Under terms of the licensing agreement, Jubilant will have the right to receive a technology transfer of the Gilead manufacturing process and can scale up production. This would, however, be subject to approvals by regulatory authorities in the respective countries.
India can also start using the drug on patients on compassionate grounds. The government was checking with pharma companies
on how soon the drug can be manufactured here for trials. Other drug makers from India are also estimated to be in the fray to sign licensing agreements.
Gilead had earlier indicated that it was working to build a global consortium to expand production of Remdesivir and make it available across countries. The drug, which is an injectable, got emergency approval from the US drug regulator recently. The trials show that patients administered with Remdesivir recover faster than others. However, Remdesivir remains an investigational drug and has not been approved by the USFDA.
Commenting on the partnership, Shyam S. Bhartia, chairman and Hari S. Bhartia, co-chairman & managing director (MD), Jubilant Life Sciences, said, “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. We will be monitoring the clinical trials and regulatory approvals very closely and would be ready to launch the drug shortly after the required approvals. We also plan to produce the drug’s active pharmaceutical ingredient (API) in-house, helping its cost effectiveness and consistent availability.”
Gilead is known for getting into licensing agreements with other drugmakers for its patented drugs – it did the same for its hepatitis C drug sofosbuvir earlier.
In pandemic situations, India can also invoke its Patents Act and grant compulsory licensing provision to allow third party manufacturing of a patented drug.