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.