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NanoViricides Files Orphan Drug Application with the FDA for DengueCide

NanoViricides, Inc. (the "Company") announced today that it has filed an Orphan Drug application with the Office of Orphan Product Development (OOPD) of the US FDA for DengueCide™, its 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 orphan drug application. The Company, in consultation with COC, has determined that its current lead DengueCide™ drug candidate is eligible for orphan drug status application in the USA.

DengueCide is a nanoviricide® that has shown very high effectiveness in animal models of dengue virus infection and also in cell culture studies of dengue virus infection. These animal studies as well as cell culture studies were conducted in the laboratory of Dr. Eva Harris, Professor of Public Health and Infectious Diseases at the University of California, Berkeley. Prof. Harris found that the special laboratory mouse strain AG129 infected with a dengue virus in a lethal challenge ADE-simulation protocol, when left untreated, suffered a 100% fatality rate. In contrast, in the same study, animals treated with NanoViricides' DengueCide achieved an unprecedented 50% survival rate.

Dengue and dengue hemorrhagic fever have been designated as orphan drug status eligible diseases in the USA. Orphan Drug designation enables several benefits to promote drug development that include tax credits and an extended exclusive marketing period upon drug approval. These benefits provide significant financial incentives for developing orphan drugs. However, there can be no assurance that DengueCide will be granted an orphan drug designation.

In addition to the incentives related to orphan drug status, the Company may be eligible to receive a Priority Review Voucher (PRV) in the USA, upon approval of a drug against dengue viruses. A PRV can be applied by the Company to another drug candidate to obtain a “priority review” to speed up the regulatory process for that other drug. A PRV can also potentially be sold to another pharmaceutical company to obtain an immediate financial benefit. The value of a PRV has been variously estimated to be between $200M to $600M for such transactions.

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.

Tim Cote´, MD, MPH, was the Director of the Office of Orphan Product Development (OOPD) at the FDA, from 2007 to 2011. In this role heading OOPD at the Agency, he was responsible for the implementation of the Orphan Drug Act, a system of grants and drug development incentives designed to create therapies for 6,000+ rare diseases. After leaving the US FDA, Dr. Cote´ served as the Chief Medical Officer (CMO), National Organization for Rare Disorders (NORD), Washington, DC. He has held several other illustrious positions with increasing responsibilities during his career, including CDC Country Director for Rwanda, Senior Research Investigator in the Viral Epidemiology Branch of the National Cancer Institute, and Branch Chief, Therapeutics and Blood Safety, CBER, FDA. In addition to his role as the Principal at COC, Dr. Cote´ is currently Professor of Regulatory Practice at the Keck Graduate Center, Claremont, CA.

About Dengue and Dengue Hemorrhagic Fever

Dengue fever, a very old disease, has reemerged in the past 20 years with an expanded geographic distribution of both the viruses and the mosquito vectors, increased epidemic activity, the development of hyper-endemicity (the co-circulation of multiple serotypes), and the emergence of dengue hemorrhagic fever in new geographic regions. In 2013, this mosquito-borne disease is one of the most important tropical infectious diseases globally, with an estimated 400 million cases of dengue fever, over one million cases of dengue hemorrhagic fever, and 50,000-100,000 deaths annually. Dengue virus occurs in four primary serotypes.

A potentially life-threatening dengue disease due to “antibody-dependent enhancement of infection (ADE)” occurs when a patient is infected with a different serotype of dengue virus after the patient’s immune system was “primed” by a previous dengue virus infection. ADE increases the propensity to develop dengue hemorrhagic fever, or dengue shock syndrome, with a high fatality rate. Dengue viruses are carried by mosquitoes that serve as the vectors for the disease. The disease is endemic in many tropical parts of the world, although it is considered an orphan disease in the USA and Europe. (From Clinical Microbiology Reviews).

Priority Review Voucher

A “Priority Review Voucher” is an incentive for companies to invest in new drugs and vaccines for neglected tropical diseases. A provision of the Food and Drug Administration Amendments Act (HR 3580) awards a transferable “priority review voucher” to the company that obtains approval for a treatment for a neglected tropical disease including dengue.

NanoViricides Pipeline

NanoViricides is developing broad-spectrum anti-influenza drugs as part of its rich drug pipeline. The Company believes that its FluCide™ drug candidates will be effective against most if not all influenza viruses, including the H7N9 bird flu, H3N2 or H1N1 epidemic viruses, H5N1 bird flu, seasonal influenzas, as well as novel influenza viruses. This is because FluCide is based on the Company’s biomimetic technology, mimicking the natural sialic acid receptors for the influenza virus on the surface of a nanoviricide® polymeric micelle. It is important to note that all influenza viruses bind to the sialic acid receptors, even if they rapidly mutate. The FluCide drug candidates have already shown strong effectiveness against H1N1 and H3N2 influenza viruses in highly lethal animal models. In addition, earlier candidates were shown to be effective against two different strains of H5N1 viruses in cell cultures. In a highly lethal animal model, the injectable FluCide drug candidates have shown 1,000X greater viral load reduction as compared to oseltamivir (Tamiflu®), the current standard of care. The small animal serves only as a “test tube” because FluCide is designed to attack the influenza virus directly and does not depend upon the host or its defenses. Thus the Company believes that these animal model results should translate readily into humans.

NanoViricides has also developed an oral drug candidate against influenza. This oral version is also dramatically more effective than TamiFlu in the animals given a lethal influenza virus infection. This oral FluCide may be the very first nanomedicine that is effective when taken by mouth.

In addition, NanoViricides has developed drug candidates against Dengue, HIV/AIDS, Herpes, and Ocular Viral Diseases that have shown strong effectiveness in relevant animal and/or cell culture models.

An orphan designation for our dengue drug candidate, if granted, is expected to help the Company assign a higher priority to its dengue drug program, and undertake rapid development following the influenza drug candidates.



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