Aspen Exits Lenacapavir Local Manufacturing, Backs Merck’s Monthly Oral PrEP

Aspen Pharmacare, South Africa’s largest drug manufacturer, has withdrawn from the country’s expression-of-interest process for lenacapavir local manufacturing. Chief executive Stephen Saad said the company will not invest without a government volume commitment. “It is off the table for us because no-one’s going to promise us volumes,” he said.

Aspen is instead concentrating on Merck’s investigational once-monthly oral PrEP pill, alimatravir (MK-8527). In July 2026 Merck awarded royalty-free voluntary licences, before the Phase 3 readout, to seven generic manufacturers including Aspen, covering 129 low- and middle-income countries. Tablets are operationally simpler than sterile injectables and, in Aspen’s view, will have wider patient and programme appeal.

The South African National AIDS Council (SANAC) said the withdrawal does not derail the process. SANAC spokesperson Nelson Dlamini said the expression of interest was designed to map capabilities across the value chain, and that evaluation is complete. The council has recommended three unnamed South African manufacturers to Gilead for further technical assessment. Adcock Ingram is understood not to be among them. Local production of lenacapavir remains a political and industrial-policy goal for South Africa and the wider SADC region.

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Why Aspen walked away

Saad tied the decision directly to Aspen’s 2021-22 experience with Johnson & Johnson’s Covid-19 vaccine. The company converted sterile capacity in Gqeberha to fill-finish an Aspen-branded African product, Aspenovax, with an announced capacity of hundreds of millions of doses. Multilateral buyers never placed orders. Production lines were later idled and redirected to anaesthetics.

That history now shapes Aspen’s investment rule for long-acting PrEP: a licence plus political support is not enough. Stavros Nicolaou, Aspen’s head of strategic trade, made the same argument in March 2026 when SANAC opened the expression of interest. “There has to be guaranteed off-take and preferential procurement (for local manufacturers),” he said. SANAC itself had already flagged low offtake as a key risk.

Two products, two different bets

Lenacapavir, Gilead’s twice-yearly subcutaneous injection, is approved for PrEP in major markets and is SAHPRA-approved, and South Africa began public rollout from imported stock in June 2026. It is a capsid inhibitor, and the PURPOSE trials showed near-complete protection. South Africa is paying about $60 per person-year through the Global Fund, against a generic introductory target cited at $40 per person-year plus roughly $17 for the oral load.

Alimatravir (MK-8527) is a once-monthly oral tablet, a nucleoside reverse-transcriptase translocation inhibitor. Two Phase 3 trials are running: EXPrESSIVE-10 in adolescent girls and young women in Kenya, South Africa and Uganda, and EXPrESSIVE-11 in men who have sex with men and trans populations, with a readout expected in 2027. Aspen and Merck say protection begins within about an hour, with roughly one week of dosing forgiveness. Oral solid dose is far closer to Aspen’s core generic manufacturing base than sterile injectables.

Saad described alimatravir as “a really exciting opportunity” and “something completely different” after two decades of HIV product work at Aspen. Merck’s decision to license before Phase 3 completion is meant to compress the usual lag between originator approval and generic availability in high-burden markets.

South Africa’s HIV and PrEP context

About 8 million people live with HIV in South Africa, with prevalence around 18% among adults aged 15 to 49, and new infections on the order of 140,000 to 170,000 a year. The country already accounts for roughly one fifth of global oral TDF/FTC PrEP initiations.

President Cyril Ramaphosa launched the public lenacapavir rollout in Secunda on 5 June 2026, starting with 360 facilities in six high-burden provinces. Health minister Aaron Motsoaledi said Gilead had indicated a willing seventh licence if a capable South African firm was identified. The first wave prioritises adolescent girls and young women, sex workers, men who have sex with men, people who inject drugs, transgender people, and pregnant or breastfeeding women.

Early uptake is strong where offered. Health-department data presented at AIDS 2026 showed about 98.5% of HIV-negative people offered a choice between daily oral PrEP and the injection chose the injection. Stock is still originator-constrained: Global Fund support of roughly $29 million was framed as covering on the order of 450,000 to 500,000 person-years at the subsidised price, with a two-year pledge approaching one million doses.

