Through this designation, the European Medicines Agency (EMEA) will provide to Talecris ten years of market exclusivity if the product is the first to be approved for marketing in the EU.
In addition, under this designation, EMEA will provide Talecris with clinical development assistance and reduced regulatory fees. Talecris also intends to seek orphan drug designation in the US.
Currently, there are no approved aerosolized treatments available for augmentation therapy for alpha1-antitrypsin deficiency (AAT deficiency).
Larry Stern, CEO of Talecris Biotherapeutics, said: “The European Commission’s designation provides another promising development milestone for Talecris in the expansion of our alpha-1 franchise—a pursuit that reflects our ongoing commitment to offer clinical advancements that will benefit patients.”