The country’s largest generic manufacturer, Aspen Pharmacare, has warned that local drugmakers will need guaranteed demand to produce Gilead’s twice-year HIV prevention shot lenacapavir, reports Business Day.
Aspen’s appeal for guaranteed orders stems partly from its bitter experience during the pandemic, when it invested in manufacturing Johnson & Johnson’s Covid-19 vaccine for Africa but received no orders.
The government is currently in discussions with Gilead Sciences to identify local manufacturers who can produce lenacapavir under voluntary licence here – none of the six licences awarded by the patent holder to generic drugmakers in 2024 went to a South African firm.
The expectation is that companies that do not have the capacity to manufacture the API at the outset will be able to import it, said the South African National Aids Council (SANAC), which this month called for expressions of interest from pharmaceutical manufacturers.
However, 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 told Business Day.
Sasfin senior equity analyst Alec Abraham said only a handful of South African pharmaceutical manufacturers had the sterile manufacturing capability required to make injectable medicines.
Aspen was one of the few companies that had such capacity at scale, he added, referring to its sterile manufacturing plant in Gqeberha.
Aspen has 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.
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 to work with relevant stakeholders through a co-ordinated approach to better understand existing and projected demand volumes… to ensure any future local manufacturing participation is aligned with programme needs, market certainty and sustainability considerations,” she said.
Nicolaou said there was limited API production capacity in South Africa, and pharmaceutical manufacturers would probably want to begin with product formulation.
See more from MedicalBrief archives:
SA lines up plans to make its own six-monthly anti-HIV jab
SA firms lose out on lenacapavir production