Civil society and HE2RO modelling argue that ending AIDS on a 2030s timetable requires 1.7 to 2.9 million people on lenacapavir each year in South Africa alone. AVAC has estimated about 5 million doses a year globally would be needed for material epidemic impact, while Gilead’s early branded and no-profit pool with PEPFAR and the Global Fund covers 3 million people through 2028.

A timeline of licences and pressure

The sequence matters. In October 2024 Gilead signed six royalty-free voluntary licences (Dr. Reddy’s, Emcure, Eva Pharma, Ferozsons, Hetero and Viatris/Mylan) for generic lenacapavir covering 120 primarily lower- and lower-middle-income countries, with no sub-Saharan African manufacturer in the first cohort. Gilead later said the South African firms it evaluated did not then meet sterile-injectable specifications.

On 5 March 2026 SANAC, with Unitaid and USP partners, opened an expression of interest for South African manufacturers across API and finished-product steps, aiming to inform a seventh voluntary licence for South Africa and SADC. Aspen warned publicly on 16 March 2026 that guaranteed demand was a precondition. On 24 July 2026 Merck announced seven pre-Phase-3 licences for alimatravir, including Aspen, Qcil and UCL, the first time sub-Saharan African manufacturers sat in an initial HIV-prevention licence set, alongside Aurobindo, Cipla, Emcure and Viatris from India. Deputy health minister Joe Phaahla said on 30 July that three South African firms had been shortlisted for lenacapavir. Then, on 4 September 2026, TimesLIVE reported Aspen had withdrawn.

Gilead’s public position is that it supports a South African licensee and prefers end-to-end manufacture, while remaining open to local formulation from imported API as a first step. API capability is scarce in South Africa; fill-finish of a sterile long-acting product is the harder local step.

The economics of lenacapavir local manufacturing

Generic partners have signalled an introductory lenacapavir price near $40 per person-year if volumes are large enough. HE2RO modelling published in PLOS Medicine found that scaling lenacapavir to 1.7 to 2.9 million people a year in South Africa could cut infections by roughly 19% to 31% and bring incidence below 0.1% a decade earlier than baseline, at $2,300 to $3,600 per life-year saved. Those ratios collapse if the commodity price stays at originator or mid-generic levels without volume.

A local sterile plant needs a buyer who can sign for several years: the National Department of Health, SANAC-coordinated SADC pooled procurement, the Global Fund, PEPFAR, or a blended facility. None of those counterparties has, on the public record, offered Aspen a take-or-pay contract. Until one does, capable manufacturers will rationally prefer oral products with a licence already in hand.

What to watch

The names and capabilities of SANAC’s three recommended firms will decide whether a seventh Gilead licence is technically credible without Aspen. Gilead’s licence terms for South Africa matter too: territory, API import permission, quality audit timeline, and whether royalties stay at zero. The 2027/28 budget after the Global Fund tranche decides whether lenacapavir stays a pilot-plus or becomes population PrEP. The alimatravir Phase 3 readout, expected in 2027, either validates Aspen’s oral strategy or intensifies injectable demand. Without a legal preference for locally finished product, even licensed South African firms will lose tenders to Indian generics at $40 per person-year.

The bottom line

Aspen did not reject HIV prevention. It rejected an unfunded sterile manufacturing mandate. Lenacapavir remains the most effective prevention tool South Africa can put in clinics in 2026-27, but early supply is imported, priced off Global Fund terms, and far below the volumes modelling says are needed. Merck’s monthly pill is a 2027-or-later option with a more manufacturer-friendly licence design and an African producer already signed.

The tension sits between those facts: South Africa wants regional production of the injection, Gilead is open in principle to a seventh licence, and the largest local manufacturer will not build for a market that will not contract. Until offtake is written down, by Pretoria, SADC, or the global funds, lenacapavir local manufacturing will proceed, if at all, with smaller firms and a longer clock.

Source: TimesLIVE / Business Day, “Exclusive: Aspen opts not to make HIV prevention jab lenacapavir” (4 September 2026).