EU Talks to Gilead About Remdesivir Supply

09.07.2020 - After it emerged last week that the US federal government had nailed down the lion’s share of the world’s supply of the antiviral remdesivir, Gilead Sciences’ new drug being touted as a promising treatment for Covid-19, the EU has held talks with the US drugmaker.

EU commissioner Stella Kyriakides spoke with Gilead executives on Jul. 6 in Brussels to hammer out a deal to secure supplies of the drug for 16 EU countries, including Germany, Belgium, the Netherlands, Austria and Denmark, the Bloomberg news agency reported.

The talks followed the European Commission’s conditional approval of the use of remdesivir in severe COVID-19 patients after an accelerated review process, making it the EU’s first authorized therapy to treat the virus. Immediately before, the drug had received the green light from the European Medicines Agency (EMA).

At the meeting with Gilead, Kyriakides was expected to inquire about Gilead’s production capacity and timeline for delivery. While the Commission has not yet made an official comment on the outcome of the talks, it told Bloomberg that capacity and access to remdesivir treatments for EU member states were discussed.

Further discussions “will be pursued at technical level,” the EU governing body added.

In Kyriakides’ words, the EU’s main objective is to ensure that the needs of patients with Covid-19 can be met as quickly as possible in all member states, adding that, “we stand ready to support a coordinated EU procurement procedure to secure swift, broad and fair access.”

Gilead has an obligation to make the drug available to European countries in which volunteers took on the risk of participating in trials without knowing whether the medicine would work, Andrew Hill, a senior research fellow at the University of Liverpool, commented during the discussion of the reported US coup.

Along with remdesivir, which a large clinical trial found shortend recovery time from Covid-19 by about four days in hospitalized patients, a major study by the University of Oxford in the UK showed that dexamethasone, a cheap generic anti-inflammatory, also improved survival in severely ill patients.

Through the end of September, exclusive doses will be distributed to US hospitals for $520 per vial, or $3,120 per treatment course, for patients with private insurance. For patients on government-sponsored insurance, Gilead will charge $390 per vial, or $2,340 per treatment course.

Meanwhile in India, one of the countries hardest hit by the pandemic, generic drugmakers have begun offering the treatment for a much lower price.

Netherlands-domiciled, US-managed generic drugmaker Mylan – one of several companies with production facilities in India and Pakistan who have signed agreements with Gilead – said it plans to launch a generic version of remdesivir in India priced at 4,800 rupees ($64) per mg, about 80% below the price tag on the drug for wealthy nations.

Mylan began producing the drug locally this week at a capacity of up to 1.5 million doses per month.

In July, two Indian drugmakers, Cipla and privately held Hetero Labs, launched generic versions of the drug priced even lower. According to reports, Cipla is pricing its Cipremi-branded treatment at less than 5,000 rupees, while Hetero is pricing its Covifor at 5,400 rupees.

The Drug Controller General of Indian has approved Mylan’s remdesivir version, to be called Desrem in the country, for the treatment of suspected or laboratory-confirmed severe incidences of Covid-19 in adults and children.