As COVID-19 continues to spread across global regions, the quest for therapeutics to treat both mild/moderate as well as severe infections continues with high intensity. In addition to antibody therapies, repurposed antivirals are at the forefront of this effort. In a move that can expand to a potential therapy, leading Indian pharma company Dr. Reddy’s has partnered with Japanese innovator, Fujifilm Toyama as well as Dubai based Global Response Aid (GRA) for manufacturing, development and sales of the generic version of Avigan (favipiravir) for treatment of COVID-19. Under the agreement, Fujifilm has granted both Dr. Reddy’s and GRA the rights to develop and sell the drug overseas excluding Japan, China and Russia for an undisclosed amount of upfront license fee and royalties on sales. Dr. Reddy’s also enjoys exclusivity for manufacturing and selling the drug in India.
Dr. Reddy’s and GRA will both have access to preclinical and clinical data generated so far to support further clinical studies. Dr. Reddy’s will also obtain the rights to use Aviagen’s patents on formulation and the manufacturing process. Combined with GRA’s global sales network, the partners hope that this development will accelerate global accessibility to the drug.
Avigan, originally approved in Japan as an influenza antiviral drug, halts functioning of RNA polymerase which is critical for viral replication and hence limits virus propagation. While researchers are anticipating that the drug can possibly have a similar antiviral response towards SARS-CoV-2 and are clinically investigating this hypothesis, Favipiravir has already been approved on an emergency basis as a therapeutic for COVID-19 in several countries including, China, Italy, Russia and recently in India as well. Fujifilm’s anti-COVID-19 drug oral candidate, T-705 is currently undergoing phase III study in Japan and a phase II study in the USA. The phase III study in Japan slowed down as the number of cases in the country dipped significantly. While data from the trials is yet to demonstrate safety and efficacy of the drug against COVID-19, Fujifilm had ramped up their production of the investigational drug, which Government of Japan had planned to stockpile.
Currently, a few independent trials have reported clinical benefit of favipiravir for COVID-19. However, there has been no data published yet from large trials, increasing the uncertainty around use of the drug against novel coronavirus, SARS-CoV-2. While expanding access to this antiviral is encouraging, there is a great need for clinical validation with rigor to drive wider acceptance amongst medical professionals and consequent clinical outcomes.