From the newsletter
Pharma manufacturers in Africa can now accelerate entry into generic production of Lenacapavir (LEN) after UK scientists developed a low-cost active pharmaceutical ingredient route. Gilead Sciences, the developer of this long-acting HIV prevention drug, will only manufacture 3 million doses by 2028 against an estimated 20 million demand.
While royalty-free licensing agreements with Gilead Sciences will enable the generic manufacturing and supply of LEN to Africa from 2027, the cost of producing its active pharma ingredient remains a barrier. South Africa is the only African country in talks with Gilead to manufacture LEN locally.
Access to LEN has already sparked debate after Doctors Without Borders revealed that Gilead had refused to sell it directly to them, except through the Global Fund. Gilead responded by increasing the doses from 2 million to 3 million for developing countries by 2028.
More details
The API, developed by scientists at the Manchester Institute of Biotechnology with funding from the Gates Foundation, offers a lower-cost, biocatalytic way to produce a key chiral intermediate in LEN. Considered a breakthrough in HIV prevention, the drug’s complex core has made its API expensive and difficult to manufacture at scale.
Using directed evolution, researchers engineered an aminotransferase enzyme to convert a bulky precursor into the correct chiral form, achieving over 90% yield and high purity. This process replaces multi-step chemical synthesis with a faster, cleaner method, improving scalability and sustainability in global generic supply.
On March 5th, South Africa announced it is in talks with Gilead Sciences to enable local production of LEN, becoming the first African country to signal manufacturing intent. Working with Unitaid, the United States Pharmacopeia, the South African National AIDS Council and partners including the WHO and the Africa CDC, it has issued an expression of interest to identify capable manufacturers
Gilead Sciences, the developer and only manufacturer of LEN, had committed to supplying 2 million doses to low-income countries by 2028 through the Global Fund, against an estimated demand of 20 million doses in Africa alone. On 30 March, Médecins Sans Frontières (Doctors Without Borders) accused Gilead Sciences of refusing to sell LEN directly to them, except through the Global Fund’s allocated share for developing countries.
Following MSF’s demand for response by 13 April, Gilead announced on 14 April, alongside the United States President’s Emergency Plan for AIDS Relief and the Global Fund, an increased commitment to reach up to 3 million people by 2028. This means African pharma manufacturers have an existing demand of over 17 million for generics by 2028.
Our take
Africa has a limited window to build generic manufacturing capacity for LEN before global supply chains become fixed and harder to enter.
With a 17 million demand against 3 million committed supply and generic rollout expected from 2027, early movers can secure market share. Delays risk locking African manufacturers out of both value creation and long-term supply relevance.