Published on 24 May 2023 on Zacks via Yahoo Finance

INOVIA's (INO) Rare Disease Drug Gets EC's Orphan Tag, Stock Up

INOVIA Pharmaceuticals INO announced that European Commission has granted orphan drug designation for INO-3107, the company's product candidate for the treatment of Recurrent Respiratory Papillomatosis (“RRP”). INO-3107 is an investigational DNA medicine candidate designed to elicit a targeted T cell response against HPV-6 and HPV-11,the HPV types that cause RRP and other HPV-related disease.

The European Committee for Orphan Medicinal Products had provided positive opinion on INOVIO's application for orphan drug designation in the European Union (EU) for INO-3107.

In the EU, the orphan drug designation is granted for the treatment, prevention and diagnosis of diseases that are life-threatening or chronically debilitating and affect no more than five in 10,000 people. The orphan drug designation will grant INOVIA market exclusivity in the EU for up to 10 years for the above indication, along with financial and regulatory incentives, including protocol assistance at reduced charges and access to centralized marketing authorization.