Eurand's EUR-1008 eligible for EU centralized review

Italy's Eurand NV, a specialty drug company that develops, manufactures and commercializes enhanced pharmaceutical and biopharmaceutical products based on its proprietary drug formulation technologies, says that the European Medicines Agency (EMEA) has confirmed that a marketing application for EUR-1008 (Zentase) is eligible for Community (Centralized) Marketing Authorization submission in the European Union.

Eurand plans to file a marketing application for EUR-1008,its pancreatic enzyme product candidate, through a centralized procedure, the approval of which would allow market access to all 27 EUn member states. In 2007, the market value for pancreatin products in these countries was approximately $345.0 million), according to IMS Health.

Gearoid Faherty, chief executive 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."