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Generics green-light for new HIV drug, but Africa peeved

British pharmaceutical company GSK has signed deals with three companies allowing them to make inexpensive generic versions of its long-acting HIV preventive medicine for use in lower-income countries, where most new HIV cases occur, but the absence of African manufacturers has been slammed by the continent.

The injected drug, cabotegravir (CAB-LA), was approved by regulators in the United States in late 2021, and in July last year, the company announced a programme with the United Nations-backed healthcare organisation, the Medicines Patent Pool, aiming to get poor countries access to new HIV therapies far earlier than they did for previous HIV medicines.

Millions died during the HIV/Aids epidemic in Africa in the 1990s and early 2000s, when treatments used widely in wealthy countries were unavailable on the continent.

Pre-exposure prophylaxis (PrEP) is an effective way for at-risk HIV-negative people to reduce the risk of infection. But until recently, it was only available in pill form. GSK’s product is the first non-pill option.

The drugmaker said last year that the new programme could result in the generic form of its injection being available in lower-income countries from 2026.

Its HIV treatment division, ViiV Healthcare, said it had issued voluntary licences – waiving intellectual property rights – to Aurobindo, Cipla and Viatris, which will manufacture the generic versions of the injection.

These will be supplied in 90 countries, subject to regulatory approvals there.

Indian drugmaker Cipla will make the intramuscular injections in India and plans to manufacture in South Africa.

However, Pharmaceuticals Made in SA (Pharmisa) chair Stavros Nicolaou said the dearth of African manufacturers in the deal was at odds with recent policies highlighted in the US President’s Emergency Plan for Aids Relief (Pepfar) and the vaccine alliance Gavi, emphasising the importance of strengthening Africa’s pharmaceutical industry.

He was particularly critical of the MPP's failure to grant licences to African generic drug makers to make cheap versions of the cabotegravir injection, reports Business Day.

“That there is not one African manufacturer among them is puzzling, to say the least,” said Nicolaou. “The MPP has done fantastic work to improve access to HIV, TB and malaria treatments. But it is really difficult for African manufacturers to get licences from them.”

Africa bears the lion’s share of the world’s HIV/Aids burden, and the AU is pushing hard for the continent’s pharmaceutical manufacturers to play a bigger role in making products for combating HIV.

Only four African companies are among the dozens of drug makers awarded sub-licences flowing from the agreements signed by the MPP with 18 patent-holders on products for HIV, TB, malaria, cancer and Covid-19.

Three of these companies are South African: Adcock Ingram, which has licences for nine HIV products; Biotech, with a licence for a Covid-19 antibody test; and CPT Pharma, with one for a Covid-19 treatment. The fourth, Kenya’s Universal Corporation, has a licence to make generic HIV treatments.

Africa’s biggest generic drug manufacturer, SA-based Aspen Pharmacare, has secured voluntary licences directly from patent holders.

MPP spokesperson Sophie Thievenaz said one African company had bid for a licence to make generic cabotegravir, but did not meet the selection criteria. “Aurobindo and Viatris will manufacture in India. Cipla will manufacture in India and has plans to manufacture in SA as well,” she said.

Cabotegravir, administered every two months, was registered by the SA Health Products Regulatory Authority in 2022. While studies have shown it is more effective than daily pills to prevent HIV, whether it will be affordable and readily available in countries hard hit by the virus is debatable.

Thievenaz said the price of generic cabotegravir had yet to be determined, but the MPP expects competition among producers to reduce prices to affordable levels for middle- and low-income countries.

 

Reuters article – GSK licenses companies to make cheap copies of HIV prevention drug (Open access)

 

Business Day PressReader article – Pharma industry pushes for Africa to get licence to make generic HIV injection (Open access)

 

See more from MedicalBrief archives:

 

Start planning cabotegravir injection rollout, say SA experts

 

HIV game-change with SAHPRA approval and vaccine trial breakthrough

 

MSF plea for HIV PrEP drug to be affordable

 

Cost concerns over roll-out of SA's pilot HIV prevention shot

 

 

 

 

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