NanoViricides could benefit from orphan drug status for tropical disease candidate

As it advances its pipeline of drugs further, NanoViricides(OTCBB:NNVC) says it has filed an orphan drug application with U.S. regulatory authorities for DengueCide, its drug candidate to treat dengue and dengue hemorrhagic fever.

The company, which had hired consulting firm Cote Orphan Consulting to assist with the application, is developing the nanoviricide candidate that has, according to its statement, shown "very high effectiveness" in animals, as well as in cell culture studies of the dengue virus infection - a tropical infectious disease.  

Indeed, NanoViricides said that in a pre-clinical study conducted at the University of California, mice infected with the virus suffered a 100 per cent fatality rate when left untreated, while those mice treated with DengueCide achieved a 50 per cent survival rate. 

The orphan drug designation in the U.S. affords many benefits to drug developers, including tax credits and an extended exclusive marketing period upon drug approval. 

The company said that in addition to this designation, it could be eligible to receive a priority review voucher (PRV) in the U.S, upon approval of a drug against dengue viruses. The PRV can be applied by the company to another drug candidate, it said, or can be sold to another pharmaceutical business. 

According to its release on Monday, no vaccine candidate for the dengue virus infection has succeeded in clinical trials toward approval thus far. 

The mosquito-borne disease, which has re-emerged in the past 20 years, has seen an estimated 400 million cases, causing between 50,000 to 100,000 deaths every year. 

NanoViricides, which has six commercially important drug candidates in its pipeline that together address a market size of greater than $40 billion, is focused first on bringing its FluCide drug candidate to market. 

Should the orphan drug designation for DengueCide be granted, the company's plan is to prioritize this program, allowing it to quickly advance the drug following its development of FluCide. It currently has both an oral and injectable version of FluCide, which has the potential to wipe out virtually all strains of the pesky influenza A virus. 

The company is now preparing for toxicology studies for its first FluCide candidate, expected to be wrapped up before the middle of next year. 

So far this year, NanoViricides' stock has jumped almost 40 per cent, closing Friday at 65 cents.