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By Francesco Guarascio
BRUSSELS (Reuters) – The European Union is expected to renegotiate a 1 billion euro ($1. 2 billion) contract that it sealed last week with Gilead for six months of re-Adriatic, a COVID-19 drug, after poor effects appeared in a primary trial, experts said Friday.
In a blow to one of the few medicines used to treat others with COVID-19, the World Health Organization solidarity trial showed that remdesivir gave the impression of having little or no effect on mortality or length of hospital stay in patients with respiratory problems. Disease.
The effects of the trial were announced a week after the EU Executive Board announced its largest contract to date with Gilead for the source of 500,000 courses of the antiviral drug worth 2070 euros consistent with treatment, which Gilead said is the norm for rich countries. .
The Commission “must explain the reasons for the haste to conclude the newest contract with Gilead and take the decision to read it carefully to the results of the solidarity trial,” said Yannis Natsis, who again provides patient organisations on the board of the European Medicines Agency. (EMA), the European Medicines Regulator.
The EU announced on 8 October that it had signed the contract with the US company on behalf of its 27 member states and 10 spouse countries, adding Britain.
Gilead had been aware of the effects of Solidarity since 6 October, WHO said, mentioning outreach regulations in the Solidarity trial.
Gilead told Reuters at the end of September that he had won a WHO “strongly written manuscript” containing other data from the final document published on Friday.
‘TIME IS GAS’
The Commission’s resolution came after EU countries warned of a shortage of reintegration into their hospitals amid a new outbreak of COVID-19 infections in Europe.
The contract does not oblige countries to purchase remdesivir, it links them to the agreed price.
Two days after the EU agreement, Poland said it had ordered 80,000 vials of re-division, which are administered in a six-dose scheme.
Gilead said it did not aim to adjust the value of repopulation of countries after the WHO trial, and the company questioned its results.
“Time is running out, we are in a public fitness emergency, we will have to invest not only in the progression of the vaccine but also in access to therapies,” said a spokesman for the European Commission.
He added that the EMA would review the effects of Solidaridad and learn of other studies on COVID remedies “to see if adjustments are needed in the way these drugs are used. “
But the spokesman did not specify whether the EU aware of Solidarity affects before signing the contract with Gilead, nor did he answer questions as to whether the value agreed with Gilead could simply be renegotiating.
“The EU reviews the costs to be paid for Remdesivir. Why pay a billion euros for a drug with no effect on survival?” said Andrew Hill, visiting principal investigator in the Department of Pharmacology at the University of Liverpool.
He claimed that generic versions of the drug manufactured in India were sold for two hundred euros based on price.
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(Information through Francesco Guarascio @fraguarascio; additional information through John Miller and Anna Koper; Edited through Gareth Jones, Louise Heavens and Mark Potter)