In this March 2020 photo provided by Gilead Sciences, a vial of the investigational drug remdesivir is visually inspected at a Gilead manufacturing site in the United States. On Wednesday, April 29, 2020, the company says its experimental antiviral drug has proved effective against the new coronavirus in a major U.S. government study that put it to a strict test.
Four Indian companies including Cipla and Jubilant Life Sciences have signed an agreement with US drugmaker Gilead for the production of remdesivir, which is leading the pack for drugs considered as a potential treatment for coronavirus. As per the agreement, the drug remdesivir will be manufactured for distribution in 127 countries.
Gilead has stated that the list of 127 nations include nearly all low-income, lower middle-income and several upper-middle and high-income countries that face significant obstacles to healthcare access.
The non-exclusive voluntary licensing agreement has been signed with 5 generic drug makers out of which 4 are based in India while one is based in Pakistan. Indian companies include -- Cipla Ltd, Heteros Labs Ltd, Jubilant Life Sciences and Mylan. The sole Pakistani company included in the deal is Ferozsons Laboratories.
Remdesivir is a broad-spectrum antiviral medication developed by the biopharmaceutical company Gilead Sciences. The drug is being tested as a specific treatment for COVID-19, and has been authorized for emergency use in the U.S. and approved for use in Japan for people with severe symptoms.
The remdesivir clinical trial program was designed to answer multiple scientific questions in parallel, to rapidly evaluate the potential for remdesivir to treat COVID-19 patients. Gilead is conducting two randomized, open-label, multicenter, Phase 3 clinical studies to evaluate the safety and efficacy of two dosing durations – 5 days and 10 days – of remdesivir in adults diagnosed with COVID-19.
The first of the two SIMPLE studies are evaluating the safety and efficacy of both a 5-day and a 10-day dosing duration of remdesivir, in addition to standard of care, for patients with severe manifestations of COVID-19. Initial study results were announced on April 29. This study was planned to enrol 400 patients and was subsequently amended to enable the enrollment of an additional 5,600 patients in an expansion phase, including patients on mechanical ventilation. The study will enrol a total of 6,000 patients overall.
The second SIMPLE study is evaluating the safety and efficacy of the same dosing regimens of remdesivir in addition to standard of care for patients with moderate manifestations of COVID-19, compared with standard of care alone. This study was planned to enrol 600 patients and was subsequently amended to enable the enrollment of an additional 1,000 patients in an expansion phase. The study will enrol a total of 1,600 patients overall. Results from this study are expected at the end of May.
