Cipla Limited has signed a non-exclusive licensing agreement with Gilead Sciences, Inc. for the manufacturing and distribution of the investigational medicine remdesivir, which has been issued an Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) to treat COVID-19 patients.



This agreement is part of Cipla's efforts to enhance global access to lifesaving treatments for patients affected by the pandemic.



As part of the agreement, Cipla will be permitted to manufacture the API and finished product, and market it in 127 countries including India and South Africa under Cipla's own brand name.



Cipla will receive the manufacturing know-how from Gilead Sciences, Inc. to manufacture the API and finished product at a commercial scale. Cipla's extensive geographical and commercial footprint will help make this therapy accessible to more patients and markets.



Meanwhile, Jubilant Life Sciences Limited, an integrated global pharmaceutical and life sciences company, has also announced that its subsidiary, Jubilant Generics Limited 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.



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.



Remdesivir, an investigational antiviral therapy developed by Gilead, received Emergency Use Authorization (EUA) by US FDA to treat COVID-19. The EUA will facilitate broader use of remdesivir to treat hospitalized patients with severe COVID-19 disease.



According to the World Health Organisation (WHO)'s tracker, the number of reported COVID-19 cases has crossed the four million mark globally.



The EUA will facilitate broader use of remdesivir to treat hospitalized patients with severe symptoms of COVID-19. The EUA is based on available data from two global clinical trials - US National Institute for Allergy and Infectious Diseases' placebocontrolled 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 potential treatment for COVID-19. Remdesivir continues to be an investigational drug that has not been approved by the FDA.



Umang Vohra, MD and global CEO, Cipla Limited said, "As the world is faced with the COVID-19 crisis, it is imperative that we collaborate and fight this virus together. We are pleased to partner with Gilead for this cause and take this treatment to patients across countries after the required regulatory approvals. At Cipla, it is our continuous endeavour to ensure that no patient is denied access to life-saving treatments. Our partnership with Gilead represents this unwavering commitment and is a significant step towards saving millions of lives impacted by the pandemic."



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.”