NanoViricides (NYSE-A:NNVC) CEO Dr. Anil Diwan talked with Proactive about the company’s recent FDA application for rare pediatric disease designation for its antiviral candidate NV-387, highlighting both the scientific and commercial implications of the move.
Diwan explained that the reinstated FDA program provides an opportunity to secure a Priority Review Voucher (PRV) upon approval, which could significantly accelerate development timelines or be monetized.
The discussion also covered how NV-387 is being developed with a focus on measles, an area with no approved antiviral treatments. NanoViricides has already submitted for orphan drug designation and is now pursuing additional regulatory pathways to speed up progress.
Diwan emphasized that these designations can lead to increased FDA engagement, including more frequent meetings and faster development timelines.
He also pointed to growing measles concerns in the United States, including vulnerable populations such as infants and individuals who do not respond effectively to vaccines. Even among vaccinated individuals, breakthrough infections can occur, reinforcing the need for therapeutic options.
Proactive: All right, welcome back inside our Proactive newsroom. And joining me now is Dr. Anil Diwan, CEO of NanoViricides. Dr. Diwan, it's great to see you again. How are you?
Dr. Anil Diwan: I'm fine. Great to see you, too.
Exciting news from the company — you've submitted an FDA application for rare pediatric disease designation for NV-387, with measles as one target. What would this designation mean?
The rare pediatric disease program was initiated by Congress and had lapsed, but it was recently reinstated. We took advantage of that and filed. This opens up the opportunity to receive a Priority Review Voucher (PRV) when the drug is approved.
PRVs can be used to accelerate development of the same or other drugs, or sold to third parties. That creates a strong financial incentive. As a small company, we are very interested in that benefit. PRVs have historically sold for as much as $250 million, with recent prices around $150–$160 million.
This creates a strong business case because the benefit comes at the time of drug approval, unlike traditional commercialization where revenues come later.
It also helps accelerate your timeline, correct?
Yes. We have already applied for orphan drug designation for measles, and these programs together can accelerate development. We expect more FDA attention, more frequent meetings, and faster progress.
After successful animal studies in humanized mouse models for measles, where our drug performed extremely well, we have been preparing for FDA filings and pursuing these designations to support accelerated timelines.
There are currently no approved antiviral treatments for measles. Does that unmet need play a role?
Exactly. Measles has been resurging in the United States. Some populations do not respond well to vaccines, infants cannot be vaccinated early, and breakthrough infections occur in about 10% of vaccinated individuals.
When someone gets the disease, they need treatment.
Quotes have been lightly edited for style and clarity