<p>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.</p>.<p>The agreement has been signed between Jubilant Life Sciences' subsidiary Jubilant Generics Ltd and Gilead, the company said in a regulatory filing.</p>.<p>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.</p>.<p>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.</p>.<p>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.</p>.<p>"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.</p>.<p>The company also plans to produce the drug's Active Pharmaceutical Ingredient (API) in-house, helping its cost effectiveness and consistent availability, they added.</p>.<p>Remdesivir, an investigational antiviral therapy developed by Gilead, received Emergency Use Authorization (EUA) by USFDA to treat COVID-19.</p>.<p>The EUA will facilitate broader use of remdesivir to treat hospitalized patients with severe COVID-19 disease, the filing said.</p>.<p>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.</p>.<p>"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.</p>.<p>However, remdesivir remains an investigational drug and has not been approved by USFDA, it added.</p>
<p>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.</p>.<p>The agreement has been signed between Jubilant Life Sciences' subsidiary Jubilant Generics Ltd and Gilead, the company said in a regulatory filing.</p>.<p>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.</p>.<p>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.</p>.<p>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.</p>.<p>"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.</p>.<p>The company also plans to produce the drug's Active Pharmaceutical Ingredient (API) in-house, helping its cost effectiveness and consistent availability, they added.</p>.<p>Remdesivir, an investigational antiviral therapy developed by Gilead, received Emergency Use Authorization (EUA) by USFDA to treat COVID-19.</p>.<p>The EUA will facilitate broader use of remdesivir to treat hospitalized patients with severe COVID-19 disease, the filing said.</p>.<p>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.</p>.<p>"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.</p>.<p>However, remdesivir remains an investigational drug and has not been approved by USFDA, it added.</p>