Eurand's Raw Material Supplier Submits Response to FDA for DMF-Related Questions On EUR-1008 (ZENTASE(r))


PHILADELPHIA, Dec. 23, 2008 (GLOBE NEWSWIRE) -- Eurand N.V. (Nasdaq:EURX), a
specialty pharmaceutical company that develops enhanced pharmaceutical and
biopharmaceutical products based on its proprietary drug formulation
technologies, today announced that its raw material supplier has filed its
response to questions relating to the Drug Master File (DMF) raised by the U.S.
Food and Drug Administration (FDA) for EUR-1008 (ZENTASE(r)), an innovative
pancreatic enzyme replacement product (PEP). This filing is in addition to the
response that Eurand submitted in August 2008 to the FDA's questions relating
to the manufacture of EUR-1008 in its June 2008 approvable letter. 

"We are pleased that our raw material supplier has completed its response to
the FDA's questions on the DMF," said Gearoid Faherty, Chairman and Chief
Executive Officer. He noted that the FDA recently held an advisory committee
meeting for another PEP and that Eurand's raw material supplier had taken note
of the panel's recommendations in preparing its reply to the FDA's questions
but that Eurand was unsure what, if any, impact the committee's proposed
recommendations for that product might have on review or timing of the review
of the NDA for EUR-1008. 

Separately, the Company announced that late-stage negotiations are continuing
for a European partner for EUR-1008, and it expects to finalize a distribution
agreement in early 2009. 

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 www.eurand.com. 

Forward-Looking Statement

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 the future and status of our NDA
filing for EUR-1008, 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",
"anticipates", "could", "calls for", "expects", 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 does not approve our NDA relating to EUR-1008 or continues to delay
approval; the outcome of any discussions with the FDA; and unexpected delays or
additional requirements in preparation of materials for submission to the FDA
as a part of our NDA filing, including those relating to Eurand's raw material
supplier. 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. 

CONTACT: Eurand N.V.
         Bill Newbould, Vice President, Investor Relations
         +1 267-759-9335
         bill.newbould@eurand.com
         
         The Ruth Group
         Nick Laudico
           +1 646-536-7030
         nlaudico@theruthgroup.com
         Sara Ephraim
           +1 646-536-7002
           sephraim@theruthgroup.com