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Published on 5/08/2020 9:46:53 AM | Source: Reuters

State attorneys general urge U.S. to let other firms make Gilead COVID-19 drug

Posted in Top Stories| #World Market #US #COVID-19

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By Manojna Maddipatla and Michael Erman

A bipartisan group of state attorneys general urged the U.S. government on Tuesday to allow other companies to make Gilead Sciences' COVID-19 treatment, remdesivir, to increase its availability and lower the price of the antiviral drug.

The coalition of more than 30 state attorneys general called on the government to act or allow states to do so, saying in a letter to U.S. health agencies that Gilead "has not established a reasonable price" for remdesivir.

"Gilead should not profit from the pandemic and it should be pushed to do more to help more people," the letter said.

The drugmaker is charging most U.S. patients $3,120 per course, or $520 per vial of remdesivir.

Gilead said in a statement that the AGs were misrepresenting facts about access to remdesivir and that the regulatory actions proposed are unauthorized under these circumstances and would do nothing to speed access.

The medicine is one of only two that have demonstrated an ability to help hospitalized COVID-19 patients in formal clinical trials. It received emergency use authorization (EUA) in the United States and approval in other countries after it shortened hospital stays in a large U.S. trial. [nL4N2CH1FK]

In the letter, the coalition, led by Louisiana Attorney General Jeff Landry and California Attorney General Xavier Becerra, urged RemdesivirFINALLetter202008041.pdf the federal government to exercise its rights under the Bayh-Dole Act and license remdesivir to third-party manufacturers to scale up production.

The letter went to the heads of the U.S. Health and Human Services (HHS) department, the National Institutes of Health, and the Food and Drug Administration.

Gilead and the health agencies did not immediately respond to requests for comment.

The U.S. government, which provided some financial backing for the drug's development, signed a deal with Gilead in June for more than 500,000 courses of the treatment, making up most of the company's output through September.

Gilead agreed to send nearly all of its remdesivir supply to the United States between July and September, according to HHS. The agency and states are managing allocation of the drug to U.S. hospitals over that period.

The government said it would receive around 94,000 treatment courses in July, 175,000 in August, and another 233,000 in September.

Still, the drug has been in scarce supply since the U.S. EUA in May, and hospital staffers and politicians have complained about difficulties getting access to it.

"Shipments are coordinated by the federal (government) and we have a bad disconnect between what they think we need and what we really need," U.S. Senator Marco Rubio of Florida tweeted last month, before announcing further allocation to his hard-hit state.

Over the past four weeks, just under half of the U.S. remdesivir supply has gone to COVID-19 hotspots Florida, Texas, California and Arizona.

Gilead has teamed up with generic drugmakers based in India and Pakistan, including Cipla Ltd and Hetero Labs Ltd, to make and supply remdesivir in 127 developing countries. But only limited production has begun.

Last month, Cipla priced its generic version of remdesivir at $53.34 per 100 milligram vial, roughly one-tenth of the U.S. price.

Gilead shares were down 1.4% at $70.74.

(Reporting by Manojna Maddipatla in Bengaluru and Michael Erman in New York; Editing by Lewis Krauskopf, Bill Berkrot and Simon Cameron-Moore)