On October 20, 2017 VBL Therapeutics (Nasdaq:VBLT), a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer, reported that the European Medicines Agency (EMA) has designated ofranergene obadenovec (VB-111) as an “orphan medicinal product” for the treatment of ovarian cancer, adding to the orphan status already granted for glioblastoma in US and Europe (Press release, VBL Therapeutics, OCT 20, 2017, View Source [SID1234521052]). VB-111 is the Company’s lead product candidate currently being studied in a Phase 3 pivotal trial for recurrent glioblastoma, with launch of a Phase 3 in platinum-resistant ovarian cancer expected by the end of the year.

“The receipt of an Orphan Drug Designation is a key regulatory milestone that is designed to provide a number of important benefits, including the potential for conditional marketing authorization and ten years of market exclusivity for VB-111,” said Prof. Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics.

Orphan Drug Designation is granted by the EMA to drugs that are intended for the treatment of life-threatening or chronically debilitating rare diseases, where no satisfactory treatment of the condition concerned is authorized. If such a treatment exists, then the medicine must be of significant benefit to those affected by the condition. Rare diseases are those defined as having a prevalence of not more than five per 10,000 persons in Europe. The Orphan Drug Designation provides potential incentives for the sponsor from the European Union to develop a medicine for a rare disease, such as protocol assistance, reduced fees, funding from the EC for clinical trials and protection from competition once the medicine is placed on the market, including ten years of market exclusivity.