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Eurand Announces EUR-1008 (Zentase) Eligibility for European Centralized Review

Corporate news announcement processed and transmitted by Hugin ASA.
The issuer is solely responsible for the content of this
announcement.
----------------------------------------------------------------------
--------------




MILAN, Italy, April 22, 2008 (PRIME NEWSWIRE) -- Eurand N.V.
(Nasdaq:EURX), a specialty pharmaceutical company that develops,
manufactures and commercializes enhanced pharmaceutical and
biopharmaceutical products based on its proprietary drug formulation
technologies, announced today that the European Medicines Evaluation
Agency (EMEA) confirmed that a marketing application for EUR-1008
(Zentase) is eligible for Community (Centralized) Marketing
Authorization submission in the European Union (EU). Eligibility was
granted under Article 3(2)b of regulation EC No. 726/2004, which
relates to products that offer a significant technological
innovation.
 
Eurand plans to file a marketing authorization application (MAA) for
EUR-1008, the Company's pancreatic enzyme product candidate, through
a centralized procedure, the approval of which would allow market
access to 27 European Union member states. In 2007, the market value
for pancreatin products in these countries was approximately $345
million (Euro 230 million), according to IMS.
 
Gearoid Faherty, Chief Executive Officer of Eurand, commented, "We
are particularly pleased to be eligible for Centralized Review on the
basis of technical innovation. We believe our product has the
potential to resolve many of the problems commonly associated with
existing products."
 
Mr. Faherty continued, "Filing through the centralized procedure
offers significant advantages, including the possibility to gain
market access to 27 countries in one efficient process and, upon
approval, eligibility for a minimum of 10 years of market
exclusivity. It remains our intention to out-license marketing rights
for EUR-1008 in Europe and we are in advanced negotiations with a
number of potential partners. The timing of completing an
out-licensing negotiation will be influenced by our intent to file
the MAA in our own name. We will meet with the EMEA soon to define
the requirements for our MAA."
 
About EUR-1008 (Zentase)
 
Eurand's lead product candidate, EUR-1008 (Zentase), is an innovative
pancreatic enzyme replacement therapy which is being developed to
treat pancreatic insufficiency, a condition associated with cystic
fibrosis, chronic pancreatitis and other diseases.
 
The product was developed in response to the 2004 Food and Drug
Administration (FDA) guidance on pancreatic enzyme products, which
outlined the need to reduce the unpredictable nature of currently
marketed enzyme therapies. The product is a highly stable formulation
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. Eurand
completed its New Drug Application (NDA) submission for EUR-1008 in
December 2007, which has been granted priority review status. The
Company plans to market the product in the U.S. and out-license the
product outside of 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 partnered 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, EUR-1008 (Zentase), intended for the treatment of
pancreatic insufficiency and has submitted an 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. For
more information, visit Eurand's website at www.eurand.com.
 
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.

CONTACT: Eurand N.V.
Mario Crovetto, Chief Financial Officer
+39 02 95428 521
mario.crovetto@eurand.com

The Ruth Group
Nick Laudico
646-536-7030
nlaudico@theruthgroup.com
Elizabeth Scott
646-536-7014
escott@theruthgroup.com



--- End of Message ---

Eurand N.V.
845 Center Drive Vandalia, Ohio USA

WKN: A0MSPK; ISIN:
NL0000886448;
;



 
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