This designation is based on a recommendation from the Committee for Orphan Medicinal Products.
Dr Paul Laikind, president and CEO, said: “Patients with primary liver cancer often die within months of diagnosis and at this time, they face this disease without any approved drug therapy. This orphan medicinal product designation in the EU builds upon our previous success of obtaining orphan drug designation for MB07133 in the US. Both will help in the development of this product candidate and bring hope of a new treatment option to liver cancer patients in Europe and the US.”
Dr Wayne Frost, vice president, regulatory affairs, said: “The granting of orphan medicinal product designation to MB07133 by the EC is an important piece of the global regulatory strategy for the development of this product candidate in the European Union. This designation provides protocol assistance in which the EMEA will provide advice on the development of MB07133, which should improve the chance of success at the time of marketing authorization to commercialize this much needed therapy.”