WHO calls for lowers prices on Gilead drug for Covid-linked black fungus

The World Health Organization has called for prices of a Gilead Sciences drug to treat black fungus infections to be cut and supplies boosted amid a sharp rise in cases among Covid-19 patients in India and Nepal.

The California-based drugmaker produces AmBisome, a lipid-based amphotericin, which is used to treat the condition, also known as mucormycosis. Cases of black fungus, which starts in the nose and quickly spreads to the eyes and brain, are normally rare, but have soared during the coronavirus crisis in south Asia. Many patients require surgery to scrape out the dead tissue killed by the infection and at least 50 per cent of people die.

Mariângela Simão, the WHO’s assistant director-general for access to medicines, told the Financial Times that Gilead should adjust an existing agreement to supply AmBisome at lower prices to poorer nations so that it includes the treatment of black fungus cases linked to coronavirus.

“An immediate strategy for broadening supply and improving affordability of lipid-based amphotericin is to integrate it into the existing Covid-19 response and for Gilead to extend their existing lower pricing arrangement to Covid patients,” Simão said.

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 Médecins Sans Frontières and experts at Yale and Georgetown universities in the US. Gilead agreed more favourable pricing of $16.25 per vial in 116 lower and middle-income countries in late 2018, but had so far not extended this price to patients suffering from black fungus due to complications from Covid-19, the letter said. MSF has reported prices of up to $200 per vial in countries technically covered by the access agreement.

Gilead told the FT that in India the price of the drug and the terms of supply are negotiated by the US company Viatris, previously also known as Mylan, which holds the marketing authorisation for AmBisome in the country.

Viatris, in response to questions, said the drug was “complex” and “involves an exceptionally long cycle time to produce”.

“This is even more critical when there is a sudden surge in demand, as in this case,” it said, adding it was “continually meeting” volume requests from the Indian government. “We will continue to partner with all stakeholders and the government of India for the ongoing efforts to accelerate access to critical medicines for patients with Covid-19 in India,” Viatris said.

In the June letter to Gilead, MSF and its co-authors accused the company of long hiding the technology that underpins the manufacture of the drug as a “trade secret”, preventing the creation of a stable global supply “as generic competition has been significantly delayed”.

“Unfortunately [AmBisome] is one of the few drugs where the Indian companies have not broken Gilead’s monopoly,” Leena Menghaney, the regional head for MSF’s access campaign in south Asia, told the FT.

The companies have responded to the open letter saying they were doing what they could to address the situation. The AmBisome supply problem has been exacerbated by the diversion of some manufacturing capacity to produce another Gilead Covid-19 drug, remdesivir.

Gilead, which had AmBisome sales worth $436m last year, has faced criticism before 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.

Additional reporting by Kiran Stacey

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