Gilead Licensing Remdesivir Production
Gilead Sciences has tapped five generic drugmakers as partners to further expand supplies of remdesivir, its drug now being trialed in the US as a Covid-19 treatment.
Non-exclusive licensing agreements have been signed with Mylan, Cipla, Ferozsons Laboratories, Hetero Labs and Jubilant Life Sciences, all of which have production facilities in India and Pakistan.
The drugs would be distributed in 127 as yet unnamed countries. Gilead said nearly all are low-income and lower-middle income countries, but the list also is said to include several upper-middle- and high-income countries that face significant obstacles to healthcare access.
With the licensing agreements, the companies gain the right to receive a technology transfer of the Gilead manufacturing process, to enable them to scale up production more quickly. Licensees also can set their own prices for drugs from their own production.
The licenses are royalty-free until the World Health Organization declares an end to Covid-19 as a Public Health Emergency of International Concern or until a pharmaceutical product other than remdesivir or a vaccine is approved to treat or prevent COVID-19, whichever is earlier.
The intravenous drug normally takes months to produce, reports say, and its production also requires sterile drug product manufacturing capabilities. This serves to narrow the number of CDMOs capable of manufacturing the medicine.
Along with hydroxychloroquine, Gilead’s remdesivir has been touted by US president Donald Trump as a treatment for Covid-19. However, unlike the first- mentioned, remdesivir is also regarded by experts such as infectious diseases specialist and presidential advisor Anthony Fauci to have some potential as a treatment for the novel coronavirus.
After much discussion, the US Food and Drug Administration (FDA) gave emergency use authorization for the treatment on May 1, with state health departments being charged with distributing it within the US.
According to the US National Institute of Allergy and Infectious Diseases (NIAID), the agency headed by Fauci, early data for treatment of COVID-19 patients with remdesivir showed a 30% shorter recovery time for hospitalized patients and lower death rates from the virus
Gilead has donated supplies of remdesivir for trials up to now, but the company said these will be exhausted by early summer and it will move to a commercial model. Analysts meanwhile are speculating on what the drug might cost.
While a recent cost-effectiveness analysis suggested a price of $30,000 per patient, Gilead CFO Andrew Dickinson is quoted as saying the price could be a fraction of that.