Gilead expects to receive emergency approval for its potential drug remdesivir Covid-19 soon, as it expands production to be able to do 140,000 10-day courses by the end of May – and 1m by the end 2020.
Daniel O’Day, CEO of Gilead, said there was a “sense of urgency” in the biotechnology group’s discussions with the US Food and Drug Administration, with increased intensity in recent 48 hours, because it became clear that a trial led by the United States was positive. results for the drug.
“I think the FDA understands the importance of reacting quickly to this,” he said.
President Donald Trump has said he would like the regulator to act as quickly as possible. Emergency clearance would be the first step before Gilead requests full approval, said O’Day.
The California-based company said Thursday it had spent $ 50 million on research and development on remdesivir in the first quarter, increasing its overall R&D investment to $ 1.1 billion. He said spending on drugs could become a big investment this year.
Gilead made the first 1.5 m bottles available free of charge, either for trial patients or for compassionate use. But when pressed by analysts, Mr. O’Day would not commit to a price or profit margin.
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“There has never been a time like this in the history of the planet we have been alive in,” he said. “We need to be very thoughtful about how we can make sure that we provide access to medicines for patients around the world. And do this sustainably for the company, for you as shareholders. Rest assured, we understand our responsibility. “
Gilead is investigating the possibility of authorizing other manufacturers to also produce remdesivir. But O’Day warned that care should be taken to strengthen the ingredient supply chain, as Gilead is trying to do with a consortium of pharmaceutical chemical manufacturers.
“Given the scarcity of some of the starting materials, we want to make sure that we don’t do anything to impact our supply chain. It’s the quickest way to get the product to patients, “he said.
Gilead released a study on Wednesday showing that some patients may as well be successful on a five-day course, so supplies can cover more patients than originally planned on a 10-day course.
In the longer term, Gilead is also investigating whether remdesivir could be developed in different formats such as an inhaler. It is currently administered as an intravenous solution.
Gilead has not given a forecast for the coming year. Stocks fell 1.9% to $ 82.39 in after-hours trading in New York.
Gilead’s shares have soared so far this year on investors’ hopes that remdesivir could help Covid-19 patients. On Wednesday, there were positive signs from a randomized trial by the National Institutes of Health in the United States showing that patients taking the drug recovered 31% faster than those on placebo. The news supported the stock by almost 6%.
In the first quarter, Gilead exceeded expectations on profits and revenues. It reported adjusted earnings per share of $ 1.68, higher than analysts’ average estimate of $ 1.57, and net earnings of $ 1.6 billion, down 21% year-on-year. the other.
Sales were supported by storage, particularly of HIV drugs, which Gilead said added about $ 200 million in the quarter. Total revenue was $ 5.5 billion, slightly more than expected and an increase of 5% year-over-year.
O’Day said he believed the pharmaceutical industry’s role in the crisis would help boost its reputation – although he said worries about drug prices would continue. He said the public would see “the ability of the industry to resolve a human crisis like this due to decades of risky investments.”