Peregrine Pharmaceuticals announced that the Commission of the European Communities has granted orphan medicinal product designation for Cotara for the treatment of glioma (brain cancer). Cotara has already received Orphan Drug status and Fast Track designation in the United States.
European orphan drug designation makes the product eligible for 10 year market exclusivity. If a product with orphan drug designation receives marketing authorization for its designated indication, the product will be entitled to 10 year market exclusivity, which means that a similar drug is prevented from receiving authorization for the same indication. Orphan drug designation also allows for the possibility of fee waivers and reductions, as well as scientific and regulatory advice from the European Agency.
Peregrine president and CEO Edward J. Legere said, "This is an important new development that significantly expands our potential exclusivity in Europe for the treatment of malignant glioma using Cotara. The company is working closely with the Food & Drug Administration to obtain protocol approval for a Phase III brain cancer clinical trial while it actively seeks a licensing partner for the program. Receiving orphan drug status in Europe can help the Cotara program look even more attractive to potential partners."