The possibility of a pact between Gilead Sciences and a clutch of companies to make the investigational Covid-19 drug remdesivir had been on the boil for several weeks.
But late Tuesday night, Jubilant Life Sciences was first off the blocks to announce a non-exclusive voluntary licensing (VL) agreement with the US-based bio-pharmaceutical Gilead on its antiviral remdesivir.
And if the first one was out, the rest were likely to be close, as well. Soon enough, Gilead revealed the VL deals sealed with companies in India and Pakistan to bolster its production supply for the experimental drug. Largely in line with the word on the street, the companies in the VL pact were Cipla, Hetero, Mylan, Jubilant and Ferozsons Laboratories.
The VL agreements have drawn criticism from health experts, coming even as data on the experimental drug was being assessed. Besides, public health advocates have been calling for sharing information and technology on medicines, vaccines and medical devices, sans patent protection, in the time of the pandemic. In fact, civil society groups had even written to Gilead Chief Executive Daniel O’Day to act in public interest, as an “exclusivity and monopoly-based approach” would, in their words, fail the world in combating the Covid-19 pandemic.
Interestingly, the remdesivir pact comes even as a handful of Bangladesh-based companies received local approvals earlier this month to make generic versions of the drug.
Tech, sans royalties
The VL agreement allows technology transfer from Gilead to the licensed companies who can make and sell their less-expensive versions of the drug in 127 countries, including India. Cipla and Jubilant have also said they would make the active pharmaceutical ingredient as well.
In a departure from the normal practice of taking a royalty payment from licensee companies, in this deal Gilead said, “the licences 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.”
The list of countries were largely “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.
As data from ongoing trials on the drug comes out and if it does indeed make the cut to treat Covid, healthcare groups will be watching its pricing. Gilead had followed a similar policy with its breakthrough hepatitis C drug, sofosbuvir. It attempted to dent opposition to its exorbitant prices by sealing VL deals with a bunch of companies, including Indian generic drugmakers, allowing them to make their versions of the drug and selling them at a lower price and on payment of royalty to Gilead. Despite this, there were instances when patients accessed their requirement of the Hepatitis C drug from India.
Remdesivir has received an Emegency Use Authorisation from the US regulator, allowing use only in the emergency period. The drug has still to get approval from the US Food and Drug Administration.