30 Jan 2009 - Eurand N.V. (NASDAQ: EURX), a specialty pharmaceutical company that develops enhanced pharmaceutical and biopharmaceutical products based on its proprietary drug formulation technologies, is pleased to announce that the U.S. Food and Drug Administration (FDA) has acknowledged the Company's response to the June 2008 approvable letter for EUR-1008 (ZENTASE(R)) as a complete response. The FDA has assigned an action date under the Prescription Drug User Fee Act (PDUFA) of late second quarter 2009.

As previously disclosed, Eurand's raw material supplier submitted its response to the FDA's questions regarding the Drug Master File (DMF) for EUR-1008 on December 23, 2008, following Eurand's August 2008 response to the approvable letter.

About EUR-1008 (ZENTASE(R))

Eurand's lead product candidate, EUR-1008 (ZENTASE(R)), is an innovatively formulated pancreatic enzyme product that is being developed for the treatment of exocrine pancreatic insufficiency, a condition associated with cystic fibrosis, chronic pancreatitis and other diseases. The product was developed in response to the 2006 FDA guidance on pancreatic enzyme products, which outlined the need to reduce the variability in enzyme levels and stability of currently marketed enzyme therapies and regulate them under NDAs. EUR-1008 is a highly stable formulation of a porcine pancreatic extract that includes eight key enzymes and a number of coenzymes and cofactors and is biologically similar to the endogenous human pancreatic secretions necessary for proper human digestion. The Company plans to market EUR-1008 in the U.S. and out-license the product outside the U.S.

About Eurand

Eurand is a specialty pharmaceutical company that develops, manufactures and commercializes 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. Its technology platforms include bioavailability enhancement of poorly soluble drugs, custom release profiles, taste-masking orally disintegrating tablet (ODT) formulations, and drug conjugation.

Eurand is a global company with facilities in the U.S. and Europe. For more information, visit Eurand's website at http://www.eurand.com.