Neglected Disease Products in Clinical Development as of July 2009.

Sources: BIO Ventures for Global-R&D Landscape, <http://www.bvgh.org/resources/landscape/default.asp>; Cowen and Co. Pharmaceuticals Industry Overview, May 2009; PhRMA Medicines in Development Factsheets for HIV/AIDS, infectious disease, and biotechnology; International Federation of Pharmaceutical Manufacturers and Associations, “Pharmaceutical Industry R&D for Diseases of the Developing World-2009”, <http://www.ifpma.org/documents/NR12400/Status_RnD_for_DDW_07Jul09.pdf>; ClinicalTrials.gov; Moran, et al. (2007) “The Malaria Product Pipeline: Planning for the Future.” The George Institute for International Health, <http://www.thegeorgeinstitute.org/research/health-policy/current-projects/the-malaria-product-pipeline-planning-for-the-future.cfm>; websites, press releases, and reports from various PDPs and NGOs including the Meningitis Vaccine Project, PATH (including Malaria Vaccine Initative), Medicines for Malaria Venture, Alliance for Microbicide Development, Drugs for Neglected Diseases Initiative, International AIDS Vaccine Initiative, AIDS Vaccine Advocacy Coalition, Global Alliance for TB Drug Development Note to table 4: Table 4 presents a snapshot of active drugs, vaccines, and microbicides in clinical development for neglected diseases as of July 2009. Using the inclusion criteria outlined in Moran et al., the majority of products were located using commercial and public reports from trade associations (PhRMA, IFPMA), commercial entities (Cowen and Co.), various product development partnerships (PDPs) and NGOs (BioVentures for Global Health), and government agencies such as the NIH and US Department of Defense. Products were only included when their status could be verified through secondary sources, which included clinical trial records from ClinicalTrials.gov, information posted on company websites, and website information from the sources listed in the table. The table should not be considered an exhaustive list of every product in development. First, only new products were listed, which excludes previously approved products that are now being developed for wider use. For example, the dihydroartemisinin + piperaquine combination currently in pre-registration was left out because it was approved in Kenya in 2005 (see table 2), despite being considered by some analysts as part of the pipeline. Second, our reliance on public and commercial sources potentially overlooks other sources.