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Monday, 12 August 2013
NanoViricides extends gains as it gets orphan drug status in the U.S. for DengueCide candidate
NanoViricides (OTCBB:NNVC) says its DengueCide drug candidate, for treating the mosquito-borne dengue virus, has officially been designated an orphan drug by the U.S. FDA.
The status qualifies the company for certain tax credits and marketing incentives under the Orphan Drug act. In addition, it will qualify for the waiver of certain FDA fees when it files the new drug application for DengueCide, and will be eligible for a priority review voucher -- which aims to render a decision in six months -- from the U.S. regulatory agency when it files the application.
Last month, NanoViricides was notified that clinical coordinators in Europe were appointed to review the company's upcoming orphan drug application for DengueCide in that region.
"Now we intend to accelerate our dengue drug development programs to take advantage of these benefits," said Dr. Eugene Seymour, CEO of the company.
DengueCide, which is in pre-clinical development stage, still has to go through the human trial stage, which requires the FDA's approval of an investigational new drug application. If the human trials are successful, then the company must file a new drug application to achieve marketing status.
NanoViricides, which has six commercially important drug candidates in its pipeline that together address a market size of greater than $40 billion, says DengueCide has shown "very high effectiveness" in animal studies, in the U.S. Indeed, in the mouse study conducted at the University of California, those mice treated with DengueCide achieved a 50 per cent survival rate, as opposed to a 100 per cent fatality rate when left untreated.
There is currently no drug treatment or vaccine for the dengue virus, with the orphan drug designation to help the company give the DengueCide drug a higher priority and move it forward rapidly following the development of its flu treatment.
Dengue fever is an old disease that has re-emerged in the past 20 years, with an estimated 400 million cases of the tropical infectious disease in 2013 and between 50,000 to 100,000 deaths annually.
NanoViricides, which has six commercially important drug candidates in its pipeline that together address a market size of greater than $40 billion, is focused first on bringing its FluCide drug candidate to market. It currently has both an oral and injectable version of FluCide, which has the potential to wipe out virtually all strains of the pesky influenza A virus. The company is now preparing for toxicology studies for its first FluCide candidate, expected to be wrapped up before the middle of next year.
NanoViricides reached a new 52-week high last week, a matter of days after the news that the Connecticut-based nano-biopharmaceutical company had signed a non-disclosure agreement with the Lovelace Respiratory Research Institute with the intent of furthering its plan to conduct drug studies of both its broad-spectrum injectable and oral FluCide candidates. It anticipates inking a master services agreement with private biomedical research organization Lovelace, for the efficacy studies to be conducted in advance of the investigational new drug (IND) application.
The news follows the recent execution of another NDA with the UK Public Health Agency for the testing of its FluCide candidate against the A/H7N9 strain as well as new drug candidates against the emerging MERS virus.
Shares of the company were trading higher in early deals, up almost one per cent at $1.17, extending year-to-date gains to almost 150 per cent.