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South Africa’s biggest pharmaceutical manufacturer, Aspen Pharmacare, has pulled out of government plans for local production of Gilead Sciences’ HIV prevention shot lenacapavir, citing a lack of guaranteed demand, and is instead targeting Merck’s experimental pill, alimatravir.While the South African National Aids Council (Sanac) says it is undeterred in its plans to improve local security of supply by reducing reliance on imported lenacapavir, Aspen’s withdrawal is nevertheless a blow, as it is one of only a handful of South African companies with the potential capacity to make the injection. The manufacturing requirements for sterile products such as injections are more complex than those for making pills.“It is off the table for us because no-one’s going to promise us volumes,” said Aspen CEO Stephen Saad, referring to the government’s reluctance to commit to purchasing from local drugmakers that invest in lenacapavir production. Aspen had withdrawn its expression of interest, he said.Aspen could not risk a repeat of the situation it found itself in during the coronavirus pandemic, said Saad. Aspen clinched a deal with Johnson & Johnson to bottle an Aspen-branded version of its Covid-19 vaccine for Africa but received no orders. South Africa has the world’s biggest HIV burden, with about 8-million people living with the disease. Lenacapavir has been hailed as a potential game-changer in the fight against the HIV pandemic because it provides almost complete protection against infection. None of the six voluntary licences awarded by Gilead in 2024 went to pharmaceutical manufacturers in Sub-Saharan Africa, raising concerns about the lack of production in the region hardest hit by HIV.Gilead subsequently announced that it would open the door to South African drugmakers, with Sanac screening the initial applications. In March, Sanac called for expressions of interest from local firms that would be expected to supply South Africa and the other SADC nations. Aspen warned at the time that local drugmakers would need guaranteed demand to manufacture the shot. Sanac spokesperson Nelson Dlamini said Aspen’s withdrawal of its expression of interest did not compromise the process. “The expression of interest was designed to identify manufacturers with capabilities across the different components of the lenacapavir value chain, and there remain credible manufacturers progressing through the process.“The expression of interest evaluation has been concluded, and the recommended manufacturers are now progressing through the next stage of engagement with Gilead, including further technical assessment,” he said.Sanac had recommended three pharmaceutical manufacturers to Gilead, he said, but declined to name them. Business Day understands that Adcock Ingram is not among them.“Sanac remains focused on the objective of securing a pathway for local manufacturing of lenacapavir for South Africa and the broader Sadc region,” said Dlamini.Saad said Aspen saw Merck’s alimatravir as a “really exciting opportunity”, as a monthly pill was expected to have wider appeal and be easier to provide to patients than injectables. “I’ve seen lots of improvements [in HIV drugs]. We’ve been doing it since 2006. But this is something completely different,” he said.In an unusual move, Merck announced it was awarding voluntary licences before the conclusion of phase 3 clinical trials, the final stage in confirming a medicine’s safety and efficacy. Merck said its aim was to boost generic manufacturing capacity before regulatory approval to avoid the long delays that have characterised access to generic HIV medicines in the past. Phase 2 clinical trials showed alimatravir provided a month of protection against HIV infection within one hour of taking the pill. Two phase 3 trials are under way, with results expected next year.Business Day
