ZenpepTreatment for Pancreatic Exocrine Dysfunction
Update: Zenpep Now FDA Approved - August 27, 2009
Eurand Completes New Drug Application for Zentase
PHILADELPHIA, Dec. 20, 2007 (PRIME NEWSWIRE) -- Eurand N.V., 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 (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.
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 and has submitted its NDA for this product. Eurand's technology platforms include bioavailability enhancement of poorly soluble drugs, customized release, taste-masking/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: December 2007
- Eurand Granted FDA Approval for Zenpep - August 28, 2009
- Eurand Receives Approvable Letter From FDA for EUR-1008 (Zentase) - June 19, 2008
- Eurand Granted Priority Review for Zentase NDA - February 21, 2008
- Eurand Files NDA for Zentase for Exocrine Pancreatic Insufficiency - June 12, 2007