Aspen Pharmacare has announced that it will no longer pursue the manufacturing of lenacapavir, a long-acting HIV prevention injection, and instead focus on producing alimatravir, an experimental HIV prevention pill. This decision comes as the company seeks to capitalize on the potential of alimatravir, which is being evaluated in two ongoing clinical trials as a potential once-monthly HIV prevention pill. The shift in focus is significant, given the promise of lenacapavir in preventing HIV infections.
In South Africa, the rollout and uptake of HIV prevention medicines have been slower than expected. Currently, only around 350,000 people are using HIV prevention tablets, while approximately 60,000 people have started taking the twice-yearly lenacapavir injections. The limited scale of the rollout is due to both supply and affordability challenges. The health department has been working to address these challenges, including through a Global Fund procurement arrangement that has allowed donors to pay an additional confidential top-up amount to Gilead Sciences.
The cost of HIV prevention medicines has been a significant barrier to their adoption. HIV prevention tablets cost the health department around $40 per person per year, while the lenacapavir injection costs $60 per person per year through the Global Fund procurement arrangement. In contrast, research presented at the 2026 International Aids Society Conference suggests that alimatravir could be profitably produced for a price tag as low as $3 per person per year. This significant reduction in cost could make HIV prevention more accessible to those who need it.
Alimatravir is already influencing the market for HIV prevention products, despite the absence of phase III data. Aspen Pharmacare's decision to focus on alimatravir is a significant example of this. The company, along with six others, has been licensed to produce generic versions of alimatravir by MSD. This unusually early licensing is expected to contribute to the affordability of the product, if it is shown to be effective in preventing HIV.
The development of alimatravir is being closely watched by health economists and HIV prevention experts. Dr. Samuel Cross of Christchurch Hospital told conference delegates that the methodology used to calculate the $3 per person per year price is the same methodology that has previously been used to predict the manufacturing cost of several medicines. However, some caution is warranted, given that alimatravir's safety and efficacy have not yet been definitively proven.
The final verdict on alimatravir will come from two ongoing Phase 3 clinical trials, called EXPrESSIVE-10 and EXPrESSIVE-11, both expected to report in 2027. Regulators typically approve medicines only after positive findings from such phase 3 trials. In the meantime, the potential for alimatravir to become a highly affordable option for HIV prevention is generating significant interest and attention.
Aspen Pharmacare's decision to focus on alimatravir reflects the company's efforts to adapt to changing market conditions and priorities. According to Stavros Nicolaou, senior executive for strategic trade at Aspen Pharmacare, the company's decision was influenced by the South African government's current pharmaceutical procurement policies and practices. As the HIV prevention landscape continues to evolve, companies like Aspen Pharmacare are likely to play a critical role in shaping the availability and accessibility of new prevention technologies.
Key points
- Aspen Pharmacare shifts focus from lenacapavir to alimatravir for HIV prevention.
- Alimatravir could be produced for $3 per person per year, significantly reducing the cost of HIV prevention.
- The safety and efficacy of alimatravir have not yet been definitively proven, with phase III trials expected to report in 2027.
