A grant of orphan drug status provides seven years of market exclusivity for the orphan indication after approval by the FDA, as well as tax incentives, study design assistance, and eligibility for grant funding from the FDA during its development.
Alan Husband, group director of research for Marshall Edwards, said: “This grant of orphan drug status for a third indication, malignant melanoma, is a further indication of the viability of the development program for triphendiol as a multipotent anticancer agent.”