By Anthony Deutsch, Alicja Ptak and Francesco Guarascio
AMSTERDAM/WARSAW/BRUSSELS (Reuters) - European countries are facing shortages of COVID-19 drug remdesivir because limited supplies are running out, officials said, with cases surging and the United States having bought up most of drugmaker Gilead's output. <GILD.O>
Gilead Chief Commercial Officer Johanna Mercier said the company expects by next week to be in a position to fulfill orders coming through Europe and by the end of October to be able to meet real-time global demand for remdesivir.
She said the company is working with EU regulators so that remdesivir can be distributed more widely, but without going through the country-by-country economic review process typically required before a pharmaceutical product can be sold in Europe.
In July, the 27 European Union countries and Britain, with a combined population of 500 million, secured doses to treat about 30,000 patients. The United States signed a deal for more than 500,000 courses of treatment, accounting for most of Gilead's output through September.
"Remdesivir has run out," Dutch Health Ministry spokesman Martijn Janssen told Reuters, adding however that new deliveries were expected shortly.
"We want to make sure not only that there is enough supply to go around, but more importantly that everybody has access to it across Europe," Gilead's Mercier said in a telephone interview.
The antiviral drug has been shown to shorten hospital recovery time in severe cases of COVID-19. Remdesivir and the steroid dexamethasone are the only drugs authorised in Europe to treat COVID-19. Both have been given to U.S. President Donald Trump, who is also receiving an experimental antibody cocktail.
Hospitalisations across Europe have been rapidly increasing, although in most countries still far below levels of the spring.
"Due to the increased hospital admissions, the demand for remdesivir is increasing rapidly," the Dutch spokesman said.
Poland's health minister Adam Niedzielski said on Tuesday the drug was in short supply in some hospitals. Its latest shipment from the EU order arrived just last Friday.
Spain, which has Europe's highest infection rate, experienced shortages in late August, its medicine agency said. It has now enough doses to meet needs for the coming weeks, the health ministry said on Tuesday.
Britain, which has joined the EU procurement for remdesivir, has rationed its supply, prioritising COVID-19 patients who need it most, the health ministry said.
Shortages are likely to stir debate about the availability and pricing of COVID-19 drugs. While dexamethasone, a generic medicine, is widely available and cheap, remdesivir is protected by Gilead's patent.
The company has set a $2,340 price per patient for wealthier nations. It says it has also donated treatments for research and to treat hundreds of thousands of patients around the world.
A spokesman for the European Commission, which negotiates medical supply deals on behalf of EU states during the pandemic, was not immediately available for a comment about shortages.
The EU executive is discussing with Gilead a new supply deal, meant to be sealed by late September or the beginning of October "to prevent a delivery gap," a Commission official told health experts from EU governments at a meeting in mid-September, minutes show.
The supplies secured so far by the EU were supposed to cover needs until the end of September. Several officials said new deliveries were expected shortly.
Gilead has expanded its production capacity. Last week it said it was meeting U.S. demand and expected to cover global needs in October, even in the event of future surges of COVID-19.
Available doses in the EU have so far been divided according to the number of cases and hospitalisation rates. But not all EU states face shortages. Germany's health ministry said remdesivir stocks were sufficient for the coming months.
(Reporting by Anthony Deutsch in Amsterdam, Alicja Ptak in Warsaw, Francesco Guarascio in Brussels, Alistair Smout in London, Caroline Copley in Berlin, Emma Pinedo in Madrid, Deena Beasley in Los Angeles; Writing by Francesco Guarascio; Editing by Peter Graff and Richard Pullin)