 |
|
 |
 |
|
Eurand Provides Update On EUR-1008 (ZENTASE) |
|
Corporate news announcement processed and transmitted by Hugin ASA.
The issuer is solely responsible for the content of this
announcement.
----------------------------------------------------------------------
--------------
PHILADELPHIA, Sept. 30, 2008 (GLOBE 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, today provided an update on the status of its
late-stage development product EUR-1008 (ZENTASE(r)), an innovative
pancreatic enzyme replacement product (PEP).
In June 2008, the U.S. Food and Drug Administration (FDA) issued an
approvable letter to Eurand for EUR-1008. While Eurand has provided
its responses to the FDA's questions relating to the manufacture of
the product, the Company has been advised by its raw material
supplier that, further to a recent discussion with the FDA, it now
anticipates filing its response to questions relating to the DMF
(Drug Master File) in the coming weeks.
Given the projected timing of its raw material supplier's response to
the FDA's questions and accounting for FDA review time, Eurand is
revising its guidance for anticipated approval and commercial launch
of EUR-1008 from the late fourth quarter of 2008 to the first quarter
of 2009. The anticipated timeline is entirely dependent on the timing
and substance of the remaining FDA review.
Eurand Chief Executive Officer Gearoid Faherty said, "We look forward
to working with the FDA to complete the NDA review process as soon as
possible and bring this important new product to market early next
year."
About EUR-1008 (ZENTASE(r))
Eurand's lead product candidate, EUR-1008 (ZENTASE(r)), 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. EUR-1008 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. The
Company plans to market EUR-1008 in the U.S. and out-license it
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'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 U.S. and Europe.
For more information, visit Eurand's website at 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 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, Inc.
Bill Newbould
267-759-9335
bill.newbould@eurand.com
The Ruth Group
Nick Laudico
646-536-7030
nlaudico@theruthgroup.com
Sara Ephraim
646-536-7002
sephraim@theruthgroup.com
--- End of Message ---
Eurand N.V.
845 Center Drive Vandalia, Ohio USA
WKN: A0MSPK; ISIN:
NL0000886448;
; Copyright © Hugin AS 2008. All rights reserved.
|
|
|
|
| |
 |
durchschnittliche Punktzahl: 0 Stimmen: 0
| |
 |
|
|
 |  |