There is much discussion on how new drugs can be developed for use in developing countries at a price that makes them accessible to those who need them most. The development of a new antimalarial, chlorproguanil/dapsone (Lapdap), provides an example of a way this can be achieved. The idea of combining chlorproguanil with dapsone came from studies done in east Africa in the 1980s. These studies showed, both in vivo and in vitro, that chlorproguanil/dapsone had advantages over sulphadoxine/pyrimethamine. A public-private partnership was established subsequently to manage a development programme of a fixed ratio tablet of this drug combination. The partnership comprised GlaxoSmithKline (formerly SmithKline Beecham), the World Health Organization (WHO), and the UK's Department for International Development (DFID). All clinical, toxicological, and pharmaceutical chemistry studies are complete and the findings have been submitted for regulatory approval. The question now is how Lapdap might be used safely and appropriately if it receives regulatory approval. A public-health group has been formed by WHO (with funding from DFID and the Gates Foundation) to research into this issue. The Lapdap development team completed its objective of submitting Lapdap for drug registration within a period of 5 years and at a low cost. Experience with the development of Lapdap may provide a model for the introduction of other new drugs developed primarily for use in developing countries.
