NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that it has filed an Orphan Drug application with the Office of Orphan Product Development (OOPD) of the US FDA for DengueCide™, its drug candidate for the treatment of dengue and dengue hemorrhagic fever.
The Company previously engaged the consulting firm Cote´ Orphan Consulting (COC), headed by Dr. Tim Cote´, to assist with the orphan drug application. The Company, in consultation with COC, has determined that its current lead DengueCide™ drug candidate is eligible for orphan drug status application in the USA.
DengueCide is a nanoviricide® that has shown very high effectiveness in animal models of dengue virus infection and also in cell culture studies of dengue virus infection. These animal studies as well as cell culture studies were conducted in the laboratory of Dr. Eva Harris, Professor of Public Health and Infectious Diseases at the University of California, Berkeley. Prof. Harris found that the special laboratory mouse strain AG129 infected with a dengue virus in a lethal challenge ADE-simulation protocol, when left untreated, suffered a 100% fatality rate. In contrast, in the same study, animals treated with NanoViricides' DengueCide achieved an unprecedented 50% survival rate.
Dengue and dengue hemorrhagic fever have been designated as orphan drug status eligible diseases in the USA. Orphan Drug designation enables several benefits to promote drug development that include tax credits and an extended exclusive marketing period upon drug approval. These benefits provide significant financial incentives for developing orphan drugs. However, there can be no assurance that DengueCide will be granted an orphan drug designation.
In addition to the incentives related to orphan drug status, the Company may be eligible to receive a Priority Review Voucher (PRV) in the USA, upon approval of a drug against dengue viruses. A PRV can be applied by the Company to another drug candidate to obtain a "priority review" to speed up the regulatory process for that other drug. A PRV can also potentially be sold to another pharmaceutical company to obtain an immediate financial benefit. The value of a PRV has been variously estimated to be between $200M to $600M for such transactions.
There is currently neither an effective drug treatment nor a vaccine for dengue virus infection. Tremendous efforts have been made for dengue vaccine development but, to date, no vaccine candidate has succeeded in clinical trials towards approval.