Jubilant Generics Limited, a subsidiary of Jubilant Life Sciences, has entered into a non-exclusive licensing agreement with Gilead Sciences for remdesivir, an investigational drug for treating coronavirus. The agreement allows Jubilant to register, manufacture and sell remdesivir in 127 countries, including India. This is the first voluntary licence for remdesivir.
"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," Jubilant Life Sciences told stock exchanges in a filing on Tuesday.
Remdesivir, an antiviral medicine developed by Gilead, has been received Emergency Use Authorisation (EUA) by USFDA 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.
The EUA facilitates broader use of remdesivir to treat hospitalised patients suffering from severe cases 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, the Jubilant Life Sciences statement said. Several additional clinical trials are ongoing to generate more data on the safety and efficacy of remdesivir as a treatment for COVID-19.
"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," said Shyam S Bhartia, Chairman and Hari S Bhartia, Co Chairman and Managing Director, Jubilant Life Sciences Limited, on the partnership with Gilead.