As we recently reported, here and here, Favipiravir is an up-and-coming COVID-19 treatment around the world. Given over $200 million has been spent by the U.S. Department of Defense on this drug, it is oddly lacking in approval and current research by the U.S. The Austin Journal of Public Health Epidemiology looked into the drug in the June article “Favipiravir and USA.” They note that it “was invented as the most useful drug for bioengineered pandemics.” And while first developed in Japan, it has garnered lots of interest from the Department of Defense. U.S. trials started in 2014 and completed in 2015, but there has been no FDA approval or market authorization. AJPHE’s author sought the answer and, “wrote to FDA twice, only to know that it is not possible to know anything because of federal confidentiality (personal communication).”
In a 2015 Phase 3 Favipiravir clinical trial report, the sponsor is listed as MDVI, LLC; and MediVector, Inc is noted as a collaborator. MediVector is well-known as the Department of Defense’s research partner for this drug, but MDVI is a bit more mysterious: “This company has no/unclaimed website.” DoD initially gave MediVector $139 million for research, and they began two late-stage trials with over 1,000 patients. The research aimed to “help bolster the protection of the Joint Forces against naturally occurring pandemic influenza and/or biologically engineered flu viruses.” After a 2015 “maximum $9,135,695 modification,” the total spent by DoD was $211,303,678. The Phase 3 trial report says, “No Study Results Posted on ClinicalTrials.gov for this Study.” So there was no FDA approval, no manufacturing, and no Favipiravir in the market. Quoting the AJPHE, “The whole thing is in such a mess that it needs urgent investigation. Moreover, the biggest unanswered question is where had the money gone.”
Deep Defense Ties: Doctor, Lawyer, Soldier, CEO
Global BioDefense looked into Favipiravir back in 2016. They noted that “Favipiravir is being developed by BioDefense Therapeutics (BD Tx), a Joint Product Manager within the Medical Countermeasure Systems (JPM-MCS) Joint Project Management Office. A component of the Joint Program Executive Office for Chemical and Biological Defense, JPM-MCS aims to provide U.S. military forces and the nation with safe, effective, and innovative medical solutions to counter chemical, biological, radiological and nuclear threats.”
Currently, Dr. Armand Balboni is the CEO of Canada’s Appili Therapeutics, and that firm is now collaborating with Fujifilm on Favipiravir development. Balboni “is also a Commissioned Officer in the U.S. Army with 17 years of military service including as the Deputy Director, Office of Regulated Activities (ORA), U.S. Army Medical Materiel Development Activity (USAMMDA)…. He also served as the Chief, Office of Research and Technology Application (ORTA), at the U.S. Army Research Institute of Infectious Disease (USAMRIID). Under his leadership, this office was responsible for the oversight of all strategic partnerships between USAMRIID and universities, U.S. and foreign government agencies, and biotechnology and pharmaceutical companies…. He completed his doctoral work in the MD/PhD program at the Icahn School of Medicine at Mount Sinai and his law degree (JD) at Brooklyn Law School.” In its 2020 report, Appili noted “a $3M USD grant from the U.S. Department of Defense,” so the military-pharma connection continues. TrialSite News wonders about the contradiction between the deep U.S. government involvement in Favipiravir and the lack of both FDA approval and production by U.S. firms, and we will continue to report on this story.