COVID-19 drugs: Gilead’s remdesivir and Algernon’s alternative

Generics/News | Posted 22/05/2020 post-comment0 Post your comment

Gilead Sciences has signed licensing agreements with five generics manufacturers based in India and Pakistan to increase production of its experimental COVID-19 drug remdesivir.

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Remdesivir is an anti-viral drug developed by Gilead Sciences. The US Food and Drug Administration (FDA) granted emergency use authorization (EUA) for the use of remdesivir to treat COVID-19 in May 2020.

The World Health Organization (WHO) initially described remdesivir as the only drug that ‘may have real efficacy’ and recent data suggests it may shorten the time it takes to recover from COVID-19.

There may therefore be an urgent need to expand supply of the drug. With this in mind, Gilead has signed (non-exclusive) licensing agreements with five generic drug manufacturers – Jubilant Life Sciences Ltd, Cipla Ltd, Hetero Labs Ltd, Mylan NV and Ferozsons Laboratories Ltd – based in India and Pakistan.

Through the agreements, the companies will be able to produce and sell the drug in 127 countries, mainly low- and lower-middle income countries. The companies will also be able to decide their own prices for the drug.

All licenses are to remain royalty-free until WHO declares the public health emergency is over, or until another product (be that a vaccine or a treatment) is approved for COVID-19.

This may be sooner rather than later, as the Canadian firm Algernon Pharmaceuticals has received approval for a clinical trial of their product ifenprodil as a treatment for COVID-19.

Ifenprodil is a neurological drug, originally developed by Sanofi in the 1970s, which Algernon is repurposing as a treatment for respiratory problems including idiopathic fibrosis, acute lung injury and chronic cough.

Animal data has shown that ifenprodil can generate a dramatic reduction in lung fibrosis. A further, independent study showed a significant reduction in mortality in mice infected with H5N1 (a particularly deadly strain of flu) as well as improvements to lung damage. The drug is thought to reduce inflammation in the lung and could possibly reduce the duration and severity of a COVID-19 infection.

The firm has now received approval from South Korea’s Ministry of Food and Drug Safety to enrol patients in a phase II clinical trial to test the drug in COVID-19. The trial is said to include 40 patients with severe pneumonia over a 4-week treatment schedule; and is thought have started on 8 May 2020.

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Source: Algernon Pharmaceuticals, Gilead

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