Eurand N.V, a specialty pharmaceutical company that develops, manufactures and commercialises enhanced pharmaceutical and biopharmaceutical products, said that the European Medicines Evaluation Agency (EMEA) confirmed that a marketing application for EUR-1008 (Zentase) is eligible for community (centralized) marketing authorisation 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 authorisation 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.
Gearóid Faherty, chief executive officer, 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. 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."
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 US and out-license the product outside of the US.