Developing microbicides

Microbicide trials are taking place all over the world, including countries such as Belgium, Thailand, the U.S, South Africa, Zimbabwe, Nigeria and India. Five microbicide candidates have already been proven safe for daily use and are now in Phase III clinical trials to test their effectiveness. If any one of these five is proven to be effective, it could possibly be available within five years.

These first generation microbicides (those now in Phase III) build on research that took place in the 1990s and are predicted to be about 50 - 60 per cent effective. Promising second and third generation research leads that combine compounds and build on anti-retroviral research mean that the ensuing generations of microbicides could be even more effective. However, these combination drugs are only just entering safety trials and will take seven to ten years before becoming available.

Funding research: a need to engage both public and private sectors

In February 2005, UNAIDS estimated that US$140 million was committed to microbicide research world-wide in 2004. It is estimated that double this amount will be needed each year in order to find enough promising microbicide candidates and to keep the research pipeline moving so that candidate products are advanced to the next stage of testing. Developing a good compound into a viable formulation that is replicable, sustains a good shelf life, and is attractive to users, is estimated to take about US$600 million over the next ten years.

Most of the microbicides research is being carried out with public money . The UK Department for International Development (DFID) is funding the Medical Research Council to develop a microbicide called Pro2000, just entering Phase III clinical testing on a large scale. The National Institutes of Health (NIH) and the U.S. Agency for International Development (USAID) also have large research programmes and are funding collaborating agencies. Other funders include the Ford Foundation, the European Community and countries such as the Netherlands, Norway, Sweden, Denmark and Ireland.

Currently, no major commercial pharmaceutical company has shown interest in investing in microbicide research and development. However, it is important that these companies participate in the search for microbicide candidates as more investment will be needed for continuing development of second and third generation candidates.