Gilead to start selling remdesivir in coming weeks, expects 'multi-year commercial opportunity'

As Gilead's initial 1.5 million doses of donated remdesivir runs out, the biotech will start charging the drug from around July. (Gilead Sciences)

Gilead Sciences’ initial donation of remdesivir will be exhausted by early summer. The biotech will start charging for the drug in COVID-19 after that, and it might not be just a year or two of revenue flow.

The company will pivot to a commercial plan after the donated supply of 1.5 million doses runs out around June or early July, SVB Leerink analyst Geoffrey Porges wrote in an investor note Monday after talking to Gilead CFO Andrew Dickinson.

Its price? Dickinson quoted the $30,000-per-patient price that one recent cost-effectiveness analysis suggested, and said Gilead will charge a fraction of that, Porges wrote.

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The Institute for Clinical and Economic Review recently found remdesivir would be cost-effective at $28,670 if the analysis used as a benchmark the common $100,000 per incremental quality-adjusted life-year gained. But the U.S. drug cost watchdog argued that $50,000/QALY should be applied to remdesivir during a public health emergency. After that calculation, ICER pegged a reasonable price at $4,460.

For Dickinson, using a tighter threshold for remdesivir seemed unreasonable when the typical standard is $100,00/QALY. The company is running its own cost-savings analysis for hospitals that will be used to inform final pricing, Porges noted.

Dickinson suggested that the cost to manufacture remdesivir is “an order of magnitude greater than” the $10 per 10-day course ICER used in its report, Porges said. Nevertheless, the SVB Leerink analyst expects Gilead would still be able to make money abiding by the $4,460-per-course price. High profit margins might be out of reach at that level, but all eyes are on the drug’s affordability, the analyst noted.

RELATED: Can the price be right? With the world watching, Gilead faces a no-win decision on remdesivir

Although many industry watchers doubt Gilead will report any revenue from remdesivir in 2020, Dickinson said there is a “very real possibility” of sales starting in the second half of the year.

In fact, the drugmaker believes remdesivir holds potential as a “multi-year commercial opportunity,” rather than a short-lived revenue earner for a year or two, Porges noted. In the longer term, Gilead could supply the drug for national stockpiling and is already receiving such requests.

ICER based its evaluation on clinical data from the NIH showing the drug cut recovery time for severe COVID-19 patients by four days, or 31%. That dataset is only the first of many more to come, and “we think there is a real, substantial benefit that will become clearer and clearer,” Dickinson told Porges.

Detailed data from that study will be published in a peer-reviewed journal by the end of the month, and it should help physicians determine the clinical markers of patients who would be most suitable for remdesivir therapy, Diana Brainard, Gilead's senior VP of HIV & Emerging Infections said. 

Another larger study in hospitalized patients with moderate disease will read out in the next four weeks or so, and results from an NIH-run study combining remdesivir with Eli Lilly's JAK immunomodulator Olumiant could come out late summer, she told Porges. 

RELATED: Gilead inks deals with generics makers to supply COVID-19 therapy remdesivir for 127 countries

Gilead has pledged to donate around 1.5 million doses of remdesivir, about 40% of which is going to the U.S. government. But not all of the remaining 60% of supply has been allocated. The biotech is reportedly increasing its U.S. donation to about 940,000 doses by June.  

Outside of the U.S., as demand outpaces supply, Gilead has signed nonexclusive licensing deals with five generic drugmakers operating in India and Pakistan to manufacture remdesivir primarily for low- and lower-middle-income countries.

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