NewsRamp is a PR & Newswire Technology platform that enhances press release distribution by adapting content to align with how and where audiences consume information. Recognizing that most internet activity occurs outside of search, NewsRamp improves content discovery by programmatically curating press releases into multiple unique formats—news articles, blog posts, persona-based TLDRs, videos, audio, and Zero-Click content—and distributing this content through a network of news sites, blogs, forums, podcasts, video platforms, newsletters, and social media.
FAQ: NanoViricides' Orphan Drug Strategy for NV-387 with Only Orphans Cote
TL;DR
NanoViricides' orphan drug strategy for NV-387 could secure tax credits, fee exemptions, and up to seven years of market exclusivity, offering a significant competitive advantage.
NanoViricides signed an agreement with Only Orphans Cote to develop an orphan drug strategy and prepare FDA applications for NV-387, which targets orthopoxvirus infections.
NV-387's potential orphan designations for Smallpox, MPox, and Measles could lead to new treatments for rare viral diseases, improving global health outcomes.
NanoViricides uses host-mimetic nanomedicine to create broad-spectrum antivirals, with NV-387 showing strong activity in lethal animal models of orthopoxvirus infections.
Found this article helpful?
Share it with your network and spread the knowledge!
NanoViricides, Inc. has signed a Master Services Agreement with regulatory consultant Only Orphans Cote to develop an orphan drug strategy for NV-387 and prepare orphan drug designation applications with the US FDA.
Only Orphans Cote is a regulatory consulting firm founded by Dr. Timothy Cote that will help NanoViricides develop its orphan drug strategy for NV-387 and prepare and prosecute related orphan drug designation applications at the US FDA Office of Orphan Products.
NV-387 is NanoViricides' lead broad-spectrum antiviral drug candidate that the company plans to develop as a treatment for RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections.
Orphan drug status may offer incentives including tax credits, user-fee exemptions, and up to seven years of market exclusivity, which can significantly benefit drug development for rare diseases.
NV-387 has shown strong activity in lethal animal models of orthopoxvirus infections, supporting its potential for Smallpox, MPox and Measles orphan designations.
The company is currently focused on advancing NV-387 into Phase II human clinical trials, though it cannot project an exact date for filing an IND due to dependence on external collaborators and consultants.
NanoViricides' business model is based on licensing technology from TheraCour Pharma Inc. for specific antiviral applications, using their nanoviricide™ platform technology based on host-mimetic nanomedicine for broad-spectrum antiviral therapy.
The company is developing drugs against oral and genital Herpes, viral eye diseases, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, Ebola virus, and has exclusive licenses for numerous other viral diseases.
To view the full press release, visit https://ibn.fm/2NRpu. For more information about NanoViricides, visit their website at www.nanoviricides.com.
Curated from InvestorBrandNetwork (IBN)
