BioPharma, Policy

US gobbles up nearly all of Gilead Covid-19 drug remdesivir for next 3 months, leaving other nations without

HHS said it had acquired all the supplies of the drug for July and 90% of supplies for August and September. Many developing countries have access to generic versions, but WTO rules could complicate the ability of wealthy nations to import them.

The Trump administration has acquired nearly all the projected supplies of a drug used to treat Covid-19 for the next three months, in a move that reportedly leaves none of it for much of the world.

In a statement Monday, the Department of Health and Human Services said it had acquired more than 500,000 treatment courses of Foster City, California-based Gilead Sciences’ drug remdesivir. This includes 94,200 treatment courses for July, representing 100% of this month’s production, along with 174,900 treatment courses for August and 232,800 treatment courses for September, representing 90% of production for those two months. One treatment course consists of about 6.25 doses.

Pharmaceutical distributor AmerisourceBergen will ship the product and pay no more than the wholesale acquisition price. HHS said it will allocate the drug to state and territorial health departments based on hospital burden, and the departments in turn will allocate it to hospitals, similarly to when Gilead donated 120,000 treatment courses.

“President Trump has struck an amazing deal to ensure Americans have access to the first authorized therapeutic for Covid-19,” HHS 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 move was criticized because it would deprive many patients outside the U.S. of access to the drug. Brian Hicks, an analyst for GlobalData, wrote that because six doses are administered per patient, it means fewer than 100,000 patients will initially be treated with it, and with recent surges in the number of cases, most U.S. patients will not have access to the drug. Meanwhile, patients in other countries will not have access to the drug until October 2020 at the earliest, and it is possible that wealthier, developed countries will purchase all available stocks.

But in an emailed statement, University of East Anglia School of Economics professor Farasat Bokhari wrote that he hoped the generic drugmakers that have received licenses to produce versions of remdesivir would ramp up production.

“Gilead provided free licenses to several generic makers back in May to produce and distribute remdesivir,” Bokhari wrote. “These included Mylan as well as other generic makers in Pakistan and India. The licenses are royalty-free for now, and firms are free to set their own prices and export to another 127 countries. Hopefully these companies will be able to step up and provide supplies throughout the world.”

Bokhari explained that for developed countries, the situation is trickier. There are 37 high-income countries – including those in the European Union, the U.K., Switzerland, Japan, Australia, Canada and the U.S. – that have opted out of the World Trade Organization’s Trade-Related aspects of Intellectual Property Rights, or TRIPS rules, which allow authorities in least-developed countries to issue “compulsory licenses” for patented products in certain situations. They can export supplies of remdesivir made without a license from Gilead under TRIPS rules, but Gilead would still be entitled to a payment. But because of the opt-out from TRIPS by high-income countries, those 37 high-income countries would have to issue their own compulsory license to domestic firms.

Earlier this week, Gilead announced pricing of remdesivir, setting a list price of $3,120 for a full course of treatment for commercial payers in the U.S. and $2,340 for other countries, based on a five-day course of treatment using six vials of drug. Hicks wrote that even U.S. patients covered under private health insurance or certain government programs will struggle to afford treatment at that price, let alone those who lack insurance.

Remdesivir is available in the U.S. under an emergency use authorization from the Food and Drug Administration, based on data from a National Institute of Allergy and Infectious Diseases-sponsored Phase III study showing that among hospitalized patients, it reduced time of hospitalization from a median 15 to 11 days. However, the drug has not shown a statistically significant improvement in survival among Covid-19 patients.

The U.S. accounts for more than one-quarter of the world’s 10.7 million Covid-19 cases, with the country having 2.7 million cases as of Thursday as the epidemic has seen a resurgence due to several states prematurely reopening their economies, at the encouragement of President Trump. The U.S. also accounted for nearly one-quarter of all deaths from Covid-19, with 128,104 of the global total of 517,052.

Photo: Ulrich Perrey, AFP/Pool, Getty Images

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