Jubilant Generics Limited (Jubilant), has entered into a non-exclusive Licensing Agreement with Gilead Sciences, Inc. that will grant Jubilant the right to register, manufacture and sell Gilead’s investigational drug, remdesivir, a potential therapy for Covid-19 in 127 countries including India.
These 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.
Jubilant Generics Limited is a subsidiary of Jubilant Life Sciences Limited, an integrated global pharmaceutical and life sciences company.
Under the licensing agreement, Jubilant will have the right to receive a technology transfer of the Gilead manufacturing process to scale up production to enable expedited access of the medicine to Covid-19 patients upon approvals by regulatory authorities in respective countries.
Shyam S. Bhartia, Chairman and Hari S. Bhartia, Co-Chairman & Managing Director, Jubilant Life Sciences Limited, said, “We are very happy to strengthen our partnership with Gilead to license 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.”
Remdesivir, an investigational antiviral therapy developed by Gilead, received Emergency Use Authorization (EUA) by USFDA to treat Covid-19. The EUA will facilitate broader use of remdesivir to treat hospitalized patients with severe COVID-19 disease.
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 ongoing to generate more data on the safety and efficacy of remdesivir as a treatment for COVID-19. Remdesivir remains an investigational drug and has not been approved by USFDA.
