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

NanoViricides, Inc. has entered into 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 assist in preparing and prosecuting orphan drug designation applications with the US FDA Office of Orphan Products Development. This strategic move follows preclinical data showing NV-387's strong activity in lethal animal models of orthopoxvirus infections, supporting its potential for orphan designations targeting smallpox, MPox, and measles.

Securing orphan drug status could provide NanoViricides with substantial regulatory and financial incentives, including tax credits for clinical trial expenses, exemptions from certain FDA user fees, and potentially up to seven years of market exclusivity upon approval. These benefits are particularly valuable for a clinical-stage company developing treatments for rare diseases, as they can significantly reduce development costs and create competitive advantages. The company's focus on orphan designations reflects a strategic approach to drug development that prioritizes areas of significant unmet medical need while optimizing regulatory pathways.

NV-387 represents NanoViricides' lead drug candidate, which the company plans to develop as a treatment for multiple viral infections including RSV, COVID-19, Long COVID, influenza, and other respiratory viruses in addition to poxvirus infections. The drug is based on the company's nanoviricide platform technology, which utilizes host-mimetic nanomaterials designed to combat viral infections through a novel mechanism of action. This technology platform originates from intellectual property licensed from TheraCour Pharma, Inc., with NanoViricides holding exclusive licenses for specific viral disease applications as detailed on their corporate website at https://www.nanoviricides.com.

The partnership with Only Orphans Cote comes as NanoViricides focuses on advancing NV-387 into Phase II human clinical trials. The company's broader pipeline includes development 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. While the orphan drug strategy represents a specific regulatory approach for certain indications, the company continues to pursue broader development pathways for NV-387 and other candidates across its portfolio.

NanoViricides' business model involves licensing technology from TheraCour Pharma for specific antiviral applications, with the company having obtained broad, exclusive, sub-licensable field licenses for drugs developed in several licensed fields. The company maintains a Memorandum of Understanding with TheraCour for developing drugs based on these technologies for all antiviral infections, though this agreement excludes cancer and similar diseases that may have viral origins but require different treatment approaches. As with all pharmaceutical development, the path forward involves substantial uncertainty, though the orphan drug strategy represents a calculated approach to navigating regulatory challenges while addressing serious medical needs.