PHILADELPHIA, PA -- (Marketwire) -- 06/22/09 -- Eurand N.V. (NASDAQ: EURX), a specialty
pharmaceutical company that develops enhanced pharmaceutical and
biopharmaceutical products based on its proprietary pharmaceutical
technologies, announced that the U.S. Food and Drug Administration (FDA)
has advised the Company that it has extended the June 2009 user fee goal
date for the New Drug Application for ZENPEP(TM) (pancrelipase capsules) by
three months.
The FDA did not request that the Company provide any further information,
but attributed the reason for the delay to the need for additional time to
review the current submission.
About ZENPEP (pancrelipase capsules)
ZENPEP is a proprietary pancreatic enzyme product 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 2004 FDA initial 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. ZENPEP is a highly stable formulation of a porcine
pancreatic extract that is biologically similar to the endogenous human
pancreatic secretions necessary for proper human digestion.
About Eurand
Eurand is a specialty pharmaceutical company that develops, manufactures
and commercializes enhanced pharmaceutical and biopharmaceutical products
based on its proprietary pharmaceutical technologies. Eurand has had five
products approved by the FDA since 2001 and has a pipeline of product
candidates in development for itself and its collaboration partners. The
Company'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 www.eurand.com.
Eurand 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 ZENPEP, 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 ZENPEP 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.
Investor Contacts:
Bill Newbould
Vice President, Investor Relations
Eurand N.V.
+1 267-759-9335
Email Contact
Nick Laudico/Sara Pellegrino
The Ruth Group
+1 646-536-7030/7002
Email Contact
Email Contact