In a blow to the country’s plans to escalate local production of Gilead’s revolutionary lenacapavir HIV prevention shot, South Africa’s biggest pharmaceutical manufacturer, Aspen Pharmacare, has pulled out of government plans for local production of the jab, reports Business Day.
It cites a lack of guaranteed demand as the reason behind the decision, saying it was, 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 LEN, Aspen’s withdrawal is still a setback, as it is one of only a few South African companies with the potential capacity to make the injection.
“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 pharmaceutical companies which invest in lenacapavir production.
Aspen had withdrawn its expression of interest, he added, because it could not risk a repeat of the situation experienced during the coronavirus pandemic. At the time, Aspen clinched a deal with Johnson & Johnson to bottle an Aspen-branded version of its Covid-19 vaccine for Africa but received no orders.
Not local
None of the six voluntary licences Gilead awarded in 2024 – for local production of LEN – 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 organisation had recommended three names to Gilead, he said, but declined to name them. Business Day understands Adcock Ingram is not among them.
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.
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.
Meanwhile, KwaZulu-Natal is hard on the heels of Gauteng in the uptake of anti-HIV jab lenacapavir, with almost 12 000 people, mostly women, having already taken up the twice-yearly treatment, reports The Witness.
The Department of Health said 11 941 people in the province had started on LEN by Monday this week, making KwaZulu-Natal the second-highest province for uptake of the HIV prevention drug after Gauteng.
Nationally, more than 55 123 people had received lenacapavir since the programme launched on 5 June.
The department said 71% of those who have received the injection are female, with pregnant and breastfeeding women making up a large proportion of recipients.
The rollout is taking place through 360 public health facilities in 24 districts across six provinces.
Gauteng recorded the highest number of initiations at 26 357, followed by KZN, North West with 4 479, Western Cape with 4 446, Mpumalanga with 4 294 and Eastern Cape with 3 606.
Healthcare workers and implementing partners are working with provincial health departments to monitor the rollout and investigate any serious adverse events if and where they are reported.
KwaZulu-Natal’s nearly 12 000 initiations place the province at the centre of the national rollout, with the coming months expected to provide a clearer picture of whether the new prevention option can be sustained at scale across the public health system.
The Witness – New HIV jab gains ground in KZN
See more from MedicalBrief archives:
Guaranteed orders vital for anti-HIV jab production – Aspen
Aspen clinches deal to produce new once-a-month HIV tablet
SA firms lose out on lenacapavir production
Aspen SA to halt vaccine output as J&J orders dry up
Another blow to Aspen’s SA plant: WHO has no plans to buy its vaccines