Eurand Completes Bioavailability Study of Zentase
On Track to File NDA Before the End of 2007
PHILADELPHIA, Nov. 27, 2007 (PRIME NEWSWIRE) -- Eurand N.V. (Nasdaq:EURX) announced today the completion of a gastrointestinal (GI) bioavailability study on Zentase(tm) (EUR-1008), the Company's lead product candidate for the treatment of exocrine pancreatic insufficiency (EPI). The study was conducted in chronic pancreatitis patients in the U.S.
Results from the study will be included in Eurand's New Drug Application (NDA) for Zentase. Eurand initiated its rolling NDA submission in June 2007 and has been granted fast-track designation by the FDA.
Gearoid Faherty, Chief Executive Officer, commented, "The completion of this study will allow us to complete our NDA submission for Zentase before the end of the year as planned."
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. To date, Zentase has demonstrated positive results in two Phase III trials, one pivotal trial, and a supportive trial in pediatric patients. Eurand believes that the pediatric study was one of the first studies of its type and size conducted in such a young patient population in the United States.
Eurand is a specialty pharmaceutical company that develops enhanced pharmaceutical and biopharmaceutical products based on its proprietary drug formulation technologies. Eurand has had four products approved by the FDA since 2001 and has a pipeline of product candidates in development for itself and its collaboration partners. Eurand has completed two phase III clinical trials on its lead product candidate, Zentase, for the treatment of exocrine pancreatic insufficiency (EPI) and filed a rolling NDA for this product which the company anticipates to complete by the end of 2007. Eurand's technology platforms include bioavailability enhancement of poorly soluble drugs, customized release, taste-making/fast-dissolving formulations and drug conjugation.
Eurand is a global company with facilities in the USA and Europe.
This release, and oral statements made with respect to information contained in this release, constitutes forward-looking statements. Such forward-looking statements include those which express plan, anticipation, intent, contingency, goals, targets or future development and/or otherwise are not statements of historical fact including, but not limited to our plans for our NDA filing, enrollment and future plans for our clinical trials, progress of and reports of results from clinical studies, clinical development plans and product development activities. The words "potentially", "could", "calls for" and similar expressions also identify forward-looking statements. These statements are based upon management's current expectations and are subject to risks and uncertainties, known and unknown, which could cause actual results and developments to differ materially from those expressed or implied in such statements. Factors that could affect actual results include risks associated with the possibility that the FDA refuses to approve our NDA; the outcome of any discussions with the FDA; and unexpected delays in preparation of materials for submission to the FDA as a part of our NDA filing. Forward-looking statements contained in this press release are made as of this date, and we undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Actual events could differ materially from those anticipated in the forward-looking statements.
Posted: November 2007