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news.Morphotek, a subsidiary of Eisai Corporation of North America, has announced that the European Commission has granted orphan drug status to the monoclonal antibodies, farletuzumab or MORAb-003, for the treatment of ovarian cancer and MORAb-009 for the treatment of pancreatic cancer.
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Created to encourage R&D of drugs for diseases with small patient populations, orphan drug designation in the European Union (EU) provides for 10 years of market exclusivity in the EU following marketing authorization, fee reductions for certain regulatory activities related to the development of the antibodies, direct access to the centralized procedure of the European Medicines Agency (EMEA) for review of marketing applications and possible R&D grants from certain EU member states.
Nicholas Nicolaides, president and CEO of Morphotek, said: “We are very pleased to have received the European Commission’s orphan drug designation for these investigational treatments. This further strengthens these two important programs by offering several clinical development and commercialization benefits.”