NABI GAINS ORPHAN PRODUCT DESIGNATION FOR CIVACIR IN EUROPE

Nabi Biopharmaceuticals has received orphan medicinal product (OMP) designation from the European Commission for Civacir, the company's product candidate for the prevention of recurrent hepatitis C virus-induced liver disease in liver transplant recipients.

The OMP designation will result in reduced marketing authorization application fees, free access to scientific advice from the EMEA and other potential research and development incentives. Furthermore, if a product with OMP designation is the first to receive marketing authorization in Europe for its designated indication, the product will be entitled to 10 years of marketing exclusivity, which means that a similar drug is prevented from receiving authorization for the same indication during this period. Civacir has already been granted orphan-drug designation from the FDA.