NanoViricides, Inc. (NYSE MKT:NNVC) (the "Company") announced today that the European Medicines Agency (EMA), has awarded orphan drug designation to DengueCide™, 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/).
The Company engaged the consulting firm Coté Orphan Consulting (COC), headed by Dr. Tim Coté, to assist with our DengueCide orphan drug applications to both the US FDA and the EMA.
DengueCide is a nanoviricide® that has shown very high effectiveness in an animal model of dengue virus infection. These animal studies were conducted in the laboratory of Dr. Eva Harris, Professor of Public Health and Infectious Diseases at the University of California, Berkeley. Professor Harris has developed a mouse model of antibody-dependent-enhancement (ADE) of dengue infection that simulates dengue hemorrhagic fever (DHF/DHSS) using a special laboratory mouse strain called AG129. In humans DHF/DHSS is associated with a high fatality rate. In this model, infection with a dengue virus, when the mice are left untreated, is 100% fatal. In contrast, in the same study, animals treated with NanoViricides' DengueCide achieved an unprecedented 50% survival rate.
There is currently neither an effective drug treatment nor a vaccine for dengue virus infection. No vaccine or drug candidate has succeeded in clinical trials towards approval as of this date in spite of significant development efforts. Several dengue virus vaccine clinical trials are ongoing. Previously, a drug called poly-IC-lC received an orphan designation in 2003 for dengue treatment in the USA. This drug is supposed to act as an immune booster and is in several clinical trials. Three additional treatments for dengue fever are found in a search of the clinical trials database (http://clinicaltrials.gov/ct2/results?term=dengue&pg=5&show_xprt=Y). These include chloroquine, balapiravir (Roche), and celgosivir.
The Company continues to advance its injectable and oral FluCide™ broad-spectrum anti-influenza drug candidates towards clinical trials. Both of these drug candidates have shown extremely high effectiveness and substantial superiority to Tamiflu®, the standard of care, in the unrelated influenza virus types H1N1 and H3N2 in a high lethality animal model.
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