Immunology

NanoViricides, Inc. (NYSE MKT:NNVC) (the "Company") announced today that the European Medicines Agency (EMA), has awarded orphan drug designation to DengueCideâ„¢, the Company's drug candidate for the treatment of dengue and dengue hemorrhagic fever. Dengue Fever is a mosquito-borne disease that, according to the WHO, affects approximately 400 million people per year. Dengue Hemorrhagic Fever, a subset of the disease that can occur after reinfection with another strain of the same virus, has a case fatality rate of up to 20%.

This orphan drug designation enables several benefits for the Company's dengue drug development program. These benefits include "protocol assistance," or specific scientific advice that can speed up the drug development program, as well as certain fee reductions, for drug approval(s) under EMA.

More importantly, an approved orphan medicine in the EMA countries is expected to benefit from ten years of marketing exclusivity protection. An additional two years of exclusivity can be obtained if the drug development has complied with an agreed pediatric investigation plan, with a total of twelve years of market exclusivity for a drug that is approved for both adult and pediatric usage. Further information on the incentives offered can be found at the EMA website http://www.ema.europa.eu.

Applications for orphan designation are examined by the European Medicines Agency's Committee for Orphan Medicinal Products (COMP), using a network of international experts. This designation is recognized by all 27 countries within the European Union.

The Company has previously reported that DengueCide was awarded orphan drug status by the US FDA. The Company has also recently reported the renewal of its evaluation agreement for DengueCide and next generation dengue therapeutics with the Dr. Eva Harris Laboratory at the University of California, Berkeley.

In the USA, orphan drug designation qualifies NanoViricides for certain tax credits and marketing incentives under the Orphan Drug Act. In addition, the Company will qualify for the waiver of certain FDA fees if and when it files the New Drug Application (NDA) for DengueCide with the FDA. Further, the Company will also be eligible for a "Priority Review Voucher" (PRV) from the US FDA when the Company files a NDA for DengueCide.

"Our dengue drug development programs have been accelerated in order to take advantage of these benefits," said Eugene Seymour, MD, MPH, CEO of the Company. DengueCide is in pre-clinical development at present. If the pre-clinical development is successful, the Company will need to file an "Investigational New Drug" (IND) application to the US FDA and perform human clinical trials. If the human clinical trials are successful, then the Company has to file a NDA to the FDA to obtain approval to market the drug. There is no guarantee that DengueCide will successfully result in an NDA or a marketable drug product.

If the Company receives a Priority Review Voucher, it can be applied to accelerate the review of another one of our own drugs or it can be sold to another pharmaceutical company for a consideration. Priority review means that the FDA aims to render a decision on the NDA in 6 months. In contrast, the FDA aims to complete a standard review in about 10 months, and it often takes even longer. The estimated economic value of a PRV depends upon the drug class, and could be as high as a few hundred million dollars, according to Duke economists (Ridley et al. 2006; Grabowski et al. 2009). (https://faculty.fuqua.duke.edu/~dbr1/voucher/).