Genta Incorporated (OTCBB: GETA.OB) today announced that tesetaxel, the leading oral taxane in clinical development, has been designated as an Orphan Drug by the European Medicines Agency for gastric cancer. The drug has previously received Orphan Drug designation by the U.S. Food and Drug Administration for both gastric cancer and melanoma, as well as Fast Track designation by FDA for gastric cancer.
Orphan designation for a medicinal product by the EMA provides for scientific advice during the product-development phase, direct access to centralized marketing authorization, and certain financial incentives. The designation also provides 10 years of marketing exclusivity subsequent to approval. Orphan drugs are eligible for full (100%) reduction of fees associated with pre-authorization inspections, as well as full reduction of marketing application fees and annual fees for qualifying companies. Earlier this year, Genta’s qualifying status for this purpose as a “small and medium-sized enterprise” was renewed by the EMA.