NanoViricides, Inc. (NYSE American: NNVC) has signed a Master Services Agreement with regulatory consultant Only Orphans Cote, founded by Dr. Timothy Cote, to develop an orphan drug strategy for its antiviral candidate NV-387. The consultant will prepare and prosecute orphan drug designation applications at the US FDA Office of Orphan Products Development. This strategic move could provide significant regulatory and financial benefits for the clinical-stage company as it advances its pipeline.
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, granted for treatments of rare diseases affecting fewer than 200,000 people in the United States, offers incentives including tax credits for clinical trial expenses, exemptions from FDA user fees, and up to seven years of market exclusivity upon approval. These benefits can substantially reduce development costs and enhance commercial potential for pharmaceutical companies.
The company describes NV-387 as a broad-spectrum antiviral drug candidate based on its host-mimetic nanomedicine platform. According to company information available at https://www.nanoviricides.com, NanoViricides is currently focused on advancing NV-387 into Phase II human clinical trials for multiple indications including RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, in addition to MPOX/Smallpox infections. The company's platform technology originates from TheraCour Pharma, Inc., with which NanoViricides has licensing agreements for specific antiviral applications.
NanoViricides' business model involves licensing technology from TheraCour Pharma Inc. for specific application verticals targeting particular viruses. The company holds exclusive, sub-licensable licenses for several viral diseases including Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B and C, Rabies, Herpes Simplex Virus, Influenza, Dengue viruses, and Ebola/Marburg viruses. The company intends to obtain additional licenses for RSV, Poxviruses, and/or Enteroviruses if initial research proves successful.
The orphan drug strategy represents a focused approach to developing NV-387 for specific rare viral diseases while the company continues broader development efforts. This dual-path strategy allows the company to pursue both orphan and broader indications simultaneously, potentially creating multiple revenue streams if development proves successful. The engagement of specialized regulatory consultants like Only Orphans Cote, which focuses exclusively on orphan drug development, indicates a sophisticated approach to navigating complex regulatory pathways.
For investors following the company's progress, updates are available through the company's newsroom at https://ibn.fm/NNVC. The partnership announcement comes as NanoViricides continues developing drugs against numerous viral diseases including oral and genital Herpes, viral eye diseases, various influenza strains, and additional coronaviruses. As with all pharmaceutical development, the company notes that the path to drug approval is lengthy and capital-intensive, with no guarantee that any candidate will prove sufficiently effective and safe for human use despite promising laboratory results.
