New Delhi: Jubilant Life Sciences Tuesday became the first Indian company to announce a licensing agreement with US-based Gilead Sciences to manufacture remdesivir, an experimental drug that has reportedly shown promise in treating Covid-19.
The Noida-based company made the announcement through a press statement.
Under their agreement, Jubilant said, the company will receive a technology transfer of the Gilead manufacturing process to scale up production of remdesivir and enable expedited access to the medicine in over 100 countries, including India, following approvals by the respective regulatory authorities.
“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,” chairman Shyam S. Bhartia and co-chairman and managing director Hari S. Bhartia said in the statement.
“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 added. “We also plan to produce the drug’s Active Pharmaceutical Ingredient (API) in-house, helping its cost effectiveness and consistent availability.”
Jubilant Life Sciences has established the licensing agreement through its subsidiary Jubilant Generics Limited. The “non-exclusive licensing agreement” will allow Jubilant the right to register, manufacture and sell remdesivir in 127 countries.
According to the press statement, “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”.
“Remdesivir remains an investigational drug and has not been approved by US FDA,” the press release stated.
The Modi government had last week held a video conference with top pharmaceutical companies, including Jubilant, to check the “status” of the drug’s development in India.
The drug, brand named as Veklury, is under patent protection until 2035.
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Experimental drug has ‘clear cut’ effects
Remdesivir, an investigational antiviral therapy developed by Gilead, has reportedly shown “clear-cut” positive effects in treating Covid-19, which has killed over 2.7 lakh people around the world.
Last month, Dr Anthony Fauci, an adviser to US President Donald Trump, said data had shown that “remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery”.
Later, the drug received an emergency use authorisation (EUA) from the US drug regulator, the Food and Drug Administration (FDA), to treat Covid-19.
The EUA is based on available data from two global clinical trials – a placebo-controlled Phase 3 study in patients with moderate to severe symptoms of Covid-19, conducted by US National Institute for Allergy and Infectious Diseases, and Gilead’s global Phase 3 study evaluating the effects of remdesivir in patients with severe disease.
Patients who were administered the drug, Fauci said, were discharged from the hospital in 11 days, on average, as compared to 15 days for a placebo group, which took dummy or no pills.
However, multiple additional clinical trials are underway to generate more data on the safety and efficacy of remdesivir as a treatment for Covid-19. It’s also part of the WHO’s “Solidarity Trials”.
Also Read: Japan is set to approve remdesivir to treat coronavirus