The World Health Organization has demanded the prices of a Gilead Sciences drug to treat black fungal infections by cutting back and increasing supplies amid a sharp rise in cases among Covid-19 patients in India and Nepal.
The California-based pharmacist produces AmBisome, a lipid-based amphotericin, which is used to treat the disease, also known as mucormycosis. Cases of black fungus, which begin in the nose and spread rapidly to the eyes and brain, are usually rare, but are common during the coronavirus crisis in South Asia. Many patients need surgery to remove dead tissue killed by the infection and at least 50 percent of people die.
Mariângela Simão, WHO’s assistant director-general for access to medicines, told the Financial Times that Gilead must adapt an existing agreement to provide AmBisome at lower prices for poorer nations so that it includes the treatment of cases of black fungus linked to coronavirus.
“An immediate strategy to expand the supply and improve the accessibility of lipid-based amphotericin is to integrate it into the existing Covid-19 response and for Gilead to expand its existing provision of lower prices to Covid patients,” he said. said Simon.
Between 150 and 300 vials of the drug are needed to treat a single patient, and a vial can cost up to $ 69 in India, according to an open letter sent to Gilead in June by Doctors Without Borders and experts from Yale and Georgetown universities in the United States. US. Gilead agreed to a more favorable price of $ 16.25 per bottle in 116 low- and middle-income countries by the end of 2018, but so far had not extended this price to patients suffering from black fungus due to complications from Covid-19, the letter said. MSF has reported prices up to $ 200 for vials in countries technically covered by the access agreement.
Gilead told FT that in India the price of the drug and the terms of supply are being negotiated by the American company Viatris, also known before as Mylan, which holds the marketing authorization for AmBisome in the country.
Viatris, in response to questions, said the drug was “complex” and “involves an exceptionally long cycle to produce.”
“This is even more critical when there is a sudden increase in demand, as in this case,” he said, adding that he was “continuously meeting” volume requests from the Indian government. “We will continue to partner with all stakeholders and the Government of India for ongoing efforts to accelerate access to critical medicines for patients with Covid-19 in India,” Viatris said.
In their June letter to Gilead, MSF and its co-authors accused the company of hiding along the technology that supports drug manufacturing as a “trade secret,” preventing the creation of a “stable global supply” that generic competition is has been significantly delayed ».
“It simply came to our notice then [AmBisome] it is one of the few drugs where Indian companies have not broken Gilead’s monopoly, ”Leena Menghaney, the regional head for MSF’s access campaign to South Asia, told FT.
The companies responded to the open letter saying they were doing what they could to deal with the situation. The AmBisome supply problem was exacerbated by the diversion of some manufacturing capacity to produce another Gilead Covid-19 drug, remdesivir.
Gilead, which had sales of AmBisome worth $ 436 million last year, has faced early criticism from politicians and doctors who have accused it of pricing other drugs too high, including remdesivir , which can cost up to $ 3,210 for a five-day course.
More information from Kiran Stacey