By Deena Beasley
(Reuters) – Gilead Sciences Inc, maker of the closely-watched experimental coronavirus drug remdesivir, on Thursday said it will work with international partners to expand production of the potential COVID-19 treatment.
The company said it still expects to have more than one million remdesivir treatment courses manufactured by December, “with plans to be able to produce several million treatment courses in 2021.”
By the end of next month, Gilead said it expects to have manufactured enough of the drug to treat more than 140,000 patients, and it plans to donate that supply to hospitals.
The company said it has been in constant dialogue with the U.S. Food and Drug Administration about making remdesivir, which is given to hospitalized patients by intravenous infusion, available to patients as quickly as possible.
“There is a big sense of urgency here,” Gilead Chief Executive Daniel O’Day said during a conference call with analysts.
He said the FDA could issue an emergency use authorization for remdesivir, but Gilead is also seeking standard regulatory approval of the drug.
O’Day declined to answer questions about whether Gilead plans to eventually profit from the COVID-19 treatment rather than just donate the medicine. The company has made billions of dollars on its drugs for HIV and hepatitis C.
“There has been no other time like this in the history of the planet,” he said.
First quarter sales of Gilead’s HIV drugs rose to $4.1 billion from $3.6 billion a year earlier.
Gilead also reported flat first-quarter earnings and its shares fell 2% in extended trading. The U.S. National Institutes of Health on Wednesday said preliminary results from its trial of remdesivir showed that COVID-19 patients given the drug recovered 31% faster than those given a placebo.
In that 1,063-patient trial, patients who received the Gilead drug recovered in 11 days compared with 15 days for those who received a placebo.
While the data will need more analysis to know just how well the drug might work and for which patients with COVID-19, it was hailed by U.S. health officials as highly significant since it clearly had an effect on the disease for which there are currently no approved treatments or vaccines.
Data from a trial run by Gilead, also unveiled on Wednesday, showed similar clinical improvements in patients with severe symptoms of COVID-19, regardless of whether they received five or ten days of treatment.
If the drug works just as well in half the time, there would be twice as much available for patients and the cost of therapy would be less.
More detailed results of the U.S. study are expected next month. There are several other studies also looking at remdesivir for the coronavirus.
On Thursday, The European Medicines Agency said it has started a ‘rolling review’ of data on the use of Gilead’s antiviral drug for the treatment of COVID-19.
A rolling review allows the agency to speed its assessment of promising experimental medicines during a public health emergency.
Gilead said its first-quarter profit was largely flat from a year ago as a 5% increase in sales was offset by higher costs, including spending related to development of remdesivir.
Gilead posted adjusted earnings of $1.68 a share on revenue of $5.55 billion in the quarter. Wall Street analysts, on average, forecast a profit of $1.57 on revenue of $5.45 billion, according to Refinitiv IBES.
(Reporting By Deena Beasley; Editing by Bill Berkrot)