EU Approves Gilead’s Remdesivir For COVID-19 In Record Time
Despite The Controversy, Blockbuster Status Is Predicted
Executive Summary
The EU has granted conditional marketing approval to Gilead’s drug, which has the brand name Veklury. It will cost about €2,000 per treatment.
The European Commission's decision to issue a conditional marketing authorization for Gilead Sciences Inc.'s COVID-19 therapy, Viklury (remdesivir), comes just eight days after the European Medicines Agency's drug evaluation committee, the CHMP, delivered a positive opinion on the product's approval. In normal circumstances the commission has 67 days in which to grant an MA after a CHMP recommendation. (Also see "Remdesivir’s EU Approval For COVID-19 Due Within Days" - Pink Sheet, 25 Jun, 2020.)
The decision also comes just two days after Gilead announced that the US government had bought up nearly all of its current stocks of the antiviral therapy, amounting to three months’ supply. This news caused consternation among many observers in Europe, who fear that the US may take a similar approach once the first COVID-19 vaccines become available.
Gilead, however, will not want to keep its customers in Europe waiting for too long. The company is hoping that the donated stock it has already supplied to the region will last until it can ramp up its manufacturing output over the course of 2020 and 2021. This could prove to be the case, as SARS-CoV-2 infection rates are generally low or declining across Europe, while the US has seen a rapid rise in new infections in the past week.
While the US bulk purchase represents around 500,000 doses, Gilead aims to increase its output to 3 million doses this year, rising to 10 million next year.
A Blockbuster In The Making?
Veklury is the first new therapy approved to treat COVID-19 in the EU. The approval follows an emergency use authorization (EUA) in the US in May and a similar decision in Japan.
A conditional marketing authorization in Europe is initially valid for one year, but can be extended or converted into a standard marketing approval once further confirmatory data are submitted and reviewed.
The drug is indicated for the treatment of COVID-19 in adults and adolescents (aged 12 years and older and weighing at least 40kg), with pneumonia requiring supplemental oxygen.
Gilead has delayed the announcement on its commercial pricing for some time, but finally announced it on 29 June, setting a developed-nations price for a five-day treatment course at $2,340 (€2,080) per patient. The company has set a higher price of $3,120 for private US insurers.
Gilead has arranged licensing deals with numerous generic manufacturers to supply developing nations, allowing these companies to negotiate their own prices with governments. (Also see "Remdesivir Compulsory Licensing Is A Dead End For Europe" - Generics Bulletin, 2 Jul, 2020.) Early indications are that these prices will be $60-70 per vial.
Analyst interpretations of what this mean for the commercial potential of the drug vary greatly. The consensus sales figure for 2020 is around $820m, rising to $1.8bn in 2021. However SVB Leerink’s Geoffrey Porges is much more bullish about the trajectory of the drug, forecasting $1.9bn in revenues from this year alone, and rising as high as $6.6bn next year.
Porges said. “We believe the disclosed [remdesivir] pricing is reasonable and should provide significant value to the Gilead shareholders and still deflect much of the criticism the company might face in this emergency.”
This view is not so common outside the investment sector, with the decision on pricing and the lack of supplies in Europe drawing sharp criticism.
"The trial that gave the result that allowed remdesivir to sell their drug wasn't just done in the US. There were patients participating through other European countries, in the UK as well, and internationally, Mexico and other places," Oxford University's Professor Peter Horby, principal investigator of the RECOVERY trial, told BBC Radio 4.
He said this could have implications for future vaccine supplies, and called for "a much stronger framework if we are going to develop these things and they're going to be used for national emergencies".
It remains unclear just how great the demand for remdesivir will be across the globe. So far trial data has shown that on average the drug can reduce the length of a hospital stay from 15 days to 11 days compared with placebo in severely ill patients, but it has not shown any impact on mortality.
This is in contrast to results from the RECOVERY trial, which show that the generic corticosteroid dexamethasone significantly cut mortality in patients receiving oxygen and mechanical ventilation.
Gilead is conducting further research on remdesivir, including its use earlier in the course of the disease, in outpatient settings, in an inhaled formulation, and in combination with other treatments, including Roche’s Actemra (tocilizumab).