FDA Issues Complete Response Letter to GlaxoSmithKline for Eurand's EUR-1048

GlaxoSmithKline Responds to Complete Response Letter

PHILADELPHIA, Dec. 26, 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 it has been advised by GlaxoSmithKline
(NYSE:GSK) that the U.S. Food and Drug Administration (FDA) has issued a
Complete Response letter for the New Drug Application (NDA) for EUR-1048.
EUR-1048 is an orally disintegrating tablet (ODT) formulation with an
undisclosed active compound co-developed by Eurand and GSK. 

GSK also has informed Eurand that it submitted its response to the Complete
Response letter on December 24th and anticipates that the FDA will take up to
60 days to review the response and take action on the NDA. 

Separately, the FDA also has advised GSK that the review of another
collaborative product, EUR-1000, has been extended into 2009. EUR-1000 is an
AB-rated generic equivalent to Inderal LA. 

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 partnered
products approved by the FDA since 2001 and has a pipeline of product
candidates in development for itself and its collaboration partners. Eurand's
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" 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
          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