Remdesivir to be made in India as 3 firms get nod from US drug-maker for generic version
New Delhi: American drug-maker Gilead late Tuesday announced signing voluntary licensing agreements with three Indian pharmaceutical companies to expand the supply of remdesivir — an experimental drug that has shown promise in treating Covid-19.
The ‘non-exclusive’ agreements allow Cipla, Hetero Labs and Jubilant Lifesciences to manufacture remdesivir. The US firm has also allowed one drug-maker based in Pakistan, Ferozsons Laboratories, and the Pennsylvania-based Mylan to manufacture the drug. In all, the five companies will produce the drug for distribution in 127 countries.
The five companies have also been allowed to set their own prices for the generic product.
“The licenses are royalty-free until the World Health Organization declares the end of the Public Health Emergency of International Concern regarding COVID-19, or until a pharmaceutical product other than remdesivir or a vaccine is approved to treat or prevent COVID-19, whichever is earlier,” Gilead said.
In 2014, the company had signed a similar deal to sell a low-cost, generic version of Sovaldi, a drug used to treat Hepatitis C but one that cost $1,000 for a daily dose. It had, however, then asked the companies to pay seven per cent of their revenues as royalty fees.
The other terms of licenses signed remain undisclosed.
What will companies gain under the agreement?
The agreements permit the Indian companies to sell the drug in 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,” Gilead said in a press statement. The list includes Afghanistan, Bangladesh, Congo Republic, Egypt, Fiji, Ghana, Kenya, Nepal, Pakistan, India, South Africa and Sri Lanka.
“Under the licensing agreements, the companies have a right to receive a technology transfer of the Gilead manufacturing process for remdesivir to enable them to scale up production more quickly,” the US drug-maker said.
Experimental drug has ‘clear-cut effects’
Remdesivir is increasingly being seen as the drug with the most “clear-cut” positive effects in treating Covid-19.
Last month, Dr. Anthony Fauci, an adviser to US President Donald Trump and a top infectious diseases doctor, said data had shown that “remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery”.
The drug received 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”.