Indian drug company Jubilant Life Sciences on May 12 announced that its subsidiary Jubilant Generics Limited has entered into a non-exclusive agreement with Gilead Sciences to manufacture and sell remdesivir in 127 countries, including India.
Under the licencing agreement, the company have the right to receive technology transfer of the Gilead manufacturing process to scale up production to enable expedited access of the drug to COVID-19 patients upon approval by regulatory authorities in respective countries.
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Commenting on the partnership, Shyam Bhartia and Hari Bhartia, Co-Chairman and Managing Director, Jubilant Life Sciences said, “We are very happy to strengthen our partnership with Gilead to licence remdevisir, which, based on initial data shows promise to be a potential therapy for coronavirus, 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 it cost effectiveness and consistent availability”.
Last week, Gilead said it was in talks with several chemical and drug makers, including in India, to produce its experimental COVID-19 drug remdesivir for Europe, Asia and the developing world through at least 2022.Interest in remdesivir has been high globally because there are no approved treatments or vaccines for COVID-19, the respiratory illness caused by the new coronavirus and several countries are reeling from the virus outbreak.
Gilead last week received the US Food and Drug Administration’s emergency use authorisation for using remdesivir as a treatment against COVID-19, after it provided data showing the drug had helped COVID-19 patients.
The drug has received Emergency Use Authorization (EUA) from USFDA to treat COVID-19, which allows broader use of remdesivir to treat hospitalized patients with severe COVID-19 disease. The EUA was based on the available data from two global clinical trials – US National Institute of Allergy and Infectious Diseases’ placebo-controlled phase 3 study in patients with moderate to severe symptoms of the COVID-19, and Gilead’s global phase 3 study evaluating the drug in patients with severe symptoms of COVID-19.
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