Aspen in South Africa drops lenacapavir licence in favour of alimatavir — Daily Maverick
South African company Aspen Pharmacare has stopped seeking a licence for local production of generic lenacapavir for HIV prevention. Instead, the manufacturer plans to develop capacity to produce alimatavir, an experimental pill that could potentially be taken once a month. Daily Maverick reports.
Reasons for Aspen's decision
Aspen's senior executive for strategic trade, Stavros Nicolaou, said that South Africa's current public procurement rules for medicines do not provide the company with sufficient guarantees of a return on investment in lenacapavir production. Among the factors behind the decision, he cited the absence of guaranteed purchases by the health department, the lack of a preferential policy for local manufacturers, and the emergence of competing drugs, including alimatavir.
Nicolaou also noted that establishing tablet production is cheaper than setting up manufacturing for injectable drugs. According to him, the early licensing of alimatavir for generic manufacturers makes this product more attractive to Aspen. The company has not yet named a possible price for the drug.
Alimatavir is still undergoing trials
Alimatavir does not yet have final confirmed data on safety and efficacy for HIV prevention. The results of two phase III clinical trials — EXPrESSIVE-10 and EXPrESSIVE-11 — expected in 2027, are to be decisive. Regulators usually approve medicines after positive results from trials of this phase.
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At the International AIDS Society conference in 2026, health economists presented an estimate that alimatavir could be profitably manufactured for about $3 per person per year. This is not an announced market price: generic manufacturers have not yet said how much the drug will cost.
Lenacapavir supply
Lenacapavir provides protection against HIV for about six months after an injection. In June, South Africa's health department began rolling out the drug at about 10% of public healthcare facilities, but demand currently significantly exceeds available volumes. The department pays $60 per person per year through the Global Fund procurement mechanism, while donors pay Gilead Sciences an additional confidential amount.
Gilead has licensed six companies to produce generic lenacapavir. Agreements with India's Hetero and Dr Reddy's provide for a generic price of $40 per person per year. Hetero has already submitted the drug for registration in South Africa, with approval expected in early 2027.
