NanoViricides Reports that the DengueCide™ Orphan Drug Application Has Been Submitted and Received by the European Medicines Agency
WEST HAVEN, CONNECTICUT -- Tuesday, September 3rd, 2013 -- NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that the European associates of the consulting firm Cote´ Orphan Consulting, on behalf of NanoViricides, have submitted an Orphan Drug Application to the European Medicines Agency (EMA) for DengueCide™, a 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 DengueCide orphan drug applications. The Company, in consultation with COC, has determined that its current lead DengueCide drug candidate is eligible for orphan drug status application in the European Union. The Company has recently received Orphan Drug Designation for DengueCide from the US FDA.
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 simulating antibody-dependent-enhancement (ADE) of dengue infection using a special laboratory mouse strain called AG129. ADE in humans is thought to lead to dengue hemorrhagic fever, and 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.
Interest in a treatment for dengue fever in Europe was confirmed today by the announcement that J&J has signed a collaboration with the Wellcome Trust and the University of Leuven in Belgium. http://www.wellcome.ac.uk/News/Media-office/Press-releases/2013/WTP053792.htm
Recently, thirteen European countries have reported 82 imported dengue cases including a major outbreak on the Portuguese island of Madeira. http://ecdc.europa.eu/en/publications/publications/communicable-disease-threats-report-31-may-2013.pdf. Dengue fever is considered an “orphan” disease by the EMA.
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.
(www.nanoviricides.com) is a development stage company that is creating special purpose nanomaterials for
antiviral therapy. The Company's novel nanoviricide® class of drug candidates are designed to specifically attack enveloped virus particles and to
dismantle them. The Company is developing drugs against a number of viral diseases including H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV,
oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among
This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could
differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other
written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933
and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and
unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially
affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these
forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these
forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ
materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and
elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory
authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of
principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and
obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and
market acceptance of our products.
Amanda Schuon, 310-550-7200