The move follows the release of preliminary trial results, which indicated Remdesivir can successfully treat serious cases of Covid-19.
US-drug manufacturer Gilead Sciences has signed non-exclusive voluntary licencing agreements with five generic pharmaceutical companies in India and Pakistan to manufacture and distribute the investigational medicine, Remdesivir, to 127 countries. The manufacturers include Cipla, Ferozsons Laboratories, Hetero Labs, Jubilant Life Sciences and Mylan. Most low-income and lower-middle income as well as several upper-middle and high-income countries face significant obstacles to make quality healthcare accessible to all.
Under the licencing agreements, the companies have a right to receive a technology transfer of the Gilead manufacturing process for Remdesivir to enable them to scale up production more quickly. “The licensees also set their own prices for the generic product they produce. The licences are royalty-free until the World Health Organization declares the end of the Public Health Emergency of International Concern regarding Covid-19 or until a pharmaceutical product other than Remdesivir or a vaccine is approved to treat or prevent Covid-19, whichever is earlier,’’ a company statement said.
The move follows the release of preliminary trial results, which indicated Remdesivir can successfully treat serious cases of Covid-19. The disclosure prompted the US Food and Drug Administration (USFDA) to quickly authorise its emergency use for hospitals. For the moment, Gilead plans to eventually donate 1.5 million doses, which could cover between 1,40,000 and 280,000 patients, depending on dosing. However, it is unclear the extent to which Remdesivir may become a standard of care, since full study results have not yet been released.
Gilead decided to build a consortium of manufacturing partners to maximise global supply. Producing the drug requires scarce raw materials, with their own lengthy production time, and specialised manufacturing capabilities, with limited global capacity. Any disruption to the supply chain impacting these scarce raw materials and other manufacturing inputs could reduce the amount of Remdesivir produced and increase the production time.
The Emergency Use Authorisation (EUA) will facilitate broader use of Remdesivir to treat hospitalised patients with severe symptoms of Covid-19. The EUA is based on available data from two global clinical trials — US National Institute for Allergy and Infectious Diseases’ placebo-controlled phase-3 study in patients with moderate to severe symptoms of Covid-19 and Gilead’s global phase-3 study evaluating Remdesivir in patients with severe disease. Multiple additional clinical trials are being conducted to generate more data on the safety and efficacy of Remdesivir as a potential treatment for Covid-19. It continues to be an investigational drug that has not been approved by the FDA.
“Hetero has developed this product in India and has already been working with the government, ICMR and DCGI for necessary studies and approvals to bring this product to treat Covid-19 patients in India,” B Partha Saradhi Reddy, chairman, Hetero group, said. The company is one of the world’s largest producer of anti-retroviral drugs. “We will be monitoring the clinical trials and regulatory approvals very closely and would be ready to launch the drug shortly after the required regulatory approvals. We also plan to produce the drug’s API in-house, helping its cost effectiveness and consistent availability,” said Shyam S Bhartia, chairman of Jubilant Life Sciences, with co-chairman and managing director Hari S Bhartia seconding his views.
Following intense criticism from civil society groups, Gilead gave up a special designation from the USFDA that would have allowed for extended monopoly control over the 20-year patents it has filed for in more than 70 countries for Remdesivir.