Orphan Drug Designation

Among Active Biotech’s projects, laquinimod, paquinimod and tasquinimod have received orphan drug designation for treatment of Huntington’s disease, systemic sclerosis and multiple myeloma, respectively.

The orphan drug designation is implemented to promote the development of drugs that may provide significant benefit to patients suffering from rare conditions. To qualify for orphan designation, a medicine must meet a number of criteria, e.g. it must be intended for a life-threatening or chronically debilitating disease. Also, the condition has to be rare and the medicine must provide significant benefit to those affected by the disease. Orphan drug designation provides for seven to ten years of market exclusivity against competition, as well as certain incentives. For further information regarding orphan drug designation, please see the websites for EMA or FDA.