EU urged to review remdesivir supply deal after COVID trial results

François Guarascio

BRUSSELS (Reuters) – A 1 billion euro deal with Gilead last week for a six-month supply of COVID-19 medication remdesivir could be renegotiated by the European Union (1,17 billion dollars) after showing disappointing outcomes in a big study, experts said on Friday.

The Solidarity trial performed by the World Health Organisation on Friday, in a hit to one of the few medications used for the care of people with COVID-19, shows that re-devivir had evidently little or little to do with death or hospital time in respiratory disease patients.

The findings of the research were released a week after Gilead 's biggest deal on the provision of a 500,000 course of antiviral medicine, which Gilead claimed to be the norm for rich nations, had been announced by the Executive Commission of the European Union at a price of EUR 2 000 70.

In the light of the outcome of a Solidarity Trial, the Commission "had to provide explanations why it had been hurried in the run-up to the end of the most recent deal with Gilead," said Yannis Natsis, the European Arzneimittel Agency (EMEA, EU medicines regulatory agency) leader of patients' organizations.

On 8 October, the EU declared the signing, on behalf of its 27 Member States and 10 Partner Countries, including the UK, of a supply agreement with this firm.

Since October 6, the WHO has claimed Gilead has been informed of the outcome of the Solidarity trial by quoting the requirements on transparency.

At the end of September Gilead said to Reuters that it had obtained a "extremely written manuscript" from the WHO containing material from the final paper released on Friday.

"Timing is the key"

Since EU countries have warned of remdesivir scarcity in their hospitals, a further increase in COVID-19 infections in Europe, the Commission's decision is taken.

The deal would not compel countries to purchase remedies even though it binds them to the negotiated price.

Poland said two days after the EU deal 80,000 remdesivir vials were requested, which is typically offered in a six-dose regimen.

Gilead did not elaborate, and the company challenged the conclusions, about whether remdesivir rates for wealthier countries could adjust after the WHO verdict.

"We need not only to invest in the production of vaccinations but also the provision of treatment, as time is necessary-because we are in an emergency for public health," said the European Commission Speaker.

He added that the EMA will review the outcomes and the evidence available from other COVID trials "to see whether improvements to the usage of these medications are appropriate."

However, before signing the contract with Gilead, the Spreader had not spoken about whether the EU learned of the effects of Solidarity.

He did not not respond to concerns regarding the prospect of renegotiation in the price negotiated with Gilead.

"Andrew Hill, a senior research fellow in the University of Liverpool, Pharmacology Department, suggests the EU should reconsider rates to be charged for Remdesivir. Why pay 1 billion euros for a medication without impact on survival?"

He claimed that generic drug versions developed in India were sold at € 200 per course.

($1 = EUR 0.8525)

(Francesco Guarascio reports @fraguarascio; John Miller and Anna Koper supplementary reports; Louise Heavens and Gareth Jones edits)