MILAN, Italy and DAYTON, Ohio, Feb. 26, 2008 (PRIME NEWSWIRE) -- Eurand N.V. (Nasdaq:EURX), a specialty pharmaceutical company that develops enhanced pharmaceutical and biopharmaceutical products based on its proprietary drug formulation technologies, announced positive results of a pilot pharmacokinetic study of EUR-1025, the Company's proprietary once-a-day (QD) oral formulation of ondansetron hydrochloride. Ondansetron hydrochloride is marketed under the brand name Zofran(r) by GlaxoSmithKline for the treatment and prevention of chemotherapy-induced nausea and vomiting.
The study was designed to compare the pharmacokinetic profile of a QD oral formulation of EUR-1025 to an 8 mg tablet of Zofran(r) dosed twice per day. The study achieved its goal of producing a formulation with a similar pharmacokinetic profile which was bioequivalent when normalized for dose.
The study was conducted using healthy volunteers. Plasma ondansetron levels were measured and analyzed for standard pharmacokinetic parameters. The extended release properties of the proprietary technology used resulted in a QD formulation with comparable delivery of drug to reference. There were no serious adverse events and all of the subjects completed the study.
Gearoid Faherty, Chief Executive Officer of Eurand, commented, "We are extremely encouraged by the positive results from this study. Current formulations of ondansetron are administered from two, to four times per day. Our once-a-day formulation, developed using our proprietary Diffucaps(r) technology, has the potential to offer patients significant advantages. We look forward to discussing the further development of this product with the Food and Drug Administration (FDA) and anticipate commencing pivotal studies if required later this year."
About EUR-1025
EUR-1025 is a once-a-day oral formulation of ondansetron, an anti-emetic, currently sold under the brand name Zofran(r) by GlaxoSmithKline. For the 12 months ended September 30, 2007, ondansetron had reported worldwide sales of approximately $1.6 billion, approximately $1 billion of which were for the oral dosage form. Ondansetron has very challenging physicochemical properties and this product is being developed using an advanced application of Eurand's Diffucaps(r) technology.
About Eurand
Eurand is a specialty pharmaceutical company that develops enhanced pharmaceutical and biopharmaceutical products based on its proprietary drug formulation technologies. Eurand has had four 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, Zentase, intended for the treatment of Exocrine 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.