Local drugmakers will need guaranteed demand to produce the HIV prevention shot lenacapavir, South Africa’s largest generic manufacturer, Aspen Pharmacare, has warned.
South Africa is home to 17% of the world’s HIV population and has one of sub-Saharan Africa’s biggest pharmaceutical manufacturing industries, yet none of the six voluntary licences awarded by Gilead Sciences — the patent holder — to generic drug makers in 2024 went to a South African firm.
At the time, no local manufacturer could meet Gilead’s condition that licensees manufacture the active pharmaceutical ingredient (API) used in the medicine.
Lenacapavir is taken as a twice-yearly shot, along with an initial dose of tablets, and has been shown to provide almost complete protection against HIV. It is seen as one of the most promising tools to change the trajectory of the HIV epidemic, particularly in high-burden countries like South Africa.
While South Africa has been provided with support from the Global Fund to Fight Aids, TB and Malaria to purchase an initial supply of lenacapavir, it has been excluded from US plans to provide the drug to countries hard-hit by HIV, highlighting its vulnerability to shifts in donor funding.
The government is now in discussion with Gilead to identify local pharmaceutical manufacturers capable of producing lenacapavir under voluntary licence in South Africa.
The expectation is that companies that do not have the capacity to manufacture the API at the outset will be able to import it, according to the South African National Aids Council (Sanac), which earlier this month called for expressions of interest from pharmaceutical manufacturers.
Aspen’s head of strategic trade, Stavros Nicolaou, said companies needed an assurance that there would be customers for their products if they were to invest in making lenacapavir.
“There has to be guaranteed off-take and preferential procurement (for local manufacturers),” he said in an interview with Business Day.
Sasfin senior equity analyst Alec Abraham said only a handful of South African pharmaceutical manufacturers currently had the sterile manufacturing capability required to make injectable medicines.
Aspen was one of the few companies that had such capacity at scale, he said, referring to its sterile manufacturing plant in Gqeberha. Adcock Ingram, which also has sterile manufacturing capacity, did not respond to Business Day’s request for comment.
Aspen’s appeal for guaranteed off-take stems in part from its experience during the coronavirus pandemic, when it invested in manufacturing Johnson & Johnson’s Covid-19 vaccine for Africa but received no orders.
There has to be guaranteed off-take and preferential procurement (for local manufacturers)
It has also repeatedly raised concerns about the extent of government support for the local pharmaceutical manufacturing industry, as the health department has frequently awarded contracts to firms that import cheaper products.
In 2023 state-backed vaccine manufacturer Biovac lost out on a crucial contract for pneumonia shots after the health department opted for cheaper jabs imported from India.
More recently, well-established local pharmaceutical manufacturers, including Adcock Ingram, Cipla Medpro and Sisonke, were excluded from a three-year Aids drug tender.
Low off-take had been identified as a key risk to the success of the initiative by the ad hoc committee on lenacapavir licensing, said Sanac CEO Thembisile Xulu. The committee is an intergovernmental body chaired by Sanac and supported by the Unitaid-established MedSuRe Africa regional manufacturing programme.
“There are ongoing engagements under way to work with relevant stakeholders through a co-ordinated approach to better understand existing and projected demand volumes. This work is intended to ensure any future local manufacturing participation is aligned with programme needs, market certainty and sustainability considerations,” she said.
The initiative sought to phase in capability and capacity across the value chain, she said.
Nicolaou said there was limited API production capacity in South Africa, and pharmaceutical manufacturers would likely seek to begin with product formulation.
Would you like to comment on this article?
Sign up (it's quick and free) or sign in now.
Please read our Comment Policy before commenting.