Adherex Technologies, a developer of oncology products, has received orphan drug status for Eniluracil.
Eniluracil, which was licensed from GlaxoSmithKline, is intended to treat hepatocellular (liver) cancer.
The FDA uses orphan drug status to encourage development of drugs that treat diseases that afflict fewer than 200,000 people. If the drug receives FDA approval, Adherex would receive as much as seven years of market exclusivity. Other benefits include the potential of funding for clinical studies, tax credits, study design assistance and waiver of some FDA fees.
According to Adherex, some 17,500 cases of hepatocellular cancer are diagnosed each year.