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news.Nordic Nanovector has received orphan designation from the European Medicines Agency (EMA) and the European Commission (EC) for its lead product candidate Betalutin for the treatment of follicular lymphoma in Europe.
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Orphan status for Betalutin will provide the company several advantages, such as reduced costs related to the clinical development program, as well as commercial exclusivity for ten years once the product reaches the market in Europe.
Nordic Nanovector CEO Jan Alfheim said with the orphan designation for Betalutin in the Europe, the company can receive protocol assistance, a type of scientific advice specific for designated orphan medicines and market exclusivity once the medicine is on the market.
"Fee reductions are also available. These benefits will help tremendously in the development and commercialization of an important new form of treatment of non-Hodgkin Lymphoma," Alfheim said.
Nordic Nanovector is developing new anticancer radioimmuno therapeutics for the treatment of non-Hodgkin Lymphoma (NHL) and other hematological malignancies.
Betalutin is a pharmaceutical product candidate consisting of a radionuclide conjugated to a tumor seeking carrier/antibody, which can be used for irradiation of malignant metastasized tumors with minimal damage to nearby healthy normal tissue.