COVID-19: Jubilant Life inks licensing agreement with Gilead for remdesivir

Jubilant Life Sciences Ltd on Tuesday said it has entered into a non-exclusive licensing agreement with Gilead Sciences, Inc that will grant it the right to register, manufacture and sell the latter's investigational drug, remdesivir, a potential therapy for COVID-19, in 127 countries including India.

The agreement has been signed between Jubilant Life Sciences' subsidiary Jubilant Generics Ltd and Gilead, the company said in a regulatory filing.

Under the licensing agreement, Jubilant will have the right to receive technology transfer of 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.

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, it added.

Commenting on the partnership,Jubilant Life Sciences Chairman Shyam S Bhartia and Co-Chairman & Managing Director Hari S. Bhartia said that based on initial data, remdesivir 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," they said.

The company also plans to produce the drug's Active Pharmaceutical Ingredient (API) in-house, helping its cost effectiveness and consistent availability, they added.

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 filing said.

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," the filing said.

However, remdesivir remains an investigational drug and has not been approved by USFDA, it added.