The Donald Trump administration has secured nearly the entire world stock of antiviral drug remdesivir from US-based Gilead Sciences for the next three months, leaving hardly any stock of the key Covid-19 drug for the rest of the world.
As a result of an agreement with the drug maker announced earlier this week, the US Department of Health and Human Services (HHS) has secured more than 500,000 treatment courses of the drug for American hospitals through September.
This represents 100 per cent of Gilead’s projected production for July (94,200 treatment courses), 90 per cent of production in August (174,900 treatment courses), and 90 per cent of production in September (232,800 treatment courses), in addition to an allocation for clinical trials.
A treatment course of remdesivir is, on average, 6.25 vials, the US Health and Human Services said.
The agreement allows hospitals in the US to purchase the drug in amounts allocated by HHS and state health departments.
Hospitals in the US will receive the product shipped by AmerisourceBergen and will pay no more than Gilead’s Wholesale Acquisition Price (WAC), which amounts to approximately $3,200 per treatment course.
“President Trump has struck an amazing deal to ensure Americans have access to the first authorised therapeutic for Covid-19,” US Health and Human Services Secretary Alex Azar said in a statement.
“To the extent possible, we want to ensure that any American patient who needs remdesivir can get it. The Trump Administration is doing everything in our power to learn more about life-saving therapeutics for COVID-19 and secure access to these options for the American people.”
Remdesivir is considered a key drug in the fight against Covid-19 as a randomised clinical trial conducted with the drug on 1,063 patients over 60 centres across US, Europe and Asia demonstrated a faster time to clinical recovery in hospitalised patients as compared to placebo.
To expand supply of remdesivir, Gilead earlier announced non-exclusive voluntary licensing agreements with generic pharmaceutical manufacturers based in India, Egypt and Pakistan
The agreements allow the companies — Cipla Ltd.; Dr. Reddy’s Laboratories Ltd.; Eva Pharma; Ferozsons Laboratories; Hetero Labs Ltd.; Jubilant Lifesciences; Mylan; Syngene, a Biocon company; and Zydus Cadila Healthcare Ltd. — to manufacture remdesivir for distribution in 127 countries.
The 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.
The regulatory approval status of remdesivir varies by country, and the distribution of remdesivir within each country is subject to local laws and regulations.
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 licensees also set their own prices for the generic product they produce.
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.