Gilead Sciences recently received emergency use authorization from the FDA for its coronavirus treatment candidate remdesivir.
The company now faces a conundrum: either mass-produce the drug to satisfy the rising global demand or license the drug to others, surrendering some of the windfall for which it may have hoped.
Gilead said late Tuesday it is focused on making remdesivir both accessible and affordable to governments and patients worldwide wherever it is authorized by local regulatory agencies.
Gilead outlined several steps it is taking in this regard. The company said it is in discussions with some global chemical and pharmaceutical manufacturing companies regarding potentially awarding voluntary licenses to produce remdesivir for Europe, Asia, and developing countries through at least 2022.
The company is also discussing long-term voluntary licenses with several drugmakers in India and Pakistan to make remdesivir available in developing countries. Talks are also on with the Medical Patent Pool to license remdesivir for developing countries.
Additionally, Gilead said it plans to leverage UNICEF’s experience in providing medicines to low- and middle-income countries during emergency and humanitarian crises.
“Close coordination of remdesivir manufacturing will be critical. This is why Gilead is working to build a consortium of manufacturing partners — to bring efforts together to help maximize global supply,” according to the company.
Gilead also highlighted supply chain risks involving remdesivir, as it requires scarce raw materials, with their own lengthy production time, and specialized manufacturing capabilities.
Gilead Giving Up Profits?
If Gilead is unable to clinch necessary agreements to mass-produce remdesivir, it may have to forgo potential profits, according to a Bloomberg report.
“This is an emergency use drug, so the federal government will certainly want to make this drug available to everyone who needs it,” said IP attorney Steven Roth, according to Bloomberg.
If Gilead succeeds in getting full approval for remdesivir, it has three patents to protect the drug, giving it exclusivity at least until October 2035, the report said.
Additionally, full FDA approval would give Gilead five years of exclusivity, preventing generic sales during that period.
Gilead is therefore treading on thin ice with respect to remdesivir: it’s a question of ramping up or risking a 15-year patent exclusivity that could net the company enough profits to cover the drug’s development costs and more.
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This story originally appeared on Benzinga.
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