Russia’s Direct Investment Fund (RDIF), an active participant in funding the development of therapies and vaccines for that nation in response to the pandemic, recently put a halt on exports of that country’s generic version of the antiviral drug favipiravir known under the trade name Avifavir. The first such Favipiravir-based drug approved to treat COVID-19, Avifavir is actually the third Favipiravir-based product authorized in Russia for targeting early onset mild to moderate COVID-19. As with Russia, multiple companies in India market Favipiravir-based products targeting COVID-19. With the upswing in COVID-19 cases driven by the second wave of the pandemic, demand soared for the product, according to the RDIF. Consequently, the Russian financial representative now halts all exports, allowing distribution only within Russia until the manufacturers can ramp up further capacity and surplus product to catch up with demand. Thus far, they have exported the drug to 15 nations.
Authorization in Russia
The first Russian-made variety of Favipiravir, known as Avifavir, was registered (approved) by the Russia Ministry of Health on May 29, 2020. The drug was made possible by a deal bringing together the Russia Direct Investment Fund (RDIF) led by its charismatic, Harvard and Stanford trained executive, Kirill Dmitriev and Russian pharmaceutical company ChemRar Group.
That move was made based on what the sponsor claimed was transparent clinical trials data from a number of studies. It became the very first Favipiravir-based treatment for COVID-19. The Russians reported that the drug’s efficacy was evidenced in 408 patients with confirmed coronavirus participating in the studies conducted at 35 medical centers across Russia. The total number of patients rose to 460 by October.
Confirmation by Favipiravir Maker but No Japanese Approval Yet
Five months after the Russian move, the original developer of Favipiravir, Japan’s Fujifilm Toyama Chemical Ltd. (Fujifilm) reported positive data resulting from a Phase 3 clinical trial. Apparently the administration of the favipiravir-based drug Avigan to 156 patients demonstrated shorter time to resolution as compared to a placebo group. Interestingly, Fujifilm is struggling to get the Japanese health authorities to approve the drug in the maker’s home nation of Japan. Although, they submitted their application for market authorization back in October.
Russia’s Second Wave
As the second wave of the pandemic swept around the world, Russia emerged as the country with the fourth-largest number of COVID-19 infections worldwide behind the USA, India and Brazil. With over 3 million cases now, nearly 55,000 have died in Russia.
This second spike in severity has led to strains on the health system, including hospitals operating near or at capacity as well as growing imports of various drugs and treatments.
Hence by November Reuters reported growing shortages and tensions across Russia. This undoubtedly led to the intense demand and the most recent halt on exports.
Doubling Production Capacity
Apparently, Mr. Dmitriev told Russian television (Rossiya 24 broadcaster) that they had to stop exports to ramp up further product production. Together, RDIF and ChemRar Group formed Chromis, a manufacturing unit to produce Avifavir. Last month in Nov., ChemRar Group disclosed it would double production to produce 200,000 packs of the drug per month. The supply of the product had to catch up with the demand.
Lots of Exports
Back in Sept., the RDIF and ChemRar were roaring forward with exports, undoubtedly driving significant revenue along the way. They reported that over a dozen countries were on the list receiving the favipiravir-based product from Russia. These reports are based on Russian accounts and cannot confirm the credibility nor the accuracy of the underlying data. The press there much like in many places can actually represent biased agendas.
U.S. POTUS Push back in Spring
Apparently back in late March Politico reported that the Trump Administration sought to encourage the FDA and others to support the emergency approval of the decades-old flu drug as a possible COVID-19 treatment. Although championed by Japanese Prime Minister Shinzo Abe as well as Chinese scientists praising the drug, U.S. researchers and scientists expressed concern about risks associated with the drugs such as birth defects and warned that the data deriving from Chinese studies weren’t sufficient, reported Politico.
Interestingly TrialSite reported that the U.S. government via the DoD had spent over $200 million on Phase 3 clinical trials involving Favipiravir just five years ago.
But given the Hydroxychloroquine debacle and the slow going of Favipiravir studies in America there hasn’t been much press on the topic. TrialSite reported recently that generic drug maker Dr. Reddy’s along with Appili Therapeutics quietly submitted the drug for approval with Health Canada. TrialSite asked the question: Why did they have to do it quietly?