eurand, commented, "The completion of our NDA filing for Zentase marks an important milestone for Eurand. With the file now under review, our current focus is on the build out of our Sales and Marketing infrastructure for the anticipated launch of Zentase and integrating the recently announced SourceCF acquisition."
Zentase is a porcine-derived pancreatic enzyme replacement therapy which is being developed to treat EPI, a condition associated with cystic fibrosis (CF), chronic pancreatitis and other conditions. The product is a highly stable formulation that includes eight key enzymes and a number of coenzymes and cofactors and is biologically similar to endogenous human pancreatic secretions necessary for proper human digestion
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