WEST HAVEN, CONNECTICUT -- Thursday, November 21st, 2013 -- NanoViricides, Inc. (NYSE MKT: NNVC) CBS reported yesterday that New York State has seen its first case of dengue fever acquired locally (http://newyork.cbslocal.com/2013/11/20/new-york-states-first-known-dengue-virus-infection-found-on-long-island/). With cases in Florida, Texas and now in New York, in addition to 25,000 suspected cases reported in Puerto Rico this past summer, dengue virus is clearly becoming an important pathogen of concern in the United States.
NanoViricides, Inc. believes that it is a leading company in the fight against dengue. Our DengueCide™ drug candidate has been awarded orphan drug status by the U.S. Food and Drug Administration (FDA) as well as the European Medicines Agency (EMA), covering the USA and all the 27 countries within the European Union. This drug candidate has shown unprecedented effectiveness in a special mouse model that simulates secondary dengue/dengue hemorrhagic fever.
"We believe that DengueCide is going to be a very important drug to treat dengue," said Eugene Seymour, MD, MPH, Chief Executive Officer of the Company, adding, "This recent case of dengue infection locally in New York illustrates that the Aedes Aegypti mosquito carrying dengue virus has reached further north than generally believed. This vector mosquito is already reported to be found in California as well. With this mosquito spreading, there is concern that more cases would be reported in other parts of the USA as well over the next few years."
"DengueCide's effectiveness in mouse model is expected to readily translate to humans," said Anil R. Diwan, PhD, President of the Company, adding, "This is because nanoviricides are designed to directly attack the virus particles in circulation, independently of the host."
The FDA and EMA orphan drug designations cover approximately 750 million people worldwide. These designations will provide a number of significant benefits to NanoViricides as DengueCide eventually moves through the regulatory approval process. These benefits include tax considerations, priority review and a significant extension in patent coverage, among others. The additional patent coverage may be as long as 10 years in the EU. In addition, the Priority Review Voucher (PRV) program of the US FDA specifically includes dengue and dengue hemorrhagic fever.. A PRV can be awarded upon approval of a treatment for dengue. The PRV can then be used by the awardee to accelerate review of another drug in human trials or it can be sold for a consideration.
The Company also recently announced renewal of its testing agreement for DengueCide and next generation dengue therapeutics with the Dr. Eva Harris Laboratory at the University of California, Berkeley.About NanoViricides
FDA refers to US Food and Drug Administration. EMA refers to the European Union’s office of European Medical Agency.