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FDA授予登革热纳米抗病毒药物DengueCide孤儿药地位

来源:生物谷 2013-08-13 14:15

2013年8月13日讯 /生物谷BIOON/ --NanoViricides公司8月12日宣布,FDA已授予实验性药物DengueCide孤儿药地位,该药开发用于登革热(dengue)及登革出血热(dengue hemorrhagic fever)的治疗。同时,在提交DengueCide新药申请(NDA)时,将有资格获得优先审查资格。

DengueCide是一种纳米抗病毒候选药物(nanoviricide),在登革热病毒感染动物模型中已表现出非常高的有效性。相关动物试验在美国加州大学伯克利分校教授Eva Harris博士实验室完成。Harris博士利用一种特殊的名为AG129的小鼠品系,开发出了一种抗体依赖性增强(antibody-dependent-enhancement,ADE)登革热感染小鼠模型,能够模拟登革出血热(DHF/DHSS)。

在动物实验中,未治疗组小鼠死亡率达100%,DengueCide治疗组达到了前所未有的50%存活率。(生物谷Bioon.com)

英文原文:NanoViricides Announces that DengueCide? Has Received Orphan Drug Designation From the US FDA

WEST HAVEN, CONNECTICUT -- August 7th 2013 -- NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that DengueCide?, its drug candidate for the treatment of dengue and dengue hemorrhagic fever, has been officially designated as an orphan drug by the US FDA.

This 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 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.

“Now we intend to accelerate our dengue drug development programs 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).

The Company has already filed a letter of intent as required for filing of an orphan drug designation application for DengueCide with the European Medicines Agency (EMA). A committee has already been established by the EMA to perform the evaluation. The criteria employed for orphan drug designation at the EMA are somewhat different from those employed by the US FDA. The benefits of an EMA orphan drug designation are different from those of the US FDA orphan designation. There is no guarantee that the Company will receive an orphan designation for DengueCide under the EMA.

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 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. 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 . 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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