Four Indian companies, including Cipla, Jubilant, Hetero and the domestic arm of Mylan, have signed non-exclusive voluntary licencing agreements with the United States-based Gilead Sciences to manufacture and supply generic versions of Gilead's potential COVID-19 drug Remdesivir. Ferozsons Laboratories of Pakistan is also part of the five-country global partnership Gilead has announced to sell Remdesivir in 127 countries.
The countries consist of nearly all low-income and lower-middle-income countries as well as several upper-middle- and high-income countries that face significant obstacles to healthcare access.
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 licencees can also set their prices for the generic product they produce. The licences are royalty-free until the World Health Organisation 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, Gilead has stated.
In a stock exchange filing, Jubilant Life Sciences said it's subsidiary Jubilant Generics Ltd has entered into the partnership agreement. "We are very happy to strengthen our partnership with Gilead to licence Remdesivir, which, based on initial data, shows promise to be a potential therapy for COVID-19, a pandemic creating unprecedented health and economic crisis globally. 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 Active Pharmaceutical Ingredient (API) in-house helping its cost-effectiveness and consistent availability," said Shyam S Bhartia, Chairman and Hari S Bhartia, Co-Chairman and Managing Director, Jubilant Life Sciences Limited.
Remdesivir has received Emergency Use Authorisation (EUA) by the US Food and Drug Administration to treat COVID-19. It, however, remains an investigational drug and has not been approved by the US drug regulator as a cure against coronavirus as yet.