NanoViricides Partners with Regulatory Consultant to Pursue Orphan Drug Strategy for Antiviral Candidate NV-387

NanoViricides, Inc. has signed a Master Services Agreement with regulatory consultant Only Orphans Cote to develop an orphan drug strategy for its lead antiviral candidate NV-387. The agreement involves OOC preparing and prosecuting orphan drug designation applications at the US FDA Office of Orphan Products Development. This regulatory partnership represents a strategic move to potentially accelerate and enhance the development pathway for NV-387 by pursuing orphan drug designations that could provide financial and regulatory benefits supporting treatments for rare viral diseases that might otherwise receive limited pharmaceutical investment.

The company stated that NV-387 has demonstrated strong activity in lethal animal models of orthopoxvirus infections, supporting its potential for orphan designations targeting Smallpox, MPox, and Measles. Orphan drug status offers pharmaceutical companies several incentives including tax credits for clinical research, exemptions from certain FDA user fees, and up to seven years of market exclusivity upon approval. These benefits are particularly important for a clinical-stage company like NanoViricides as it advances its antiviral pipeline through the lengthy and capital-intensive drug development process.

NV-387 represents NanoViricides' lead drug candidate, which the company plans to develop as a treatment for multiple viral infections including RSV, COVID, Long COVID, Influenza, and other respiratory viral diseases. The company's technology platform is based on intellectual property licensed from TheraCour Pharma, Inc., with NanoViricides holding exclusive worldwide licenses for several viral disease applications. According to their business model detailed on their comprehensive corporate website at https://www.nanoviricides.com, NanoViricides licenses technology from TheraCour Pharma for specific application verticals targeting particular viruses, as established when the company was founded in 2005.

Beyond NV-387, NanoViricides is developing other antiviral candidates including NV-HHV-1 for Shingles treatment and has research programs targeting numerous viral diseases such as oral and genital Herpes, viral eye diseases, various influenza strains, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus. The company holds perpetual licenses for TheraCour's nanomedicine technology for specific viral diseases including Human Immunodeficiency Virus, Hepatitis B and C viruses, Rabies, Herpes Simplex Virus, Varicella-Zoster Virus, Influenza, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses.

The company noted that it intends to obtain additional licenses for RSV, Poxviruses, and/or Enteroviruses if initial research proves successful. NanoViricides is currently focused on advancing NV-387 into Phase II human clinical trials, though the company acknowledges it cannot project exact dates for filing Investigational New Drug applications due to dependence on external collaborators and consultants. The partnership with Only Orphans Cote, founded by Dr. Timothy Cote, provides specialized regulatory expertise that could streamline the orphan designation process, potentially bringing treatments for rare viral infections to market more efficiently while leveraging the financial advantages of orphan drug status to support continued research and development efforts across the company's broad antiviral portfolio.