MONDAY, JUNE 18, 2018

NanoViricides submits letter of intent to file drug application with EMA

NanoViricides, Inc., a development-stage biopharmaceutical company, announced on Monday that it submitted its letter of intent to file an orphan drug application for DengueCide with the European Medicines Agency.

DengueCide is the company's drug candidate for the treatment of dengue and dengue hemorrhagic fever. DengueCide is a nanoviricide that demonstrated very high effectiveness in an animal model of infection with the dengue virus. The drug candidate showed a 50 percent survival rate in mice treated with DengueCide. Untreated mice experienced a 100 percent fatality rate.

There are currently no effective drug treatments or vaccines for dengue virus infection.

The EMA requires a notification of intent to file at least 60 days before actual filing. The application will need to be translated into 27 different languages before it is submitted.

NanoViricides engaged the consulting firm Coté Orphan Consulting to help with the orphan drug application. After consulting with COC, the company determined DengueCide was eligible for orphan drug status application in the European Union. NanoViricides also recently filed an orphan drug designation application for DengueCide to the U.S. Food and Drug Administration.

If an orphan designation is granted for DengueCide, NanoViricides will be more able to assign a higher priority to its dengue drug program and rapidly develop the drug candidate.

Dengue fever causes an estimated 50,000 to 100,000 deaths globally each year.