Eurand to Present Zentase Phase III Data
-- Exocrine pancreatic insufficiency (EPI) is a deficiency of digestive
enzymes normally produced by the pancreas that can result from a number
of diseases, including cystic fibrosis, chronic pancreatitis, and
pancreatic cancer
-- EPI results in poor digestion and reduced absorption of nutrients
which, if untreated, can lead to impaired growth in children, impaired
immune response and shortened life expectancy
-- Treatment with pancreatic replacement products replaces enzymes lost
through this disease. Other than enzyme replacement, no known
alternative therapy for the loss of digestive enzymes is currently
available
-- Eurand completed two phase III clinical trials on its lead product
candidate, Zentase(TM), for the treatment of EPI
-- Eurand expects to initiate a rolling submission of its new drug
application (NDA) with the US Food and Drug Administration (FDA) for
Zentase for the treatment of EPI in the 2nd quarter of this year
-- Posters 243-246 will be presented on June 15th between 1:30-2:30pm:
1. Zentase, a New Pancreatic Enzyme Product (PEP), Is Safe and
Effective in Cystic Fibrosis (CF) Patients with Exocrine Pancreatic
Insufficiency (EPI)
2. Zentase, a New Pancreatic Enzyme Product (PEP), in Young Cystic
Fibrosis (CF) Patients with Exocrine Pancreatic Insufficiency (EPI)
3. Child friendly dosing options for PEPs
4. Overfilling in Current Pancreatic Enzyme Products (PEPs): Still an
Unresolved Issue
For more information on Zentase and Eurand
Contact: Marian Cutler, Eurand, +1-973-517-0519
This media alert, 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 Eurand's 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 "expect" 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 apart 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: Marian Cutler of Eurand, +1-973-517-0519
Web site: http://www.eurand.com/
Ticker Symbol: (:EURX)
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Posted: June 2007
